GARNIER OMBRELLE FACE MINERAL 50- titanium dioxide and zinc oxide lotion 
L'OREAL USA PRODUCTS INC

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Drug Facts

Active ingredients

Titanium dioxide 9.02%

Zinc oxide 7%

Warnings

For external use only. When using this product avoid contact witheyes. If contact occurs, rinse thoroughlly with water. Do not use on broken skin. Stop use and ask a doctor if rash occurs. Other warnings. Keep out of reach of children. If swallowed get medical help or contact a poison control center right away. 

Directions 

Adults and children over 6 months and up. Apply generously and evenly 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 11 a.m to 3 p.m. and wear long-sleeve shirts, pants, hats and sunglasses.

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, cetearyl alcohol, phenoxyethanol, panthenol, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, PEG-8 laurate, palmitic acid, caprylyl glycol, polyhydroxystearic acid, ceteareth-20, sodium citrate, chlorphenesin, citric acid, xanthan gum, triethoxycaprylylsilane, dimethiconol, sodium dodecylbenzenesulfonate, myristic acid, sorbitan isostearate, polysorbate 60, sodium hyaluronate, tocopherol

image of a label

image of a label
GARNIER OMBRELLE FACE MINERAL 50 
titanium dioxide and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-850
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE90.2 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE70 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)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PANTHENOL (UNII: WV9CM0O67Z)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
PEG-8 LAURATE (UNII: 762O8IWA10)  
PALMITIC ACID (UNII: 2V16EO95H1)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
XANTHAN GUM (UNII: TTV12P4NEE)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
DIMETHICONOL (70 CST) (UNII: MOT8IL21AR)  
SODIUM DODECYLBENZENESULFONATE (UNII: 554127163Y)  
MYRISTIC ACID (UNII: 0I3V7S25AW)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
TOCOPHEROL (UNII: R0ZB2556P8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49967-850-011 in 1 CARTON02/09/2021
175 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
export only02/09/2021
Labeler - L'OREAL USA PRODUCTS INC (002136794)
Establishment
NameAddressID/FEIBusiness Operations
L'OREAL USA, INC624244349manufacture(49967-850) , pack(49967-850)

Revised: 12/2023
Document Id: 7cb4726a-60bf-475b-82a7-be279a586e34
Set id: 8c053842-240a-4eeb-a756-e3268a93d09b
Version: 2
Effective Time: 20231231
 
L'OREAL USA PRODUCTS INC