ALWAYS FOUNDATION MAKEUP BROAD SPECTRUM SPF 15 DELUXE SAMPLE KIT- homosalate, octisalate, zinc oxide Jafra cosmetics International Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies. ---------- Always Foundation Makeup Broad Spectrum SPF 15 Deluxe Sample Kit Active Ingredients Homosalate 4.25% Purpose Sunscreen Octisalate 4.75% Purpose Sunscreen Zinc Oxide 7.0% Purpose Sunscreen Uses Helps prevent sunburn If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away. Stop use and ask a doctor if rash occurs Warnings For external use only Do not use on damaged or broken skin Stop use and ask a doctor if rash occurs When using this product keep out of eyes. Rinse with water to remove. Directions Apply liberally 15 minutes before sun exposure Use a water resistant sunscreen if swimming or sweating Reapply at least every 2 hours Children under 6 months: Ask a doctor Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 a.m. – 2 p.m. Wear long-sleeve shirts, pants, hats, and sunglasses Inactive Ingredients
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ALWAYS FOUNDATION MAKEUP BROAD SPECTRUM SPF 15 DELUXE SAMPLEKIT- homosalate, octisalate, zinc oxide Jafra cosmetics InternationalDisclaimer: Most OTC drugs are not reviewed and approved by FDA, however they maybe marketed if they comply with applicable regulations and policies. FDA has notevaluated whether this product complies.
----------Always Foundation Makeup Broad Spectrum SPF 15 Deluxe Sample KitActive IngredientsHomosalate 4.25% Purpose SunscreenOctisalate 4.75% Purpose SunscreenZinc Oxide 7.0% Purpose SunscreenUsesHelps prevent sunburnIf used as directed with other sun protection measures (see Directions), decreases therisk of skin cancer and early skin aging caused by the sunKeep out of reach of children.If product is swallowed, get medical help or contact a Poison Control Center right away.Stop use and ask a doctor if rash occursWarningsFor external use onlyDo not use on damaged or broken skinStop use and ask a doctor if rash occursWhen using this product keep out of eyes. Rinse with water to remove.DirectionsApply liberally 15 minutes before sun exposureUse a water resistant sunscreen if swimming or sweatingReapply at least every 2 hoursChildren under 6 months: Ask a doctorSun Protection Measures. Spending time in the sun increases your risk of skincancer and early skin aging. To decrease this risk, regularly use a sunscreen with aBroad Spectrum SPF of 15 or higher and other sun protection measures including:Limit time in the sun, especially from 10 a.m. – 2 p.m.Wear long-sleeve shirts, pants, hats, and sunglassesInactive Ingredients
C12-15 Alkyl Benzoate, Caprylyl Glycol, Caprylyl Methicone, Dimethicone, DimethiconeCrosspolymer, Ethylhexylglycerin, Glycerin, Hexylene Glycol, HydroxypropylcocoatePEG-8 Dimethicone, Iron Oxides/CI 77491/CI 77492/CI 77499, Kaolin, Lecithin,Methicone, Phenoxyethanol, Phenyl Trimethicone, Propylene carbonate, Silica, SilicaDimethyl Silylate, Sodium Chloride, Stoddard solvent, Titanium Dioxide/CI 77891,Triethoxycaprylysilane, Water/AquaProtect this product from excessive heat and direct sunJAFRA beautyalwaysFoundation Makeup Broad Spectrum SPF 15 Deluxe Sample Kit10 testers at 7.5 ml .25 FL OZ (US) eachTotal Contents 75 ml 2.53 FL OZ (US)
ALWAYS FOUNDATION MAKEUP BROAD SPECTRUM SPF 15 DELUXESAMPLE KIT homosalate, octisalate, zinc oxide kit
Product InformationProduct Type HUMAN OTC DRUG Item Code (Source) NDC:68828-432
Packaging# Item Code Package Description Marketing Start
DateMarketing End
Date1 NDC:68828-432-
011 in 1 KIT; Type 0: Not a CombinationProduct 08/21/2020
Quantity of PartsPart # Package Quantity Total Product QuantityPart 1 1 TUBE 7.5 mL in 75 Part 2 1 TUBE 7.5 mL in 75 Part 3 1 TUBE 7.5 mL in 75 Part 4 1 TUBE 7.5 mL in 75 Part 5 1 TUBE 7.5 mL in 75 Part 6 1 TUBE 7.5 mL in 75 Part 7 1 TUBE 7.5 mL in 75 Part 8 1 TUBE 7.5 mL in 75 Part 9 1 TUBE 7.5 mL in 75 Part 10 1 TUBE 7.5 mL in 75
Part 1 of 10ALWAYS FOUNDATION MAKEUP BROAD SPECTRUM SPF 15 SOFTIVORY homosalate, octisalate, zinc oxide cream
Product InformationItem Code (Source) NDC:68828-433
Route of Administration TOPICAL
