CERAVE DEVELOPED WITH DERMATOLOGISTS HYDRATING SUNSCREEN SPF 30 FACE LIGHTWEIGHT, NON-GREASY FEEL 3 ESSENTIAL CERAMIDES NIACINAMIDE MINERAL SUNSCREEN- titanium dioxide and zinc oxide lotion

CERAVE DEVELOPED WITH DERMATOLOGISTS HYDRATING SUNSCREEN SPF 30 FACE LIGHTWEIGHT, NON-GREASY FEEL 3 ESSENTIAL CERAMIDES NIACINAMIDE MINERAL SUNSCREEN by

Drug Labeling and Warnings

CERAVE DEVELOPED WITH DERMATOLOGISTS HYDRATING SUNSCREEN SPF 30 FACE LIGHTWEIGHT, NON-GREASY FEEL 3 ESSENTIAL CERAMIDES NIACINAMIDE MINERAL SUNSCREEN 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

Titanium dioxide 6%

Zinc oxide 5%

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:
   o limit time in the sun, especially from 10 a.m. – 2 p.m.
   o 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 heat and direct sun

Inactive ingredients

water, glycerin, C12-15 alkyl benzoate, dimethicone, glyceryl stearate, isododecane, butyloctyl salicylate, styrene/acrylates copolymer, propanediol, stearic acid, PEG-100 sterate, sorbitan stearate, niacinamide, acrylates/dimethicone copolymer, PEG-8 laurate, ceramide NP, ceramide AP, ceramide EOP, sorbitan isostearate, carbomer, cetearyl alcohol, ceteareth-20, triethoxycaprylylsilane, dimethiconol, sodium citrate, sodium lauroyl lactylate, sodium dodecylbenzenesulfonate, myristic acid, sodium hyaluronate, cholesterol, aluminum hydroxide, palmitic acid, phenoxyethanol, chlorphenesin, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, caprylyl glycol, citric acid, panthenol, xanthan gum, phytosphingosine, polyhydroxystearic acid, polysorbate 60, ethylhexylglycerin

Questions or comments?

Toll-free number 1-888-768-2915

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CERAVE DEVELOPED WITH DERMATOLOGISTS HYDRATING SUNSCREEN SPF 30 FACE LIGHTWEIGHT, NON-GREASY FEEL 3 ESSENTIAL CERAMIDES NIACINAMIDE MINERAL SUNSCREEN 
titanium dioxide and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-150
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	60 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ISODODECANE (UNII: A8289P68Y2)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
PROPANEDIOL (UNII: 5965N8W85T)
STEARIC ACID (UNII: 4ELV7Z65AP)
PEG-100 STEARATE (UNII: YD01N1999R)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
NIACINAMIDE (UNII: 25X51I8RD4)
PEG-8 LAURATE (UNII: 762O8IWA10)
CERAMIDE NP (UNII: 4370DF050B)
CERAMIDE AP (UNII: F1X8L2B00J)
CERAMIDE 1 (UNII: 5THT33P7X7)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
SODIUM DODECYLBENZENESULFONATE (UNII: 554127163Y)
MYRISTIC ACID (UNII: 0I3V7S25AW)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
CHOLESTEROL (UNII: 97C5T2UQ7J)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
PALMITIC ACID (UNII: 2V16EO95H1)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CHLORPHENESIN (UNII: I670DAL4SZ)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PANTHENOL (UNII: WV9CM0O67Z)
XANTHAN GUM (UNII: TTV12P4NEE)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
POLYSORBATE 60 (UNII: CAL22UVI4M)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-150-01	1 in 1 CARTON	02/01/2019
1		75 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/01/2019

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L'OREAL USA PRODUCTS, INC.		624244349	manufacture(49967-150)