CERAVE AM FACIAL MOISTURIZING BROAD SPECTRUM SPF 30 SUNSCREEN- homosalate, meradimate, octinoxate, zinc oxide, and octocrylene lotion 
L'Oreal USA Products, Inc.

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Drug Facts

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

image of a carton

image of a carton
CERAVE AM FACIAL MOISTURIZING BROAD SPECTRUM SPF 30 SUNSCREEN 
homosalate, meradimate, octinoxate, zinc oxide, and octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-015
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate100 mg  in 1 mL
MERADIMATE (UNII: J9QGD60OUZ) (MERADIMATE - UNII:J9QGD60OUZ) MERADIMATE50 mg  in 1 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate50 mg  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene20 mg  in 1 mL
Zinc oxide (UNII: SOI2LOH54Z) (Zinc oxide - UNII:SOI2LOH54Z) Zinc oxide63 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49967-015-011 in 1 CARTON08/03/2017
189 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:49967-015-021 in 1 CARTON08/03/2017
260 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3NDC:49967-015-035 mL in 1 TUBE; Type 0: Not a Combination Product08/03/2017
4NDC:49967-015-041.5 mL in 1 PACKET; Type 0: Not a Combination Product08/03/2017
5NDC:49967-015-051 in 1 CARTON08/03/2017
550 mL in 1 BOTTLE; Type 0: Not a Combination Product
6NDC:49967-015-061 in 1 CARTON08/03/2017
6148 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02008/03/2017
Labeler - L'Oreal USA Products, Inc. (002136794)
Establishment
NameAddressID/FEIBusiness Operations
L'Oreal USA Products, Inc.624244349MANUFACTURE(49967-015) , pack(49967-015)
Establishment
NameAddressID/FEIBusiness Operations
Universal Packaging Systems, Inc.078717086pack(49967-015)

Revised: 12/2023
Document Id: 9e408aae-0e5e-476f-aefe-3b813f3934b7
Set id: 2138f86b-3937-4c2b-9568-d40a745b637d
Version: 7
Effective Time: 20231231
 
L'Oreal USA Products, Inc.