GARNIER OMBRELLE SPORT 30 WATER SWEAT RESISTANT SUNSCREEN- avobenzone, octocryene, terephthalylidene dicamphor sulfonic acid and titanium dioxide lotion

Garnier Ombrelle Sport 30 Water Sweat Resistant Sunscreen by

Drug Labeling and Warnings

Garnier Ombrelle Sport 30 Water Sweat Resistant Sunscreen 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 2.5%

Warnings

For external use only. When using this product avoid contact with eyes. If contact occurs, rinse thoroughlly with water. Do not use on broken skin. Stop use and ask a doctor if rash occurs. Keep out of reach of children. If swallowed get medical help or contact a poison control center right away. 

Directions 

Adults and children over 6 months and up. Apply generously and evenly 15 minutes before sun exposure. Reapply at least every 2 hours, after 40 minutes of swimming or sweating and immediately after towel drying.

Inactive ingredients

water, glycerin, propylene glycol, c12-15- alkyl benzoate, cyclohexasiloxane, alcohol denat., isohexadecane, silica, VP eicosene copolymer, panthenol, poly c10-30 alkyl acrylate, triethanolamine, stearic acid, PEG-100 stearate, glyceryl stearate, phenoxyethanol, potassium cetyl phosphate, dimethicone, methylparaben, aluminum hydroxide, acrylates/c10-30 alkyl acrylate crosspolymer, tocopherol, disodium EDTA, xanthan gum, butylparaben, ethylparaben, isobutylparaben, propylparaben

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GARNIER OMBRELLE SPORT 30 WATER SWEAT RESISTANT SUNSCREEN 
avobenzone, octocryene, terephthalylidene dicamphor sulfonic acid and titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-265
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	25 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)
EICOSYL POVIDONE (UNII: XQQ9MKE2BJ)
PANTHENOL (UNII: WV9CM0O67Z)
TROLAMINE (UNII: 9O3K93S3TK)
STEARIC ACID (UNII: 4ELV7Z65AP)
PEG-100 STEARATE (UNII: YD01N1999R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
DIMETHICONE (UNII: 92RU3N3Y1O)
METHYLPARABEN (UNII: A2I8C7HI9T)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-265-01	200 mL in 1 TUBE; Type 0: Not a Combination Product	04/15/2006	11/17/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
export only		04/15/2006	11/17/2025

Labeler - L'OREAL USA PRODUCTS INC (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L'OREAL USA, INC		624244349	manufacture(49967-265) , pack(49967-265)