Label: GARNIER OMBRELLE FACE MINERAL 50- titanium dioxide and zinc oxide lotion
- NDC Code(s): 49967-850-01
- Packager: L'OREAL USA PRODUCTS INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Export only
Drug Label Information
Updated December 31, 2023
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- Official Label (Printer Friendly)
- Active ingredients
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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.
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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.
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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
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INGREDIENTS AND APPEARANCE
GARNIER OMBRELLE FACE MINERAL 50
titanium dioxide and zinc oxide lotionProduct 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)