Active Ingredient/Active MoietyIngredient Name Basis of Strength Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 4.25 g in 100 mLOCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.75 g in 100 mLZINC OXIDE (UNII: SOI2LOH54Z) (Z INC OXIDE - UNII:SOI2LOH54Z) Z INC OXIDE 7 g in 100 mL
Inactive IngredientsIngredient Name Strength
WHITE SPIRIT TYPE 1 (UNII: 37LNJ1I16R)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) DIMETHICONE (UNII: 92RU3N3Y1O) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) SODIUM CHLORIDE (UNII: 451W47IQ8X) GLYCERIN (UNII: PDC6A3C0OX) HYDROXYPROPYLCOCOATE PEG-8 DIMETHICONE (UNII: 8TE0BZU36S) FERRIC OXIDE RED (UNII: 1K09F3G675) KAOLIN (UNII: 24H4NWX5CO) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) METHICONE (20 CST) (UNII: 6777U11MKT) PROPYLENE CARBONATE (UNII: 8D08K3S51E) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII:UF7620L1W6)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) HEXYLENE GLYCOL (UNII: KEH0A3F75J) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) PHENOXYETHANOL (UNII: HIE492ZZ3T) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
Packaging# Item Code Package Description Marketing Start
DateMarketing End
Date1 NDC:68828-
433-017.5 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package
Marketing InformationMarketingCategory
Application Number or MonographCitation
Marketing StartDate
Marketing EndDate
OTC monograph final part352 08/21/2020
Part 2 of 10ALWAYS FOUNDATION MAKEUP BROAD SPECTRUM SPF 15NATURAL TAN homosalate, octisalate, zinc oxide cream
Product Information
Item Code (Source) NDC:68828-434
Route of Administration TOPICAL
Active Ingredient/Active MoietyIngredient Name Basis of Strength Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 4.25 g in 100 mLOCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.75 g in 100 mLZINC OXIDE (UNII: SOI2LOH54Z) (Z INC OXIDE - UNII:SOI2LOH54Z) Z INC OXIDE 7 g in 100 mL
Inactive IngredientsIngredient Name Strength
WHITE SPIRIT TYPE 1 (UNII: 37LNJ1I16R) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) DIMETHICONE (UNII: 92RU3N3Y1O) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) SODIUM CHLORIDE (UNII: 451W47IQ8X) GLYCERIN (UNII: PDC6A3C0OX) HYDROXYPROPYLCOCOATE PEG-8 DIMETHICONE (UNII: 8TE0BZU36S) FERRIC OXIDE RED (UNII: 1K09F3G675) KAOLIN (UNII: 24H4NWX5CO) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) METHICONE (20 CST) (UNII: 6777U11MKT) PROPYLENE CARBONATE (UNII: 8D08K3S51E) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII:UF7620L1W6)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) HEXYLENE GLYCOL (UNII: KEH0A3F75J) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) PHENOXYETHANOL (UNII: HIE492ZZ3T) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
Packaging# Item Code Package Description Marketing Start
DateMarketing End
Date1 NDC:68828-
434-017.5 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package
Marketing Information
MarketingCategory
Application Number or MonographCitation
Marketing StartDate
Marketing EndDate
OTC monograph final part352 08/21/2020
Part 3 of 10ALWAYS FOUNDATION MAKEUP BROAD SPECTRUM SPF 15GOLDEN TAN homosalate, octisalate, zinc oxide cream
Product InformationItem Code (Source) NDC:68828-435
Route of Administration TOPICAL
Active Ingredient/Active MoietyIngredient Name Basis of Strength Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 4.25 g in 100 mLOCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.75 g in 100 mLZINC OXIDE (UNII: SOI2LOH54Z) (Z INC OXIDE - UNII:SOI2LOH54Z) Z INC OXIDE 7 g in 100 mL
Inactive IngredientsIngredient Name Strength
HYDROXYPROPYLCOCOATE PEG-8 DIMETHICONE (UNII: 8TE0BZU36S) FERRIC OXIDE RED (UNII: 1K09F3G675) KAOLIN (UNII: 24H4NWX5CO) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) METHICONE (20 CST) (UNII: 6777U11MKT) PROPYLENE CARBONATE (UNII: 8D08K3S51E) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII:UF7620L1W6)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) HEXYLENE GLYCOL (UNII: KEH0A3F75J) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) PHENOXYETHANOL (UNII: HIE492ZZ3T) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) WHITE SPIRIT TYPE 1 (UNII: 37LNJ1I16R) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) DIMETHICONE (UNII: 92RU3N3Y1O) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) SODIUM CHLORIDE (UNII: 451W47IQ8X) GLYCERIN (UNII: PDC6A3C0OX)
