Safety Data Sheet Section 1: Identification Product identifier Product Name • CeraVe Sunscreen Face Lotion SPF 50 Product Code • 301872205013; 3235PQ Relevant identified uses of the substance or mixture and uses advised against Recommended use • Sunscreen Details of the supplier of the safety data sheet Manufacturer • Valeant Pharmaceuticals North America, LLC 400 Somerset Corporate Blvd. Bridgewater, NJ 08807 United States valeant.com Telephone (General) • 18003214576 Emergency telephone number Manufacturer • 18005355053 US Infotrac Manufacturer • +1 3523233500 International Infotrac This safety data sheet is written to provide health, safety and environmental information for people handling this formulated product in the workplace. It is not intended to provide information relevant to consumer use of the product. UN GHS According to: UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS) Section 2: Hazard Identification Classification of the substance or mixture UN GHS • Eye Mild Irritation 2B Label elements UN GHS WARNING Hazard statements • May cause eye irritation Precautionary statements Prevention • Use personal protective equipment as required. Wash thoroughly after handling. Response • IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention. Storage/Disposal • Keep tightly closed. Store at room temperature 2025ºC (6877ºF), to maintain product integrity. Use before date marked on carton and/or container. Other hazards CeraVe Sunscreen Face Lotion SPF 50 CeraVe Sunscreen Face Lotion SPF 50 CeraVe Sunscreen Face Lotion SPF 50 CeraVe Sunscreen Face Lotion SPF 50 Preparation Date: 24/August/2015 Preparation Date: 24/August/2015 Preparation Date: 24/August/2015 Preparation Date: 24/August/2015 Revision Date: 25/September/2015 Revision Date: 25/September/2015 Revision Date: 25/September/2015 Revision Date: 25/September/2015 Format: GHS Language: English (US) Format: GHS Language: English (US) Format: GHS Language: English (US) Format: GHS Language: English (US) UN GHS UN GHS UN GHS UN GHS Page 1 of 16 Page 1 of 16 Page 1 of 16 Page 1 of 16
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Safety Data Sheet
Section 1: Identification
Product identifierProduct Name • CeraVe Sunscreen Face Lotion SPF 50Product Code • 301872205013; 3235PQ
Relevant identified uses of the substance or mixture and uses advised againstRecommended use • Sunscreen
Details of the supplier of the safety data sheetManufacturer • Valeant Pharmaceuticals North America, LLC
400 Somerset Corporate Blvd. Bridgewater, NJ 08807 United States valeant.com
Telephone (General) • 18003214576
Emergency telephone numberManufacturer • 18005355053 US InfotracManufacturer • +1 3523233500 International Infotrac
This safety data sheet is written to provide health, safety and environmental information for people handling this formulated product in the workplace. It is not intended to provide information relevant to consumer use of the product.
UN GHS According to: UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS)
Section 2: Hazard Identification
Classification of the substance or mixtureUN GHS • Eye Mild Irritation 2B
Label elementsUN GHS
WARNING Hazard statements • May cause eye irritation
Precautionary statementsPrevention • Use personal protective equipment as required.
Wash thoroughly after handling. Response • IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses,
if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention.
Storage/Disposal • Keep tightly closed. Store at room temperature 2025ºC (6877ºF), to maintain product integrity. Use before date marked on carton and/or container.
