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

CeraVe by

Drug Labeling and Warnings

CeraVe by is a Otc medication manufactured, distributed, or labeled by Valeant Pharmaceuticals North America LLC, Ei INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredient	Purpose
Homosalate 10% Meradimate 5%	Sunscreen Sunscreen
Octinoxate 5%	Sunscreen
Octocrylene 2%	Sunscreen
Zinc Oxide 6.3%	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 a doctor ifrash 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:
•   ■ at least every 2 hours
•   ■ use a water-resistant sunscreen if swimming or sweating
•   ■ 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, 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

Otherinformation

•   ■ protect this product from excessive heat and direct sun

Questions?

Toll-free number 800-321-4576

www.CeraVe.com

PRINCIPAL DISPLAY PANEL - 3 FL OZ Bottle

NEW AND

IMPROVED

CeraVe®
DEVELOPED WITH DERMATOLOGISTS

AM

Facial

Moisturizing

Lotion

BROAD SPECTRUM SUNSCREEN SPF 30

FOR NORMAL TO DRY SKIN

MVE DELIVERY TECHNOLOGY

Provides patented controlled

release of ingredients to help

repair and restore your skin's

natural protective barrier.

InvisibleZinc®

Non-comedogenic, non-irritating

With ceramides, niacinamide,

and hyaluronic acid

3 FL OZ (89 mL)

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0187-1365
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: 0187-1365-01	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	06/15/2015

Labeler - Valeant Pharmaceuticals North America LLC (042230623)

Establishment
Name	Address	ID/FEI	Business Operations
Ei INC.		105803274	MANUFACTURE(0187-1365)