GARNIER OMBRELLE SPF 15 COMPLETE- avobenzone, ensulizole, octocrylene and terephthalylidene dicamphor sulfonic acid lotion

Garnier Ombrelle SPF 15 Complete by

Drug Labeling and Warnings

Garnier Ombrelle SPF 15 Complete 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 3%

Ensulizole 1.5%

Octocrylene 10%

Terephthalylidene Dicamphor Sulfonic Acid 1%

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

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, 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

INGREDIENTS AND APPEARANCE

GARNIER OMBRELLE SPF 15 COMPLETE 
avobenzone, ensulizole, octocrylene and terephthalylidene dicamphor sulfonic acid lotion

Product 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)