GARNIER OMBRELLE SPF 60 COMPLETE LIGHTWEIGHT- homosalate, octocrylene, octisalate, avobenzone, drometrizole trisiloxane and terephthalylidene dicamphor sulfonic acid lotion

Garnier Ombrelle SPF 60 Complete Lightweight by

Drug Labeling and Warnings

Garnier Ombrelle SPF 60 Complete Lightweight by is a Prescription 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

Homosalate 10%

Octocrylene 7%

Octisalate 5%

Avobenzone 4%

Drometrizole Trisiloxane 2.5%

Terephthalylidene Dicamphor Sulfonic Acid 0.5%

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 out of eyes. Rinse with water to remove. Keep out of reach of children. If swallowed get medical help or contact a Poison Control Centre 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.

Others

Aqua, Glycerin, Alcohol Denat., Styrene/Acrylates Copolymer, Dimethicone, Propylene Glycol, PEG-100 Stearate, Glyceryl Stearate, Silica, Synthetic Wax, Phenoxyethanol, Sodium Polyacrylate, Triethanolamine, Stearic Acid, Caprylyl Glycol, Palmitic Acid, PEG-8 Laurate, Xanthan Gum, Tocopherol, Disodium EDTA

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GARNIER OMBRELLE SPF 60 COMPLETE LIGHTWEIGHT 
homosalate, octocrylene, octisalate, avobenzone, drometrizole trisiloxane and terephthalylidene dicamphor sulfonic acid lotion

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 49967-081
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	70 mg  in 1 mL
octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	octisalate	50 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	40 mg  in 1 mL
DROMETRIZOLE TRISILOXANE (UNII: HC22845I1X) (AVOBENZONE - UNII:G63QQF2NOX)	DROMETRIZOLE TRISILOXANE	25 mg  in 1 mL
ECAMSULE (UNII: M94R1PM439) (ECAMSULE - UNII:M94R1PM439)	ECAMSULE	5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ALCOHOL (UNII: 3K9958V90M)
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)
DIMETHICONE (UNII: 92RU3N3Y1O)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PEG-100 STEARATE (UNII: YD01N1999R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TROLAMINE (UNII: 9O3K93S3TK)
STEARIC ACID (UNII: 4ELV7Z65AP)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PALMITIC ACID (UNII: 2V16EO95H1)
PEG-8 LAURATE (UNII: 762O8IWA10)
XANTHAN GUM (UNII: TTV12P4NEE)
TOCOPHEROL (UNII: R0ZB2556P8)
EDETATE DISODIUM (UNII: 7FLD91C86K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-081-01	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/16/2014
2	NDC: 49967-081-02	300 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/16/2014
3	NDC: 49967-081-03	240 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/16/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
export only		12/16/2014

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L'Oreal USA, INC.		624244349	manufacture(49967-081) , pack(49967-081)