![GARNIER OMBRELLE SPF 15 COMPLETE (AVOBENZONE, ENSULIZOLE, OCTOCRYLENE AND TEREPHTHALYLIDENE DICAMPHOR SULFONIC ACID) LOTION [L'OREAL USA PRODUCTS INC]](https://medic.hrt.org//dailymed/images/118c7695-7f83-4885-9733-814d48f51b5b/Omb15Complete.jpg)
| NDC | 49967-001-01, 49967-001-02 |
| Set ID | 118c7695-7f83-4885-9733-814d48f51b5b |
| Category | HUMAN OTC DRUG LABEL |
| Packager | L'Oreal USA Products Inc |
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- Active ingredients
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Warnings
For external use only. Do not use on damaged or broken skin. If rash occurs, discontinue use and consult a health care practitioner. Keep out of eyes. Rinse with water to remove. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Do not expose babies and young children directly to the sun. Avoid contact with textiles.
- Directions
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Inactive ingredients
water, cyclopentasiloxane, glycerin, propylene glycol, isopropyl palmitate, triethanolamine, alcohol denat., VP/eicosene copolymer, dimethicone, panthenol, PEG-100 stearate, glyceryl stearate, phenoxyethanol, stearic acid, methylparaben, acrylates/C10-30 alkyl acrylate crosspolymer, tocopherol, disodium EDTA, xanthan gum, butylparaben, ethylparaben, PEG-4 dilaurate, PEG-4 laurate, isobutylparaben, propylparaben, iodopropynyl butylcarbamate
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
GARNIER OMBRELLE SPF 15 COMPLETE
avobenzone, ensulizole, octocrylene and terephthalylidene dicamphor sulfonic acid lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 mL ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE 15 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 100 mg in 1 mL ECAMSULE (UNII: M94R1PM439) (ECAMSULE - UNII:M94R1PM439) ECAMSULE 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) TROLAMINE (UNII: 9O3K93S3TK) ALCOHOL (UNII: 3K9958V90M) VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3) DIMETHICONE (UNII: 92RU3N3Y1O) PANTHENOL (UNII: WV9CM0O67Z) PHENOXYETHANOL (UNII: HIE492ZZ3T) PEG-100 STEARATE (UNII: YD01N1999R) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) STEARIC ACID (UNII: 4ELV7Z65AP) METHYLPARABEN (UNII: A2I8C7HI9T) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) TOCOPHEROL (UNII: R0ZB2556P8) EDETATE DISODIUM (UNII: 7FLD91C86K) XANTHAN GUM (UNII: TTV12P4NEE) BUTYLPARABEN (UNII: 3QPI1U3FV8) ETHYLPARABEN (UNII: 14255EXE39) PEG-4 DILAURATE (UNII: KCR71CW036) ISOBUTYLPARABEN (UNII: 0QQJ25X58G) PROPYLPARABEN (UNII: Z8IX2SC1OH) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49967-001-01 1 in 1 CARTON 01/01/2017 1 120 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:49967-001-02 1 in 1 CARTON 01/01/2017 2 240 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 01/01/2017 Labeler - L'Oreal USA Products Inc (002136794) Establishment Name Address ID/FEI Business Operations L'OREAL USA, INC. 624244349 manufacture(49967-001) , pack(49967-001)