Packaging# Item Code Package Description Marketing Start
DateMarketing End
Date1 NDC:68828-
435-017.5 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package
Marketing InformationMarketingCategory
Application Number or MonographCitation
Marketing StartDate
Marketing EndDate
OTC monograph final part352 08/21/2020
Part 4 of 10ALWAYS FOUNDATION MAKEUP BROAD SPECTRUM SPF 15 COCOA homosalate, octisalate, zinc oxide cream
Product InformationItem Code (Source) NDC:68828-436
Route of Administration TOPICAL
Active Ingredient/Active MoietyIngredient Name Basis of Strength Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 4.25 g in 100 mLOCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.75 g in 100 mLZINC OXIDE (UNII: SOI2LOH54Z) (Z INC OXIDE - UNII:SOI2LOH54Z) Z INC OXIDE 7 g in 100 mL
Inactive IngredientsIngredient Name Strength
HYDROXYPROPYLCOCOATE PEG-8 DIMETHICONE (UNII: 8TE0BZU36S) FERRIC OXIDE RED (UNII: 1K09F3G675) KAOLIN (UNII: 24H4NWX5CO) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) METHICONE (20 CST) (UNII: 6777U11MKT) PROPYLENE CARBONATE (UNII: 8D08K3S51E) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII:UF7620L1W6)
UF7620L1W6)ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) HEXYLENE GLYCOL (UNII: KEH0A3F75J) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) PHENOXYETHANOL (UNII: HIE492ZZ3T) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) WHITE SPIRIT TYPE 1 (UNII: 37LNJ1I16R) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) DIMETHICONE (UNII: 92RU3N3Y1O) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) SODIUM CHLORIDE (UNII: 451W47IQ8X) GLYCERIN (UNII: PDC6A3C0OX)
Packaging# Item Code Package Description Marketing Start
DateMarketing End
Date1 NDC:68828-
436-017.5 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package
Marketing InformationMarketingCategory
Application Number or MonographCitation
Marketing StartDate
Marketing EndDate
OTC monograph final part352 08/21/2020
Part 5 of 10ALWAYS FOUNDATION MAKEUP BROAD SPECTRUM SPF 15 SHELL homosalate, octisalate, zinc oxide cream
Product InformationItem Code (Source) NDC:68828-437
Route of Administration TOPICAL
Active Ingredient/Active MoietyIngredient Name Basis of Strength Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 4.25 g in 100 mLOCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.75 g in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (Z INC OXIDE - UNII:SOI2LOH54Z) Z INC OXIDE 7 g in 100 mL
Inactive IngredientsIngredient Name Strength
WHITE SPIRIT TYPE 1 (UNII: 37LNJ1I16R) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) DIMETHICONE (UNII: 92RU3N3Y1O) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) SODIUM CHLORIDE (UNII: 451W47IQ8X) GLYCERIN (UNII: PDC6A3C0OX) HYDROXYPROPYLCOCOATE PEG-8 DIMETHICONE (UNII: 8TE0BZU36S) FERRIC OXIDE RED (UNII: 1K09F3G675) KAOLIN (UNII: 24H4NWX5CO) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) METHICONE (20 CST) (UNII: 6777U11MKT) PROPYLENE CARBONATE (UNII: 8D08K3S51E) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII:UF7620L1W6)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) HEXYLENE GLYCOL (UNII: KEH0A3F75J) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) PHENOXYETHANOL (UNII: HIE492ZZ3T) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
Packaging# Item Code Package Description Marketing Start
DateMarketing End
Date1 NDC:68828-
437-017.5 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package
Marketing InformationMarketingCategory
Application Number or MonographCitation
Marketing StartDate
Marketing EndDate
OTC monograph final part352 08/21/2020
Part 6 of 10ALWAYS FOUNDATION MAKEUP BROAD SPECTRUM SPF 15 BUFF
homosalate, octisalate, zinc oxide cream
Product InformationItem Code (Source) NDC:68828-438
Route of Administration TOPICAL
