GARNIER OMBRELLE FACE MINERAL 50- titanium dioxide and zinc oxide lotion

Garnier Ombrelle Face Mineral 50 by

Drug Labeling and Warnings

Garnier Ombrelle Face Mineral 50 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]

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GARNIER OMBRELLE FACE MINERAL 50 
titanium dioxide and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-850
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	90.2 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	70 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-850-01	1 in 1 CARTON	02/09/2021
1		75 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
export only		02/09/2021

Labeler - L'OREAL USA PRODUCTS INC (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L'OREAL USA, INC		624244349	manufacture(49967-850) , pack(49967-850)