Other hazards
CeraVe Sunscreen Face Lotion SPF 50CeraVe Sunscreen Face Lotion SPF 50CeraVe Sunscreen Face Lotion SPF 50CeraVe Sunscreen Face Lotion SPF 50
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UN GHS • No data available
Section 3 Composition/Information on Ingredients
Substances
• Material does not meet the criteria of a substance according to United Nations Globally Harmonized System of Classification and Labelling of Chemicals (GHS)
Mixtures
CompositionChemical Name Identifiers % Classifications According to
Regulation/DirectiveAluminum oxide, hydrate CAS:1333842 N/A UN GHS: NDA
trimethylsiloxy silicate CAS:56275015 N/A UN GHS: NDA
Trisiloxane CAS:107517 EINECS:2034974
N/A UN GHS: NDA
Water CAS:7732185 EINECS:2317912
N/A UN GHS: Classification criteria not met
Xanthan gum EINECS:2343942 N/A UN GHS: NDA
Zinc oxide CAS:1314132 EINECS:2152225
4.7% UN GHS: NDA
Section 4: FirstAid Measures
Description of first aid measuresInhalation • No specific treatment is necessary since this material is not likely to be hazardous by
inhalation. If exposed to excessive levels of mists, remove to fresh air and get medical attention.
Skin • For accidental and nontherapeutic exposures, immediately flush skin with large amounts of water. Remove contaminated clothing. If irritation (redness, rash, blistering) develops, get medical attention.
Eye • IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention.
Ingestion • Call a physician or poison control center.
Most important symptoms and effects, both acute and delayed• No data available
Indication of any immediate medical attention and special treatment neededOther information
• Have the product container or label with you when calling a poison control center or doctor, or going for treatment.
Section 5: FireFighting Measures
Extinguishing mediaSuitable Extinguishing Media • Water spray, carbon dioxide, dry chemical powder or appropriate foam for surrounding
fire.
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Unsuitable Extinguishing Media
• No data available
Special hazards arising from the substance or mixtureUnusual Fire and Explosion Hazards
• None known product is not flammable or combustible.
Hazardous Combustion Products
• No data available
Advice for firefighters• As in any fire, wear selfcontained breathing apparatus and full protective gear to prevent contact with skin and eyes.
Section 6 Accidental Release Measures
Personal precautions, protective equipment and emergency proceduresPersonal Precautions • No special controls or personal protection required under conditions of intended use.
In the event of bulk spills, wear suitable protective eyewear, clothing, protective boots and protective gloves. Refer to Section 8.
Emergency Procedures • No emergency procedures are expected to be necessary when used in accordance with product literature.
Environmental precautions• No data available
Methods and material for containment and cleaning upContainment/Cleanup Measures
• Contain spilled product. For small spills, add suitable absorbent material. Scoop up and place in an appropriate liquidtight container equipped with a tight cover for disposal. For large spills, dike spilled material or otherwise contain material to ensure runoff does not reach a waterway. Place spilled material in an appropriate, liquidtight container equipped with a tight cover for disposal.
Section 7 Handling and Storage
Precautions for safe handlingHandling • No special handling is required. Refer to Section 8. Use only in accordance with
product literature.Conditions for safe storage, including any incompatibilitiesStorage • Keep tightly closed and store in upright position. Store at room temperature 2025ºC
(6877ºF).
Section 8 Exposure Controls/Personal Protection
Control parametersExposure Limits/Guidelines • Refer to the occupational exposure limits / guidelines for the individual product
components.
