CERAVE DEVELOPED WITH DERMOTOLOGISTS ULTRA LIGHT MOISTURIZING BROAD SPECTRUM SPF 30- avobenzone, homosalate, octisalate and octocrylene lotion

CeraVe Developed with Dermotologists Ultra Light Moisturizing Broad Spectrum SPF 30 by

Drug Labeling and Warnings

CeraVe Developed with Dermotologists Ultra Light Moisturizing Broad Spectrum SPF 30 by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, L'OREAL USA PRODUCTS, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 2.7%

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

Other Information

protect the product in this container from excessive hear and direct sun

Inactive ingredients

water, C12-15 alkyl benzoate, glyceryl stearate SE, methyl methacrylate crosspolymer, glycerin, pentylene glycol, ceramide NP (ceramide 3), ceramide AP (ceramide 6-II), ceramide EOP (ceramide 1), phytosphingosine, sodium acryloyldimethyltaurate/VP crosspolymer, sodium lauroyl lactylate, cholesterol, xanthan gum, carbomer, hydroxyacetophenone, disodium EDTA, citric acid, sodium hyaluronate

Questions or comments?

Toll-free number 1-888-768-2915

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CERAVE DEVELOPED WITH DERMOTOLOGISTS ULTRA LIGHT MOISTURIZING BROAD SPECTRUM SPF 30 
avobenzone, homosalate, octisalate and octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-517
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	27 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
GLYCERIN (UNII: PDC6A3C0OX)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
CERAMIDE NP (UNII: 4370DF050B)
CERAMIDE AP (UNII: F1X8L2B00J)
CERAMIDE 1 (UNII: 5THT33P7X7)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
CHOLESTEROL (UNII: 97C5T2UQ7J)
XANTHAN GUM (UNII: TTV12P4NEE)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-517-01	1 in 1 CARTON	01/22/2018
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 49967-517-02	5 mL in 1 TUBE; Type 0: Not a Combination Product	01/22/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/22/2018

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
Accupac, Inc		071609663	manufacture(49967-517)