CERAVE DEVELOPED WITH DERMATOLOGISTS HYDRATING SHEER SUNSCREEN BROAD SPECTRUM SPF 30 FACE AND BODY WATER RESISTANT 80 MINUTES HYBRID FORMULA- homosalate, octisalate, octocrylene, and zinc oxide lotion 
L'Oreal USA Products, Inc.

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Drug Facts

Active ingredients

Homosalate 6%

Octisalate 5%

Octocrylene 5%

Zinc oxide 7%

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

Warnings

For external use only

Do not use

on damaged or broken skin

When using this product

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

rash occurs

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

For sunscreen use:
● apply liberally 15 minutes before sun exposure
● reapply:

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 value 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-sleeved shirts, pants, hats, and sunglasses
● children under 6 months of age: Ask a doctor

Inactive ingredients


water, c12-15 alkyl benzoate, isohexadecane, isononyl isononanoate, dicaprylyl ether, PEG-30 dipolyhydroxystearate, triethylhexanoin, polyglyceryl-4 isostearate, dicaprylyl carbonate, ethylene/acrylic acid copolymer, triethanolamine, silica, poly c10-30 alkyl acrylate, stearic acid, ceramide NP, ceramide AP, ceramide EOP, carbomer, niacinamide, cetearyl alcohol, triethoxycaprylylsilane, behentrimonium methosulfate, sodium chloride, salicylic acid, sodium hyaluronate, sodium lauroyl lactylate, cholesterol, aluminum stearate, alumina, aluminum hydroxide, iron oxides, phenoxyethanol, p-anisic acid, chlorphenesin, tocoferol, disodium EDTA, disodium stearoyl glutamate, propylene carbonate, citric acid, caprylyl glycol, capryloyl salicylic acid, caprylic/capric triglyceride, diethylhexyl syringylidenemalonate, disteardimonium hectorite, xanthan gum, phytosphingosine, polyhydroxystearic acid, ethylhexylglycerin

Other information

protect the product in this container from excessive heat and direct sun

Questions or comments?

Toll-free number 1-888-768-2915

www.CeraVe.com

image of a carton

image of a carton
CERAVE DEVELOPED WITH DERMATOLOGISTS HYDRATING SHEER SUNSCREEN BROAD SPECTRUM SPF 30 FACE AND BODY WATER RESISTANT 80 MINUTES HYBRID FORMULA 
homosalate, octisalate, octocrylene, and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-832
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE60 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE50 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE70 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
DICAPRYLYL ETHER (UNII: 77JZM5516Z)  
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)  
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
ACRYLIC ACID/ETHYLENE COPOLYMER (600 MPA.S) (UNII: 1PEZ3NLY6I)  
TROLAMINE (UNII: 9O3K93S3TK)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CERAMIDE NP (UNII: 4370DF050B)  
CERAMIDE AP (UNII: F1X8L2B00J)  
CERAMIDE 1 (UNII: 5THT33P7X7)  
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)  
NIACINAMIDE (UNII: 25X51I8RD4)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SALICYLIC ACID (UNII: O414PZ4LPZ)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
ALUMINUM STEARATE (UNII: U6XF9NP8HM)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
P-ANISIC ACID (UNII: 4SB6Y7DMM3)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
TOCOPHEROL (UNII: R0ZB2556P8)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CAPRYLOYL SALICYLIC ACID (UNII: 5F7PJF6AA4)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
XANTHAN GUM (UNII: TTV12P4NEE)  
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
PHYTOSPHINGOSINE HYDROCHLORIDE (UNII: TT871XV7TU)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49967-832-011 in 1 CARTON10/10/2022
189 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:49967-832-025 mL in 1 TUBE; Type 0: Not a Combination Product10/10/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02010/10/2022
Labeler - L'Oreal USA Products, Inc. (002136794)
Establishment
NameAddressID/FEIBusiness Operations
L'Oreal USA Products, Inc.624244349MANUFACTURE(49967-832)

Revised: 12/2023
Document Id: daf3508e-fbc2-4ff6-bad6-84cf73b3db27
Set id: cd69df67-5231-4a75-a9fb-a8669806a892
Version: 2
Effective Time: 20231228
 
L'Oreal USA Products, Inc.