Exposure Limits/GuidelinesResult ACGIH Canada Quebec NIOSH OSHA Other Agency
Information
BHT (128370)
STELs Not established 10 mg/m3 STEV Not established Not established Not established
TWAs2 mg/m3 TWA (inhalable fraction and vapor)
Not established 10 mg/m3 TWA Not established Not established
15 mg/m3 TWA (mist,
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Glycerin (56815) TWAs Not established 10 mg/m3 TWAEV
(mist) Not established total particulate); 5 mg/m3 TWA (mist, respirable fraction)
Not established
Benzyl alcohol (100516) TWAs Not established Not established Not established Not established 10 ppm TWA
PEG8 (25322683) TWAs Not established Not established Not established Not established 10 mg/m3 TWA
(MW>200, aerosol)
Silica (7631869) TWAs Not established Not established 6 mg/m3 TWA Not established Not established
Zinc oxide (1314132)
STELs 10 mg/m3 STEL (respirable fraction)
10 mg/m3 STEV (fume)
10 mg/m3 STEL (fume) Not established Not established
TWAs 2 mg/m3 TWA (respirable fraction)
10 mg/m3 TWAEV (containing no Asbestos and <1% Crystalline silica, total dust); 5 mg/m3 TWAEV (fume)
5 mg/m3 TWA (dust and fume)
5 mg/m3 TWA (fume); 15 mg/m3 TWA (total dust); 5 mg/m3 TWA (respirable fraction)
Not established
Ceilings Not established Not established 15 mg/m3 Ceiling (dust) Not established Not established
Titanium dioxide (13463677) TWAs 10 mg/m3 TWA
10 mg/m3 TWAEV (containing no Asbestos and <1% Crystalline silica, total dust)
Not established 15 mg/m3 TWA (total dust) Not established
Exposure Control Notations
ACGIH •Titanium dioxide (13463677): Carcinogens: (A4 Not Classifiable as a Human Carcinogen) •BHT (128370): Carcinogens: (A4 Not Classifiable as a Human Carcinogen)
Exposure controlsEngineering Measures/Controls
• Good general ventilation should be used. Ventilation rates should be matched to conditions. If applicable, use process enclosures, local exhaust ventilation, or other engineering controls to maintain airborne levels below recommended exposure limits. If exposure limits have not been established, maintain airborne levels to an acceptable level.
Personal Protective EquipmentRespiratory • No respiratory protection required during normal handling.Eye/Face • Avoid contact with the eye. No special controls or personal protection required under
conditions of intended use. In the event of a bulk spill, appropriate eye protection should be worn.
Hands • Gloves are not required under normal handling conditions.Skin/Body • No special personal protection required under conditions of intended use. In the event
of a bulk spill, wear appropriate protective clothing.Environmental Exposure Controls
• No data available
Section 9 Physical and Chemical Properties
Information on Physical and Chemical PropertiesMaterial Description Physical Form Liquid Appearance/Description Smooth, thick offwhite lotion.Color Offwhite Odor No odor.
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Odor Threshold Not relevant General Properties Boiling Point No data available Melting Point/Freezing Point Not relevantDecomposition Temperature Not relevant pH 6.5 to 8.5Specific Gravity/Relative Density 1.04 to 1.07 Water=1 Water Solubility MiscibleViscosity Not relevant Volatility Vapor Pressure Not relevant Vapor Density Not relevantEvaporation Rate Not relevant Flammability Flash Point Not relevant UEL Not relevantLEL Not relevant Autoignition Not relevantBurning Time Not relevant Flammability (solid, gas) Not relevantEnvironmental Octanol/Water Partition coefficient No data available
Section 10: Stability and Reactivity
Reactivity• No dangerous reactions known.
Chemical stability• Stable under normal temperatures and pressures.
Possibility of hazardous reactions• No data available
Conditions to avoid• Extreme heat or cold. Do not freeze.
Incompatible materials• None.
Hazardous decomposition products• None expected.
