GARNIER OMBRELLE ULTRA LIGHT ADVANCED 60 FACE SUNSCREEN- drometrizole trisiloxane, octocrylene, bemotrizinol, octisalate, avobenzone, homosalate and ensulizole lotion

Garnier Ombrelle Ultra Light Advanced 60 Face Sunscreen by

Drug Labeling and Warnings

Garnier Ombrelle Ultra Light Advanced 60 Face Sunscreen by is a Otc medication manufactured, distributed, or labeled by L'OREAL USA PRODUCTS INC, Dimensional Merchandising Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

DROMETRIZOLE TRISILOXANE 7%
OCTOCRYLENE 5%
BEMOTRIZINOL 5%
OCTISALATE 5%
AVOBENZONE 3%
HOMOSALATE 2%
ENSULIZOLE 0.50%

Warnings

For external use only. Do not use on broken skin. When using this product avoid contact witheyes. If contact occurs, rinse thoroughlly 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 adolescents 12 to 17 years.
Apply generously and evenly 15 minutes before sun exposure. Reapply at least every 2 hours. Reapply after 80 minutes of swimming or sweating. Reapply immediately after towel drying. 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 Broad Spectrum SPF 15 or higher sunscreen. Limit time in the sun, especially from 10 a.m. – 2 p.m. Wear long-sleeve shirts, pants, hats and sunglasses.

Inactive ingredients

wwater, alcohol denat., silica, isopropyl myristate, glycerin, diisopropyl sebacate, propanediol, c12-22 alkyl acrylate/hydroxyethylacrylate copolymer, perlite, tocopherol, triethanolamine, caprylyl glycol, hydroxyethylcellulose, acrylates/c10-30 alkyl acrylate crosspolymer, pentylene glycol, butylene glycol, citric acid

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GARNIER OMBRELLE ULTRA LIGHT ADVANCED 60 FACE SUNSCREEN 
drometrizole trisiloxane, octocrylene, bemotrizinol, octisalate, avobenzone, homosalate and ensulizole lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-046
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
DROMETRIZOLE TRISILOXANE (UNII: HC22845I1X) (DROMETRIZOLE TRISILOXANE - UNII:HC22845I1X)	DROMETRIZOLE TRISILOXANE	70 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	20 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	50 mg  in 1 mL
BEMOTRIZINOL (UNII: PWZ1720CBH) (BEMOTRIZINOL - UNII:PWZ1720CBH)	BEMOTRIZINOL	50 mg  in 1 mL
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
GLYCERIN (UNII: PDC6A3C0OX)
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)
PROPANEDIOL (UNII: 5965N8W85T)
PERLITE (UNII: 0SG101ZGK9)
TOCOPHEROL (UNII: R0ZB2556P8)
TROLAMINE (UNII: 9O3K93S3TK)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-046-01	1 in 1 CARTON	01/01/2023
1		50 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		01/01/2023

Labeler - L'OREAL USA PRODUCTS INC (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
Dimensional Merchandising Inc.		076693183	manufacture(49967-046) , pack(49967-046)