CeraVe AM Facial Moisturizing Broad Spectrum SPF 30 Sunscreen: Package Insert and Label Information

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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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

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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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Homosalate (Homosalate) Homosalate 100 mg in 1 mL
MERADIMATE (MERADIMATE) MERADIMATE 50 mg in 1 mL
Octinoxate (Octinoxate) Octinoxate 50 mg in 1 mL
Octocrylene (Octocrylene) Octocrylene 20 mg in 1 mL
Zinc oxide (Zinc oxide) Zinc oxide 63 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
NIACINAMIDE
CETOSTEARYL ALCOHOL
GLYCERIN
DIMETHICONE
BEHENTRIMONIUM METHOSULFATE
CERAMIDE 3
CERAMIDE 6 II
CERAMIDE 1
HYALURONIC ACID
SODIUM HYDROXIDE
ALUMINUM STARCH OCTENYLSUCCINATE
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)
METHYLPARABEN
EDETATE DISODIUM
PROPYLPARABEN
SODIUM LAUROYL LACTYLATE
PHYTOSPHINGOSINE
CHOLESTEROL
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)
XANTHAN GUM
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49967-015-01 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
1 89 mL in 1 BOTTLE, PLASTIC This package is contained within the CARTON (49967-015-01)
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 Operations
L’Orel USA Products, Inc. 624244349 MANUFACTURE (49967-015)

Revised: 01/2020 L’Oreal USA Products, Inc.

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