CERAVE DEVELOPED WITH DERMATOLOGISTS HYDRATING SUNSCREEN SPF 50 BODY LIGHTWEIGHT, NON-GREASY FEEL 3 ESSENTIAL CERAMIDES MINERAL SUNSCREEN- 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

• 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, isododecane, styrene/acrylates copolymer, glyceryl stearate, butyloctyl salicylate, dicaprylyl carbonate, propanediol, stearic acid, aluminum hydroxide, PEG-100 stearate, sorbitan stearate, PEG-8 laurate, ceramide NP, ceramide AP, ceramide EOP, sorbitan isostearate, carbomer, cetearyl alcohol, cetearth-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, xanthan gum, phytosphinfosine, polyhydroxystearic acid, polysorbate 60, ethylhexylglycerin

Questions or comments?

Toll-free number 1-888-768-2915

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CERAVE DEVELOPED WITH DERMATOLOGISTS HYDRATING SUNSCREEN SPF 50 BODY LIGHTWEIGHT, NON-GREASY FEEL 3 ESSENTIAL CERAMIDES MINERAL SUNSCREEN 
titanium dioxide and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-911
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)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
ISODODECANE (UNII: A8289P68Y2)  
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)  
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 MONOHYDRATE (UNII: 2968PHW8QP)  
XANTHAN GUM (UNII: TTV12P4NEE)  
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49967-911-011 in 1 CARTON02/01/2019
1150 mL in 1 TUBE; Type 0: Not a Combination Product
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(49967-911)

Revised: 1/2024
Document Id: 4cd9bbcd-14f9-42d2-bfda-3cdf3fa710a5
Set id: 4a243c9f-ca88-47fb-8777-1da79c001c73
Version: 5
Effective Time: 20240116
 
L'Oreal USA Products Inc