CERAVE AM FACIAL MOISTURIZING BROAD SPECTRUM SPF 30 SUNSCREEN- homosalate, meradimate, octinoxate, zinc oxide, and octocrylene lotion

CeraVe AM Facial Moisturizing Broad Spectrum SPF 30 Sunscreen by

Drug Labeling and Warnings

CeraVe AM Facial Moisturizing Broad Spectrum SPF 30 Sunscreen 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 10%

Meradimate 5%

Octinoxate 5%

Octocrylene 2%

Zinc oxide 6.3%

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 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

Inactive ingredients

water, niacinamide, cetearyl alcohol, glycerin, dimethicone, behentrimonium methosulfate, ceramide 3,  ceramide 6-II, ceramide 1, hyaluronic acid, sodium hydroxide, aluminum starch octenylsuccinate, hydroxyethylcellulose, methylparaben, disodium EDTA, propylparaben, sodium lauroyl lactylate, phytosphingosine, cholesterol, carbomer, xanthan gum

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

INGREDIENTS AND APPEARANCE

CERAVE AM FACIAL MOISTURIZING BROAD SPECTRUM SPF 30 SUNSCREEN 
homosalate, meradimate, octinoxate, zinc oxide, and octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-015
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	100 mg  in 1 mL
MERADIMATE (UNII: J9QGD60OUZ) (MERADIMATE - UNII:J9QGD60OUZ)	MERADIMATE	50 mg  in 1 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	50 mg  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	20 mg  in 1 mL
Zinc oxide (UNII: SOI2LOH54Z) (Zinc oxide - UNII:SOI2LOH54Z)	Zinc oxide	63 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
NIACINAMIDE (UNII: 25X51I8RD4)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61)
CERAMIDE 3 (UNII: 4370DF050B)
CERAMIDE 6 II (UNII: F1X8L2B00J)
CERAMIDE 1 (UNII: 5THT33P7X7)
HYALURONIC ACID (UNII: S270N0TRQY)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) (UNII: ZYD53NBL45)
METHYLPARABEN (UNII: A2I8C7HI9T)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
CHOLESTEROL (UNII: 97C5T2UQ7J)
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: F68VH75CJC)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-015-01	1 in 1 CARTON	08/03/2017
1		89 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	08/03/2017

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

Establishment
Name	Address	ID/FEI	Business Operations
L'Orel USA Products, Inc.		624244349	MANUFACTURE(49967-015)