Section 11 Toxicological Information
Information on toxicological effectsOther Material Information • Toxicological information refers to raw materials only. Concentrations and toxicological
effects are substantially reduced in the product.Components
Titanium dioxide (4.9%)
13463677
Irritation: SkinHuman • 300 µg 3 Day(s)Intermittent • Mild irritation; Multidose Toxicity: InhalationRat TCLo • 10 mg/m³ 6 Hour(s) 13 Week(s)Intermittent; Lungs, Thorax, or Respiration:Fibrosis (interstitial); Lungs, Thorax, or Respiration:Other changes; Biochemical:Metabolism (intermediary):Effect on inflammation or mediation of inflammation; Tumorigen / Carcinogen: InhalationRat • 10 mg/m³ 18 Hour(s) 2 Year(s)Intermittent; Tumorigenic:Carcinogenic by RTECS criteria; Lungs, Thorax, or Respiration:Tumors
Zinc oxide (4.7%)
1314132
Acute Toxicity: Ingestion/OralRat LDLo • >8437 mg/kg; InhalationRat TCLo • 25 mg/m³ 3 Hour(s); Lungs, Thorax, or Respiration:Other changes; Biochemical:Enzyme inhibition, induction, or change in blood or tissue levels:Phosphatases; Biochemical:Metabolism (intermediary):Effect on inflammation or mediation of inflammation; Irritation: EyeRabbit • 500 mg 24 Hour(s) • Mild irritation; SkinRabbit • 500 mg 24 Hour(s) • Mild irritation
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GHS Properties Classification
Respiratory sensitization UN GHS • Classification criteria not met
Serious eye damage/Irritation UN GHS • Eye Mild Irritation 2B
Acute toxicity UN GHS • Classification criteria not met
Aspiration Hazard UN GHS • Classification criteria not met
Carcinogenicity UN GHS • Classification criteria not met
Skin corrosion/Irritation UN GHS • Classification criteria not met
Skin sensitization UN GHS • Classification criteria not met
STOTRE UN GHS • Classification criteria not met
STOTSE UN GHS • Classification criteria not met
Toxicity for Reproduction UN GHS • Classification criteria not met
Germ Cell Mutagenicity UN GHS • Classification criteria not met
Potential Health EffectsInhalationAcute (Immediate) • Under normal conditions of use, no health effects are expected.Chronic (Delayed) • Under normal conditions of use, no health effects are expected.
SkinAcute (Immediate) • Under normal conditions of use, no health effects are expected.Chronic (Delayed) • Under normal conditions of use, no health effects are expected.
EyeAcute (Immediate) • Causes mild eye irritation with direct contact to eye.Chronic (Delayed) • Under normal conditions of use, no health effects are expected.
IngestionAcute (Immediate) • Under normal conditions of use, no health effects are expected.Chronic (Delayed) • Under normal conditions of use, no health effects are expected.
Carcinogenic EffectsCAS IARC NTP
Carbomer 9003014 Group 3Not Classifiable Not Listed
Cholesterol 57885 Group 3Not Classifiable Not Listed
LAscorbic acid 50817 Not Listed Evidence of Carcinogenicity
BHT 128370 Group 3Not Classifiable Evidence of Carcinogenicity
Polymethyl methacrylate 9011147 Group 3Not Classifiable Not Listed
Benzyl alcohol 100516 Not Listed Evidence of Carcinogenicity
Silica 7631869 Group 3Not Classifiable Not Listed
Titanium dioxide 13463677 Group 2BPossible Carcinogen Evidence of Carcinogenicity
Section 12 Ecological Information
Toxicity
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• Titanium dioxide 13463677
classification does not apply. For more information, consult the section Substance Specific Issues Titanium dioxide, mixture containing on Health Canada's WHMIS Division website.)
• Titanium dioxide as Titanium compounds Not Listed
• Zinc oxide 1314132 Uncontrolled product according to WHMIS classification criteria
• Zinc oxide as Zinc compounds Not Listed
