Label: GARNIER OMBRELLE SPF 30 COMPLETE UVA UVB SENSITIVE ADVANCED SUNSCREEN FOR SENSITIVE SKIN HYPOALLERGENIC NON COMEDOGENIC QUICK ABSORPTION WATER/SWEAT RESISTANT 80 MINUTES- homosalate, octocrylene, octisalate, avobenzone and drometrizole trisiloxane lotion
- NDC Code(s): 49967-755-01, 49967-755-02
- 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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Other
Aqua, Propanediol, Silica, Caprylic/Capric Triglyceride, Pentaerythrityl Tetraethylhexanoate, Styrene/acrylates Copolymer, Butyloctyl Salicylate, Dicaprylyl Carbonate, Methyl Methacrylate Crosspolymer, Nylon-12, PEG-100 Stearate, Glyceryl Stearate, Perlite, Cara Alba, p-Anisic Acid, t-Butyl Alcohol, Tocopherol, Sodium Stearoyl Glutamate, Phenoxyethanol, PEG-8 Laurate, Behenyl Alcohol, Chlorphenesin, Ammonium Polyacryloylmethyl Taurate, Xanthan Gum Disodium EDTA
- Technology
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Directions
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. For use on children less than 6 months of age, consult a health care practitioner.
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: limiting time in the sun, especially from 10 a.m. – 2 p.m., and wearing long-sleeved shirts, pants, hats, and sunglasses. -
Caution
For external use only. Do not use on damaged or broken skin. If rash occurs, discontinue use and consult a health care practitioner. Keep product out of eyes. IF contact occurs, rinse with water to remove. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Centre right away. Do not expose babies and young children directly to the sun. Avoid contact with textiles.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
GARNIER OMBRELLE SPF 30 COMPLETE UVA UVB SENSITIVE ADVANCED SUNSCREEN FOR SENSITIVE SKIN HYPOALLERGENIC NON COMEDOGENIC QUICK ABSORPTION WATER/SWEAT RESISTANT 80 MINUTES
homosalate, octocrylene, octisalate, avobenzone and drometrizole trisiloxane lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-755 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) homosalate 70 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 70 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 mL DROMETRIZOLE TRISILOXANE (UNII: HC22845I1X) (AVOBENZONE - UNII:G63QQF2NOX) DROMETRIZOLE TRISILOXANE 5 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PROPANEDIOL (UNII: 5965N8W85T) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) PENTAERYTHRITYL TETRAETHYLHEXANOATE (UNII: XJ7052W897) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q) NYLON-12 (UNII: 446U8J075B) PEG-100 STEARATE (UNII: YD01N1999R) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PERLITE (UNII: 0SG101ZGK9) WHITE WAX (UNII: 7G1J5DA97F) P-ANISIC ACID (UNII: 4SB6Y7DMM3) CHLORPHENESIN (UNII: I670DAL4SZ) EDETATE DISODIUM (UNII: 7FLD91C86K) DOCOSANOL (UNII: 9G1OE216XY) PEG-8 LAURATE (UNII: 762O8IWA10) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) TERT-BUTYL ALCOHOL (UNII: MD83SFE959) TOCOPHEROL (UNII: R0ZB2556P8) XANTHAN GUM (UNII: TTV12P4NEE) AMMONIUM POLYACRYLOYLDIMETHYL TAURATE (55000 MPA.S) (UNII: F01RIY4371) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49967-755-01 1 in 1 CARTON 01/19/2019 1 200 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:49967-755-02 1 in 1 CARTON 01/19/2019 2 90 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date export only 01/19/2019 Labeler - L'Oreal USA Products Inc (002136794) Establishment Name Address ID/FEI Business Operations L'OREAL USA PRODUCTS, INC. 624244349 manufacture(49967-755)
