GARNIER OMBRELLE ULTRA LIGHT ADVANCED 60 FACE SUNSCREEN- drometrizole trisiloxane, octocrylene, bemotrizinol, octisalate, avobenzone, homosalate and ensulizole lotion 
L'OREAL USA PRODUCTS INC

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Drug Facts

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

image of a carton

image of a carton
GARNIER OMBRELLE ULTRA LIGHT ADVANCED 60 FACE SUNSCREEN 
drometrizole trisiloxane, octocrylene, bemotrizinol, octisalate, avobenzone, homosalate and ensulizole lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-046
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
DROMETRIZOLE TRISILOXANE (UNII: HC22845I1X) (DROMETRIZOLE TRISILOXANE - UNII:HC22845I1X) DROMETRIZOLE TRISILOXANE70 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE20 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE50 mg  in 1 mL
BEMOTRIZINOL (UNII: PWZ1720CBH) (BEMOTRIZINOL - UNII:PWZ1720CBH) BEMOTRIZINOL50 mg  in 1 mL
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49967-046-011 in 1 CARTON01/01/2023
150 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
export only01/01/2023
Labeler - L'OREAL USA PRODUCTS INC (002136794)
Establishment
NameAddressID/FEIBusiness Operations
Dimensional Merchandising Inc.076693183manufacture(49967-046) , pack(49967-046)

Revised: 12/2023
Document Id: 871dba41-60bf-409e-b2c6-1d7061ec6236
Set id: 3db5cba4-fc32-4841-8d7a-27c36f6b6d90
Version: 2
Effective Time: 20231231
 
L'OREAL USA PRODUCTS INC