• Silica 7631869 Uncontrolled product according to WHMIS classification criteria
• Polysorbate 60 9005678 Not Listed • Polyhydroxystearic acid 27924998 Not Listed • Styrene/Acrylates Copolymer 25034860 Not Listed • Arachidyl alcohol 629969 Not Listed • Behenyl alcohol 661198 Not Listed
• PEG100 stearate 9004993 Uncontrolled product according to WHMIS classification criteria
• isohexadecane 4390049 Not Listed • butyloctyl salicylate 190085417 Not Listed • trimethylsiloxy silicate 56275015 Not Listed • Cetyl Dimethicone 191044492 Not Listed • Dimethicone 63148629 Not Listed • Dimethicone PEG8 Laurate 35179863 Not Listed
Canada WHMIS Ingredient Disclosure List
• Methylisothiazolinone 2682204 Not Listed • Butylene glycol 107880 0.1 % • Trisiloxane 107517 Not Listed • PEG8 25322683 Not Listed • Titanium dioxide 13463677 Not Listed • Titanium dioxide as Titanium compounds Not Listed • Zinc oxide 1314132 1 % • Zinc oxide as Zinc compounds Not Listed • Silica 7631869 1 % • Polysorbate 60 9005678 Not Listed • Polyhydroxystearic acid 27924998 Not Listed • Styrene/Acrylates Copolymer 25034860 Not Listed • Arachidyl alcohol 629969 Not Listed • Behenyl alcohol 661198 Not Listed • PEG100 stearate 9004993 1 % • isohexadecane 4390049 Not Listed • butyloctyl salicylate 190085417 Not Listed • trimethylsiloxy silicate 56275015 Not Listed • Cetyl Dimethicone 191044492 Not Listed • Dimethicone 63148629 Not Listed • Dimethicone PEG8 Laurate 35179863 Not Listed
Europe
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• Zinc oxide 1314132 S:6061 • Zinc oxide as Zinc compounds Not Listed • Silica 7631869 Not Listed • Polysorbate 60 9005678 Not Listed • Polyhydroxystearic acid 27924998 Not Listed • Styrene/Acrylates Copolymer 25034860 Not Listed • Arachidyl alcohol 629969 Not Listed • Behenyl alcohol 661198 Not Listed • PEG100 stearate 9004993 Not Listed • isohexadecane 4390049 Not Listed • butyloctyl salicylate 190085417 S:61 • trimethylsiloxy silicate 56275015 Not Listed • Cetyl Dimethicone 191044492 Not Listed • Dimethicone 63148629 Not Listed • Dimethicone PEG8 Laurate 35179863 Not Listed
United StatesEnvironment
U.S. CERCLA/SARA Section 313 Emission Reporting
• Methylisothiazolinone 2682204 Not Listed • Butylene glycol 107880 Not Listed • Trisiloxane 107517 Not Listed • PEG8 25322683 Not Listed • Titanium dioxide 13463677 Not Listed • Titanium dioxide as Titanium compounds Not Listed • Zinc oxide 1314132 Not Listed
• Zinc oxide as Zinc compounds 1.0 % de minimis concentration (listed under Chemical Category N982)
• Silica 7631869 Not Listed • Polysorbate 60 9005678 Not Listed • Polyhydroxystearic acid 27924998 Not Listed • Styrene/Acrylates Copolymer 25034860 Not Listed • Arachidyl alcohol 629969 Not Listed • Behenyl alcohol 661198 Not Listed • PEG100 stearate 9004993 Not Listed • isohexadecane 4390049 Not Listed • butyloctyl salicylate 190085417 Not Listed • trimethylsiloxy silicate 56275015 Not Listed • Cetyl Dimethicone 191044492 Not Listed • Dimethicone 63148629 Not Listed • Dimethicone PEG8 Laurate 35179863 Not Listed
U.S. RCRA (Resource Conservation & Recovery Act) List for Hazardous Constituents• Methylisothiazolinone 2682204 Not Listed • Butylene glycol 107880 Not Listed • Trisiloxane 107517 Not Listed • PEG8 25322683 Not Listed • Titanium dioxide 13463677 Not Listed • Titanium dioxide as Titanium compounds Not Listed • Zinc oxide 1314132 Not Listed • Zinc oxide as Zinc compounds Not Listed • Silica 7631869 Not Listed
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• Polysorbate 60 9005678 Not Listed • Polyhydroxystearic acid 27924998 Not Listed • Styrene/Acrylates Copolymer 25034860 Not Listed • Arachidyl alcohol 629969 Not Listed • Behenyl alcohol 661198 Not Listed • PEG100 stearate 9004993 Not Listed • isohexadecane 4390049 Not Listed • butyloctyl salicylate 190085417 Not Listed • trimethylsiloxy silicate 56275015 Not Listed • Cetyl Dimethicone 191044492 Not Listed • Dimethicone 63148629 Not Listed • Dimethicone PEG8 Laurate 35179863 Not Listed
