CERAVE DEVELOPED WITH DERMATOLOGISTS SUNSCREEN BROAD SPECTRUM SPF 30 FACE- titanium dioxide, zinc oxide lotion
L'Oreal USA Products Inc

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Drug Facts

Active ingredients

Titanium dioxide 3.7%

Zinc oxide 3.5%

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

Stop use and ask doctor if

rash occurs

When using this product

keep out of eyes. Rinse with water to remove.

Keep out of reach of children.

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

Directions

•

Apply liberally 15 minutes before sun exposure

•

Reapply:

•: After 40 minutes of swimming or sweating
•: Immediately after towel drying
•: 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 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

Inactive Ingredients

water, dimethicone, cetyl dimethicone, butyloctyl salicylate, trimethylsiloxysilicate, styrene/acrylates copolymer, dimethicone PEG-8 laurate, polysorbate 60, ceramide 3, ceramide 6 II, ceramide 1,

cholesterol, phytosphingosine, niacinamide, trisiloxane, isohexadecane, arachidyl alcohol, butylene glycol, polyhydroxystearic acid, hydrated silica, PEG-100 stearate, glyceryl stearate, ascorbic acid, avena sativa (oat) kernel extract, arachidyl glucoside, beeswax, behenyl alcohol, benzyl alcohol, stearic acid, bisabolol, dipotassium glycyrrhizate, ethylhexylglycerin, glycerin, hydroxyethyl acrylate/sodium

acryloyldimethyl taurate copolymer, pantothenic acid/yeast polypeptide, PEG-8, xanthan gum,

polyaminopropyl biguanide, polymethyl methacrylate, alumina, potassium sorbate, retinyl palmitate,

sodium lauroyl lactylate, carbomer, tocopheryl acetate, BHT, disodium EDTA, methicone, methylisothiazolinone, triethoxycaprylylsilane

Other information

Protect this product from excessive heat and direct sun

Questions?

Toll-free number 1-888-768-2915
www.CeraVe.com

image of a label

CERAVE DEVELOPED WITH DERMATOLOGISTS SUNSCREEN BROAD SPECTRUM SPF 30 FACE
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49967-100
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	37 mg in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	35 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
CETYL DIMETHICONE 150 (UNII: 5L694Y0T22)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
DIMETHICONE PEG-8 LAURATE (UNII: 72MF9C2A18)
POLYSORBATE 60 (UNII: CAL22UVI4M)
CERAMIDE NP (UNII: 4370DF050B)
CERAMIDE AP (UNII: F1X8L2B00J)
CERAMIDE 1 (UNII: 5THT33P7X7)
CHOLESTEROL (UNII: 97C5T2UQ7J)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
NIACINAMIDE (UNII: 25X51I8RD4)
TRISILOXANE (UNII: 9G1ZW13R0G)
ISOHEXADECANE (UNII: 918X1OUF1E)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
PEG-100 STEARATE (UNII: YD01N1999R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
OAT (UNII: Z6J799EAJK)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
YELLOW WAX (UNII: 2ZA36H0S2V)
DOCOSANOL (UNII: 9G1OE216XY)
BENZYL ALCOHOL (UNII: LKG8494WBH)
STEARIC ACID (UNII: 4ELV7Z65AP)
LEVOMENOL (UNII: 24WE03BX2T)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
PANTOTHENIC ACID (UNII: 19F5HK2737)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
XANTHAN GUM (UNII: TTV12P4NEE)
POLIHEXANIDE (UNII: 322U039GMF)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
ALUMINUM OXIDE (UNII: LMI26O6933)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
EDETATE DISODIUM (UNII: 7FLD91C86K)
METHICONE (20 CST) (UNII: 6777U11MKT)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49967-100-01	1 in 1 CARTON	01/04/2018	04/30/2021
1		70 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	01/04/2018	04/30/2021

Labeler - L'Oreal USA Products Inc (002136794)

Name	Address	ID/FEI	Business Operations
Establishment
L'Oreal USA Products, Inc.		624244349	MANUFACTURE(49967-100)

Revised: 1/2024

Document Id: 6778eb81-ef55-4296-a2e4-2f5ca1f8080c

Set id: 27d510e7-1b10-4dd4-a207-c811a6264480

Version: 4

Effective Time: 20240130

L'Oreal USA Products Inc