Garnier Ombrelle Mineral Face 60 Tinted Sunscreen by L'OREAL USA PRODUCTS INC / L'OREAL USA, INC Drug Facts

Garnier Ombrelle Mineral Face 60 Tinted Sunscreen by

Drug Labeling and Warnings

Garnier Ombrelle Mineral Face 60 Tinted Sunscreen by is a Otc medication manufactured, distributed, or labeled by L'OREAL USA PRODUCTS INC, L'OREAL USA, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

GARNIER OMBRELLE MINERAL FACE 60 TINTED SUNSCREEN- titanium dioxide lotion 
L'OREAL USA PRODUCTS INC

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Drug Facts

Active ingredients

Titanium dioxide 15%

Warnings

For external use only. When using this product avoid contact with eyes. If contact occurs, rinse thoroughlly with water. Do not use on 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 

Adults and children over 6 months and up. Apply generously and evenly 15 minutes before sun exposure. Reapply at least every 2 hours, after 80 minutes of swimming or sweating and immediately after towel drying.

Inactive ingredients

water, isododecane, dimethicone, c12-15 alkyl benzoate, undecane, styrene/acrylates copolymer, caprylyl methicone, nylon-12, butyloctyl salicylate, phenethyl benzoate, dicaprylyl carbonate, silica, triethylhexanoin, isohexadecane, tridecane, dicaprylyl ether, talc, dimethicone/PEG-10/15 crosspolymer, aluminum hydroxide, stearic acid, pentylene glycol, tocopherol, sodium citrate, phenoxyethanol, PEG-9, polydimethylsiloxyethyl dimethicone, magnesium sulfate, PEG-8 laurate, PEG-9, polyhydroxystearic acid, helianthus annuus (sunflower) seed oil, benzoic acid, iron oxides, propylene carbonate, caprylyl glycol, dipropylene glycol, disteardimonium hectorite, disodium stearoyl glutamate, aluminum stearate, alumina

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GARNIER OMBRELLE MINERAL FACE 60 TINTED SUNSCREEN 
titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 49967-745
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ISODODECANE (UNII: A8289P68Y2)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
UNDECANE (UNII: JV0QT00NUE)  
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)  
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
NYLON-12 (UNII: 446U8J075B)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
PHENETHYL BENZOATE (UNII: 0C143929GK)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
TRIDECANE (UNII: A3LZF0L939)  
DICAPRYLYL ETHER (UNII: 77JZM5516Z)  
TALC (UNII: 7SEV7J4R1U)  
DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
TOCOPHEROL (UNII: R0ZB2556P8)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
PEG-8 LAURATE (UNII: 762O8IWA10)  
POLYETHYLENE GLYCOL 450 (UNII: 5IRA46LB71)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  
ALUMINUM STEARATE (UNII: U6XF9NP8HM)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 49967-745-011 in 1 CARTON01/01/201711/12/2024
150 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
export only01/01/201711/12/2024
Labeler - L'OREAL USA PRODUCTS INC (002136794)
Establishment
NameAddressID/FEIBusiness Operations
L'OREAL USA, INC624244349manufacture(49967-745) , pack(49967-745)

Revised: 1/2024