GARNIER OMBRELLE SPF 45 SPORT- avobenzone, octocrylene, terephthalylidene dicamphor sulfonic acid and titanium dioxide lotion

Garnier Ombrelle SPF 45 Sport by

Drug Labeling and Warnings

Garnier Ombrelle SPF 45 Sport 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

Avobenzone 1.5%

Octocrylene 7%

Terephthalylidene Dicamphor Sulfonic Acid 0.5%

Titanium dioxide 3.3%

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. Avoid contact with textiles.

Directions

Apply generously and evenly 15 minutes before sun exposure. Reapply at least every 2 hours. Use a water resistant sunscreen if swimming or sweating. For use on children less than 6 months of age, consult a health care practitioner.

Inactive ingredients

water, glycerin, propylene glycol, C12-15 alkyl benzoate, cyclohexasiloxane, alcohol denat., isohexadecane, silica, VP/eicosene copolymer, panthenol, poly C10-30 alkyl acrylate, stearic acid, triethanolamine, PEG-100 stearate, glyceryl stearate, phenoxyethanol, potassium cetyl phosphate, dimethicone, aluminum hydroxide, methylparaben, acrylates/C10-30 alkyl acrylate crosspolymer, tocopherol, disodium EDTA, xanthan gum, butylparaben, ethylparaben, isobutylparaben, propylparaben

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GARNIER OMBRELLE SPF 45 SPORT 
avobenzone, octocrylene, terephthalylidene dicamphor sulfonic acid and titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-566
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	15 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	70 mg  in 1 mL
ECAMSULE (UNII: M94R1PM439) (ECAMSULE - UNII:M94R1PM439)	ECAMSULE	5 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	33 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
ALCOHOL (UNII: 3K9958V90M)
ISOHEXADECANE (UNII: 918X1OUF1E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
PANTHENOL (UNII: WV9CM0O67Z)
STEARIC ACID (UNII: 4ELV7Z65AP)
TROLAMINE (UNII: 9O3K93S3TK)
PEG-100 STEARATE (UNII: YD01N1999R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
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)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-566-01	200 mL in 1 TUBE; Type 0: Not a Combination Product	01/01/2017

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(49967-566) , pack(49967-566)