![GARNIER OMBRELLE SPF 45 KIDS HYPOALLERGENIC (OXYBENZONE, OCTISALATE, TITANIUM DIOXIDE, OCTOCRYLENE AND TEREPHTHALYLIDENE DICAMPHOR SULFONIC ACID) LOTION [L'OREAL USA PRODUCTS INC]](https://medic.hrt.org//dailymed/images/e26e4b74-d1ba-4e0f-935b-8d52f792bb8c/Ombrelle SPF 45 Kids Hypoallergenic Lotion.jpg)
| NDC | 49967-493-01, 49967-493-02 |
| Set ID | e26e4b74-d1ba-4e0f-935b-8d52f792bb8c |
| Category | HUMAN OTC DRUG LABEL |
| Packager | L'Oreal USA Products Inc |
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| Product Class | |
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| Application Number |
- Active ingredients
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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 ouf 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 Center right away. Do not expose babies and young children directly to the sun. Avoid contact with textiles.
- Directions
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
GARNIER OMBRELLE SPF 45 KIDS HYPOALLERGENIC
oxybenzone, octisalate, titanium dioxide, octocrylene and terephthalylidene dicamphor sulfonic acid lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-493 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 50 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 42 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 35 mg in 1 mL ECAMSULE (UNII: M94R1PM439) (ECAMSULE - UNII:M94R1PM439) ECAMSULE 30 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 20 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) ALCOHOL (UNII: 3K9958V90M) TROLAMINE (UNII: 9O3K93S3TK) ISOHEXADECANE (UNII: 918X1OUF1E) PEG-100 STEARATE (UNII: YD01N1999R) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3) DIMETHICONE (UNII: 92RU3N3Y1O) PANTHENOL (UNII: WV9CM0O67Z) STEARIC ACID (UNII: 4ELV7Z65AP) PHENOXYETHANOL (UNII: HIE492ZZ3T) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) METHYLPARABEN (UNII: A2I8C7HI9T) TOCOPHEROL (UNII: R0ZB2556P8) EDETATE DISODIUM (UNII: 7FLD91C86K) XANTHAN GUM (UNII: TTV12P4NEE) BUTYLPARABEN (UNII: 3QPI1U3FV8) ETHYLPARABEN (UNII: 14255EXE39) POLYSORBATE 80 (UNII: 6OZP39ZG8H) ISOBUTYLPARABEN (UNII: 0QQJ25X58G) PROPYLPARABEN (UNII: Z8IX2SC1OH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49967-493-01 1 in 1 CARTON 09/24/2011 1 120 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:49967-493-02 1 in 1 CARTON 09/24/2011 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 09/24/2011 Labeler - L'Oreal USA Products Inc (002136794) Establishment Name Address ID/FEI Business Operations L'Oreal USA, Inc. 624244349 manufacture(49967-493) , pack(49967-493)
