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

CeraVe Developed with Dermatologists Hydrating Sheer Sunscreen Broad Spectrum SPF 30 Face and Body Water Resistant 80 Minutes Hybrid Formula by

Drug Labeling and Warnings

CeraVe Developed with Dermatologists Hydrating Sheer Sunscreen Broad Spectrum SPF 30 Face and Body Water Resistant 80 Minutes Hybrid Formula by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

• after 80 minutes or swimming or sweating
• immediately after towl drying
• at least every 2 hours

● 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

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-832
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	60 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	50 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	70 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-832-01	1 in 1 CARTON	10/10/2022
1		89 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 49967-832-02	5 mL in 1 TUBE; Type 0: Not a Combination Product	10/10/2022
3	NDC: 49967-832-03	150 mL in 1 TUBE; Type 0: Not a Combination Product	10/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	10/10/2022

Labeler - L'Oreal USA Products, Inc. (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L'Oreal USA Products, Inc.		624244349	MANUFACTURE(49967-832)