Active Ingredient/Active MoietyIngredient Name Basis of Strength Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 4.25 g in 100 mLOCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.75 g in 100 mLZINC OXIDE (UNII: SOI2LOH54Z) (Z INC OXIDE - UNII:SOI2LOH54Z) Z INC OXIDE 7 g in 100 mL
Inactive IngredientsIngredient Name Strength
HYDROXYPROPYLCOCOATE PEG-8 DIMETHICONE (UNII: 8TE0BZU36S) FERRIC OXIDE RED (UNII: 1K09F3G675) KAOLIN (UNII: 24H4NWX5CO) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) METHICONE (20 CST) (UNII: 6777U11MKT) PROPYLENE CARBONATE (UNII: 8D08K3S51E) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII:UF7620L1W6)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) HEXYLENE GLYCOL (UNII: KEH0A3F75J) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) PHENOXYETHANOL (UNII: HIE492ZZ3T) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) WHITE SPIRIT TYPE 1 (UNII: 37LNJ1I16R) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) DIMETHICONE (UNII: 92RU3N3Y1O) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) SODIUM CHLORIDE (UNII: 451W47IQ8X) GLYCERIN (UNII: PDC6A3C0OX)
Packaging# Item Code Package Description Marketing Start
DateMarketing End
Date
1 NDC:68828-438-01
7.5 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package
Marketing InformationMarketingCategory
Application Number or MonographCitation
Marketing StartDate
Marketing EndDate
OTC monograph final part352 08/21/2020
Part 7 of 10ALWAYS FOUNDATION MAKEUP BROAD SPECTRUM SPF 15NATURAL homosalate, octisalate, zinc oxide cream
Product InformationItem Code (Source) NDC:68828-439
Route of Administration TOPICAL
Active Ingredient/Active MoietyIngredient Name Basis of Strength Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 4.25 g in 100 mLOCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.75 g in 100 mLZINC OXIDE (UNII: SOI2LOH54Z) (Z INC OXIDE - UNII:SOI2LOH54Z) Z INC OXIDE 7 g in 100 mL
Inactive IngredientsIngredient Name Strength
HYDROXYPROPYLCOCOATE PEG-8 DIMETHICONE (UNII: 8TE0BZU36S) FERRIC OXIDE RED (UNII: 1K09F3G675) KAOLIN (UNII: 24H4NWX5CO) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) METHICONE (20 CST) (UNII: 6777U11MKT) PROPYLENE CARBONATE (UNII: 8D08K3S51E) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII:UF7620L1W6)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) HEXYLENE GLYCOL (UNII: KEH0A3F75J) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) PHENOXYETHANOL (UNII: HIE492ZZ3T) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
WHITE SPIRIT TYPE 1 (UNII: 37LNJ1I16R) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) DIMETHICONE (UNII: 92RU3N3Y1O) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) SODIUM CHLORIDE (UNII: 451W47IQ8X) GLYCERIN (UNII: PDC6A3C0OX)
Packaging# Item Code Package Description Marketing Start
DateMarketing End
Date1 NDC:68828-
439-017.5 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package
Marketing InformationMarketingCategory
Application Number or MonographCitation
Marketing StartDate
Marketing EndDate
OTC monograph final part352 08/21/2020
Part 8 of 10ALWAYS FOUNDATION MAKEUP BROAD SPECTRUM SPF 15 IVORY homosalate, octisalate, zinc oxide cream
Product InformationItem Code (Source) NDC:68828-440
Route of Administration TOPICAL
Active Ingredient/Active MoietyIngredient Name Basis of Strength Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 4.25 g in 100 mLOCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.75 g in 100 mLZINC OXIDE (UNII: SOI2LOH54Z) (Z INC OXIDE - UNII:SOI2LOH54Z) Z INC OXIDE 7 g in 100 mL
Inactive IngredientsIngredient Name Strength
WHITE SPIRIT TYPE 1 (UNII: 37LNJ1I16R) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) SODIUM CHLORIDE (UNII: 451W47IQ8X) GLYCERIN (UNII: PDC6A3C0OX) HYDROXYPROPYLCOCOATE PEG-8 DIMETHICONE (UNII: 8TE0BZU36S) FERRIC OXIDE RED (UNII: 1K09F3G675) KAOLIN (UNII: 24H4NWX5CO) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) METHICONE (20 CST) (UNII: 6777U11MKT) PROPYLENE CARBONATE (UNII: 8D08K3S51E) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII:UF7620L1W6)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) HEXYLENE GLYCOL (UNII: KEH0A3F75J) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) PHENOXYETHANOL (UNII: HIE492ZZ3T) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
