GARNIER OMBRELLE COMPLETE SENSITIVE ADVANCED LIGHTWEIGHT HYPOALLERGENIC SPF 45 MEXORYL TECHNOLOGY- homosalate, octocrylene, octisalate, avobenzone and drometrizole trisiloxane lotion

Garnier Ombrelle Complete Sensitive Advanced Lightweight hypoallergenic SPF 45 Mexoryl Technology by

Drug Labeling and Warnings

Garnier Ombrelle Complete Sensitive Advanced Lightweight hypoallergenic SPF 45 Mexoryl Technology 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 12%

Octocrylene 7%

Octisalate 5%

Avobenzone 3%

Drometrizole Trisiloxane 0.5%

Inactive ingredients

aqua, propanediol, silica, styrene/acrylates copolymer, butyloctyl salicylate, dicaprylyl carbonate, methyl methacrylate copolymer, nylon-12, PEG-100 stearate, glyceryl stearate, caprylic/capric triglyceride, pentaerythrityl tetrathylhexanoate, perlite, cera alba, p-anisic acid, t-butyl alcohol, tocopherol, sodium stearoyl glutamate, phenoxyethanol, PEG-8 laurate, behenyl alcohol, chlorphenesin, ammonium polyacryloyldimethyl taurate, xanthan gum, disodium EDTA

Warnings

For external use only

Do not use

on damaged or broken skin

When using this product

avoid contact with eyes. If contact occurs, rinse thoroughly with water.

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 6 months and up. 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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GARNIER OMBRELLE COMPLETE SENSITIVE ADVANCED LIGHTWEIGHT HYPOALLERGENIC SPF 45 MEXORYL TECHNOLOGY 
homosalate, octocrylene, octisalate, avobenzone and drometrizole trisiloxane lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-397
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	120 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) (DROMETRIZOLE TRISILOXANE - UNII:HC22845I1X)	DROMETRIZOLE TRISILOXANE	5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPANEDIOL (UNII: 5965N8W85T)
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)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PENTAERYTHRITYL TETRAETHYLHEXANOATE (UNII: XJ7052W897)
PERLITE (UNII: 0SG101ZGK9)
WHITE WAX (UNII: 7G1J5DA97F)
P-ANISIC ACID (UNII: 4SB6Y7DMM3)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
TOCOPHEROL (UNII: R0ZB2556P8)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PEG-8 LAURATE (UNII: 762O8IWA10)
DOCOSANOL (UNII: 9G1OE216XY)
CHLORPHENESIN (UNII: I670DAL4SZ)
AMMONIUM POLYACRYLOYLDIMETHYL TAURATE (55000 MPA.S) (UNII: F01RIY4371)
XANTHAN GUM (UNII: TTV12P4NEE)
EDETATE DISODIUM (UNII: 7FLD91C86K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-397-01	1 in 1 CARTON	02/05/2020
1		90 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 49967-397-02	1 in 1 CARTON	02/05/2020
2		200 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		02/05/2020

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L'OREAL USA PRODUCTS, INC.		624244349	manufacture(49967-397) , pack(49967-397)