U.S. RCRA (Resource Conservation & Recovery Act) TSD Facilities Ground Water Monitoring
• Methylisothiazolinone 2682204 Not Listed • Butylene glycol 107880 Not Listed • Trisiloxane 107517 Not Listed • PEG8 25322683 Not Listed • Titanium dioxide 13463677 Not Listed • Titanium dioxide as Titanium compounds Not Listed • Zinc oxide 1314132 Not Listed • Zinc oxide as Zinc compounds Not Listed • Silica 7631869 Not Listed • Polysorbate 60 9005678 Not Listed • Polyhydroxystearic acid 27924998 Not Listed • Styrene/Acrylates Copolymer 25034860 Not Listed • Arachidyl alcohol 629969 Not Listed • Behenyl alcohol 661198 Not Listed • PEG100 stearate 9004993 Not Listed • isohexadecane 4390049 Not Listed • butyloctyl salicylate 190085417 Not Listed • trimethylsiloxy silicate 56275015 Not Listed • Cetyl Dimethicone 191044492 Not Listed • Dimethicone 63148629 Not Listed • Dimethicone PEG8 Laurate 35179863 Not Listed
United States CaliforniaEnvironment
U.S. California Proposition 65 Carcinogens List• Methylisothiazolinone 2682204 Not Listed • Butylene glycol 107880 Not Listed • Trisiloxane 107517 Not Listed • PEG8 25322683 Not Listed
• Titanium dioxide 13463677 carcinogen, initial date 9/2/11 (airborne, unbound particles of respirable size)
• Titanium dioxide as Titanium compounds Not Listed • Zinc oxide 1314132 Not Listed • Zinc oxide as Zinc compounds Not Listed • Silica 7631869 Not Listed • Polysorbate 60 9005678 Not Listed • Polyhydroxystearic acid 27924998 Not Listed • Styrene/Acrylates Copolymer 25034860 Not Listed
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• Dimethicone PEG8 Laurate 35179863 Not Listed
U.S. California Proposition 65 Reproductive Toxicity Male
• Methylisothiazolinone 2682204 Not Listed • Butylene glycol 107880 Not Listed • Trisiloxane 107517 Not Listed • PEG8 25322683 Not Listed • Titanium dioxide 13463677 Not Listed • Titanium dioxide as Titanium compounds Not Listed • Zinc oxide 1314132 Not Listed • Zinc oxide as Zinc compounds Not Listed • Silica 7631869 Not Listed • Polysorbate 60 9005678 Not Listed • Polyhydroxystearic acid 27924998 Not Listed • Styrene/Acrylates Copolymer 25034860 Not Listed • Arachidyl alcohol 629969 Not Listed • Behenyl alcohol 661198 Not Listed • PEG100 stearate 9004993 Not Listed • isohexadecane 4390049 Not Listed • butyloctyl salicylate 190085417 Not Listed • trimethylsiloxy silicate 56275015 Not Listed • Cetyl Dimethicone 191044492 Not Listed • Dimethicone 63148629 Not Listed • Dimethicone PEG8 Laurate 35179863 Not Listed
Section 16 Other Information
Revision Date • 25/September/2015Last Revision Date • 24/August/2015Preparation Date • 24/August/2015Disclaimer/Statement of Liability
• To the best of our knowledge, the information contained herein is accurate. However, neither Valeant Pharmaceuticals International, Inc. nor any of its subsidiaries assumes any liability whatsoever for the accuracy or completeness of the information contained herein. Final determination of suitability of any material is the sole responsibility of the user. All materials may present unknown hazards and should be used with caution. Although certain hazards are described herein, we cannot guarantee that these are the only hazards that exist. NO WARRANTY, EXPRESS OR IMPLIED, OF MERCHANTABILITY, FITNESS OR OTHERWISE IS MADE. In no event shall Valeant Pharmaceuticals International, Inc. or any of its subsidiaries be liable for any special, incidental or consequential damages.
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