Packaging# Item Code Package Description Marketing Start
DateMarketing End
Date1 NDC:68828-
440-017.5 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package
Marketing InformationMarketingCategory
Application Number or MonographCitation
Marketing StartDate
Marketing EndDate
OTC monograph final part352 08/21/2020
Part 9 of 10ALWAYS FOUNDATION MAKEUP BROAD SPECTRUM SPF 15BISQUE homosalate, octisalate, zinc oxide cream
Product InformationItem Code (Source) NDC:68828-441
Route of Administration TOPICAL
Active Ingredient/Active MoietyIngredient Name Basis of Strength Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 4.25 g in 100 mLOCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.75 g in 100 mLZINC OXIDE (UNII: SOI2LOH54Z) (Z INC OXIDE - UNII:SOI2LOH54Z) Z INC OXIDE 7 g in 100 mL
Inactive IngredientsIngredient Name Strength
WHITE SPIRIT TYPE 1 (UNII: 37LNJ1I16R) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) DIMETHICONE (UNII: 92RU3N3Y1O) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) SODIUM CHLORIDE (UNII: 451W47IQ8X) GLYCERIN (UNII: PDC6A3C0OX) HYDROXYPROPYLCOCOATE PEG-8 DIMETHICONE (UNII: 8TE0BZU36S) FERRIC OXIDE RED (UNII: 1K09F3G675) KAOLIN (UNII: 24H4NWX5CO) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) METHICONE (20 CST) (UNII: 6777U11MKT) PROPYLENE CARBONATE (UNII: 8D08K3S51E) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII:UF7620L1W6)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) HEXYLENE GLYCOL (UNII: KEH0A3F75J) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) PHENOXYETHANOL (UNII: HIE492ZZ3T) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
Packaging# Item Code Package Description Marketing Start
DateMarketing End
Date1 NDC:68828-
441-017.5 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package
Marketing InformationMarketingCategory
Application Number or MonographCitation
Marketing StartDate
Marketing EndDate
OTC monograph final part352 08/21/2020
OTC monograph final part352 08/21/2020
Part 10 of 10ALWAYS FOUNDATION MAKEUP BROAD SPECTRUM SPF 15HONEY homosalate, octisalate, zinc oxide cream
Product InformationItem Code (Source) NDC:68828-442
Route of Administration TOPICAL
Active Ingredient/Active MoietyIngredient Name Basis of Strength Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 4.25 g in 100 mLOCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.75 g in 100 mLZINC OXIDE (UNII: SOI2LOH54Z) (Z INC OXIDE - UNII:SOI2LOH54Z) Z INC OXIDE 7 g in 100 mL
Inactive IngredientsIngredient Name Strength
HYDROXYPROPYLCOCOATE PEG-8 DIMETHICONE (UNII: 8TE0BZU36S) FERRIC OXIDE RED (UNII: 1K09F3G675) KAOLIN (UNII: 24H4NWX5CO) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) METHICONE (20 CST) (UNII: 6777U11MKT) PROPYLENE CARBONATE (UNII: 8D08K3S51E) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII:UF7620L1W6)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) HEXYLENE GLYCOL (UNII: KEH0A3F75J) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) PHENOXYETHANOL (UNII: HIE492ZZ3T) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) WHITE SPIRIT TYPE 1 (UNII: 37LNJ1I16R) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) DIMETHICONE (UNII: 92RU3N3Y1O) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) SODIUM CHLORIDE (UNII: 451W47IQ8X)
Jafra cosmetics International
GLYCERIN (UNII: PDC6A3C0OX)
Packaging# Item Code Package Description Marketing Start
DateMarketing End
Date1 NDC:68828-
442-017.5 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package
Marketing InformationMarketingCategory
Application Number or MonographCitation
Marketing StartDate
Marketing EndDate
OTC monograph final part352 08/21/2020
Marketing InformationMarketingCategory
Application Number or MonographCitation
Marketing StartDate
Marketing EndDate
OTC monograph final part352 08/21/2020
Labeler - Jafra cosmetics International (041676479)
EstablishmentName Address ID/FEI Business Operations
Jafra Manufacturing,S.A. de C.V. 814732061 manufacture(68828-432, 68828-433, 68828-434, 68828-435, 68828-436,
68828-437, 68828-438, 68828-439, 68828-440, 68828-441)
Revised: 4/2021
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