GARNIER OMBRELLE SPF 60 COMPLETE UVA UVB SENSITIVE ADVANCED SUNSCREEN FOR SENSITIVE SKIN HYPOALLERGENIC NON COMEDOGENIC QUICK ABSORPTION WATER/SWEAT RESISTANT 80 MINUTES- homosalate, octocrylene, octisalate, avobenzone and drometrizole trisiloxane lotion

Garnier Ombrelle SPF 60 Complete UVA UVB Sensitive Advanced Sunscreen for Sensitive Skin Hypoallergenic Non comedogenic Quick Absorption Water/sweat resistant 80 minutes by

Drug Labeling and Warnings

Garnier Ombrelle SPF 60 Complete UVA UVB Sensitive Advanced Sunscreen for Sensitive Skin Hypoallergenic Non comedogenic Quick Absorption Water/sweat resistant 80 minutes by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, L'OREAL USA PRODUCTS, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Homosalate 15%
Octocrylene 7%
Octisalate 5%
Avobenzone 3%
Drometrizole Trisiloxane 0.5%

Other

Aqua, Silica, Styrene/acrylates Copolymer, Butyloctyl Salicylate, Dicaprylyl Carbonate, Methyl Methacrylate Crosspolymer, Nylon-12, PEG-100 Stearate, Glyceryl Stearate, Perlite, Cara Alba, Ammonium Polyacryloylmethyl Taurate, p-Anisic Acid, Behenyl Alcohol, Chlorphenesin, Disodium EDTA, PEG-8 Laurate, Phenoxyethanol, Sodium Stearoyl Glutamate, t-Butyl Alcohol, Tocopherol, Xanthan Gum

Technology

Ombrelle’s patented filtering system with Mexoryl technology and other sunscreen filters provides effective broad-spectrum UVA/UVB protection.

Directions

Apply generously and evenly 15 minutes before sun exposure. Reapply at least every 2 hours, after 80 minutes of swimming or sweating and immediately after towel drying. For use on children less than 6 months of age, consult a health care practitioner.

SUN PROTECTION MEASURES
Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limiting time in the sun, especially from 10 a.m. – 2 p.m., and wearing long-sleeved shirts, pants, hats, and sunglasses.

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 out 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 Centre right away. Do not expose babies and young children directly to the sun. Avoid contact with textiles.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GARNIER OMBRELLE SPF 60 COMPLETE UVA UVB SENSITIVE ADVANCED SUNSCREEN FOR SENSITIVE SKIN HYPOALLERGENIC NON COMEDOGENIC QUICK ABSORPTION WATER/SWEAT RESISTANT 80 MINUTES 
homosalate, octocrylene, octisalate, avobenzone and drometrizole trisiloxane lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-766
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	homosalate	150 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	30 mg  in 1 mL
DROMETRIZOLE TRISILOXANE (UNII: HC22845I1X) (AVOBENZONE - UNII:G63QQF2NOX)	DROMETRIZOLE TRISILOXANE	5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
NYLON-12 (UNII: 446U8J075B)
PEG-100 STEARATE (UNII: YD01N1999R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PERLITE (UNII: 0SG101ZGK9)
WHITE WAX (UNII: 7G1J5DA97F)
AMMONIUM POLYACRYLOYLDIMETHYL TAURATE (55000 MPA.S) (UNII: F01RIY4371)
P-ANISIC ACID (UNII: 4SB6Y7DMM3)
DOCOSANOL (UNII: 9G1OE216XY)
CHLORPHENESIN (UNII: I670DAL4SZ)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PEG-8 LAURATE (UNII: 762O8IWA10)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
TOCOPHEROL (UNII: R0ZB2556P8)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-766-01	1 in 1 CARTON	01/19/2019
1		200 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 49967-766-02	1 in 1 CARTON	01/19/2019
2		90 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
export only		01/19/2019

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L'OREAL USA PRODUCTS, INC.		624244349	manufacture(49967-766)