CERAVE DEVELOPED WITH DERMATOLOGISTS SKIN RENEWING BRIGHTENING WITH SUNSCREEN BROAD SPECTRUM SPF 30- avobenzone, homosalate, octisalate, and octocrylene lotion

CeraVe Developed with Dermatologists Skin Renewing Brightening with Sunscreen Broad Spectrum SPF 30 by

Drug Labeling and Warnings

CeraVe Developed with Dermatologists Skin Renewing Brightening with Sunscreen Broad Spectrum SPF 30 by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, L'Oreal USA Products, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone 3%

Homosalate 5%

Octisalate 5%

Octocrylene 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 no 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 generously 15 minutes before sun exposure
• reapply at least every 2 hours
• use a water resistant sunscreen if swimming or sweating
• 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

Other information

• protect the product in this container from excessive heat or direct sun

Inactive ingredients

water, glycerin, niacinamide, dimethicone, aluminum starch octenylsuccinate, isopropyl isostearate, isohexadecane, squalane, boron nitride, potassium hydroxide, ceramide NP, ceramide AP, ceramide EOP, carbomer, sorbitan oleate, glyceryl stearate, behenyl alcohol, 2-mercaptonicotinoyl glycine, cetearyl alcohol, cetearyl glucoside, triethyl citrate, behentrimonium methosulfate, sodium acrylate/ sodium acryloyldimethyl taurate copolymer, sodium hyaluronate, sodium thiosulfate, sodium lauroyl lactylate, cholesterol, phenoxyethanol, carnosine, ammonium acryloyldimethyltaurate/VP copolymer, tocopherol, hydroxyacetophenone, caprylyl glycol, trisodium ethylenediamine disuccinate, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, phytosphingosine, xanthan gum, cetyl alcohol, polysorbate 80, benzoic acid, PEG-100 stearate

Questions or comments?

Toll-free number 1-888-768-2915

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CERAVE DEVELOPED WITH DERMATOLOGISTS SKIN RENEWING BRIGHTENING WITH SUNSCREEN BROAD SPECTRUM SPF 30 
avobenzone, homosalate, octisalate, and octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-360
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	50 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (ETHYLHEXYL SALICYLATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	70 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
NIACINAMIDE (UNII: 25X51I8RD4)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
ISOPROPYL ISOSTEARATE (UNII: C67IXB9Y7T)
ISOHEXADECANE (UNII: 918X1OUF1E)
SQUALANE (UNII: GW89575KF9)
BORON NITRIDE (UNII: 2U4T60A6YD)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
CERAMIDE NP (UNII: 4370DF050B)
CERAMIDE AP (UNII: F1X8L2B00J)
CARBOMER (UNII: 0A5MM307FC)
SORBITAN OLEATE (UNII: 06XEA2VD56)
GLYCERYL STEARATE (UNII: 230OU9XXE4)
BEHENYL ALCOHOL (UNII: 9G1OE216XY)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61)
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
SODIUM THIOSULFATE (UNII: HX1032V43M)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
CHOLESTEROL (UNII: 97C5T2UQ7J)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CARNOSINE (UNII: 8HO6PVN24W)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
TOCOPHEROL (UNII: R0ZB2556P8)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE (UNII: 255PIF62MS)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
XANTHAN GUM (UNII: TTV12P4NEE)
CETYL ALCOHOL (UNII: 936JST6JCN)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
BENZOIC ACID (UNII: 8SKN0B0MIM)
PEG-100 STEARATE (UNII: YD01N1999R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-360-01	1 in 1 CARTON	10/01/2025
1		40 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	10/01/2025

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L'Oreal USA Products, Inc.		624244349	manufacture(49967-360) , pack(49967-360)