CERAVE DEVELOPED WITH DERMATOLOGISTS HYDRATING SUNSCREEN SPF 50 FACE LIGHTWEIGHT, NON-GREASY FEEL 3 ESSENTIAL CERAMIDES NIACINAMIDE MINERAL- titanium dioxide and zinc oxide lotion 
L'Oreal USA Products Inc

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Drug Facts

Active ingredients

Titanium dioxide 9%

Zinc oxide 7%

Purpose

Sunscreen

Uses

Warnings

For external use only

Do not use

on damaged or broken skin

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:

Other information

Inactive ingredients

water, glycerin, C12-15 alkyl benzoate, dimethicone, isododecane, styrene/acrylates copolymer, glyceryl stearate, butyloctyl salicylate, dicaprylyl carbonate, propanediol, stearic acid, aluminum hydroxide, PEG-100 stearate, sorbitan stearate, niacinamide, PEG-8 laurate, ceramide NP, ceramide AP, ceramide E0P, sobitan isostearate, carbomer, cetearyl alcohol, ceteareth-20, triethoxycaprylylsilane, dimethiconol, sodium citrate, sodium lauroyl lactylate, sodium dodecylbenzenesulfonate, myristic acid, sodium hyaluronate, cholesterol, palmitic acid, phenoxyethanol, chlorphenesin, tocopherol, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, caprylyl glycol, citric acid, panthenol, xanthan gum, phytosophingosine, polyhydroxystearic acid, polysorbate 60, ethylhexylglycerin

image description

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CERAVE DEVELOPED WITH DERMATOLOGISTS HYDRATING SUNSCREEN SPF 50 FACE LIGHTWEIGHT, NON-GREASY FEEL 3 ESSENTIAL CERAMIDES NIACINAMIDE MINERAL 
titanium dioxide and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-959
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE90 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION70 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ISODODECANE (UNII: A8289P68Y2)  
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
PROPANEDIOL (UNII: 5965N8W85T)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
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)  
PALMITIC ACID (UNII: 2V16EO95H1)  
phenoxyethanol (UNII: HIE492ZZ3T)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
TOCOPHEROL (UNII: R0ZB2556P8)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
PANTHENOL (UNII: WV9CM0O67Z)  
XANTHAN GUM (UNII: TTV12P4NEE)  
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49967-959-011 in 1 CARTON02/01/2019
175 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:49967-959-025 mL in 1 TUBE; Type 0: Not a Combination Product02/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02002/01/2019
Labeler - L'Oreal USA Products Inc (002136794)
Establishment
NameAddressID/FEIBusiness Operations
L'OREAL USA PRODUCTS, INC.624244349manufacture(49967-959)

Revised: 12/2023
Document Id: 537d1f29-e636-45c8-b507-6b49753465a8
Set id: bcf5e724-b40a-49dd-8a09-57cefd7f65ad
Version: 3
Effective Time: 20231231
 
L'Oreal USA Products Inc