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

Garnier Ombrelle Ultra Light Advanced Broad Spectrum SPF 60 Sunscreen by

Drug Labeling and Warnings

Garnier Ombrelle Ultra Light Advanced Broad Spectrum SPF 60 Sunscreen 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 ingredient

Drometrizole trisiloxane 7%

Bemotrizinol 5%

Octisalate 5%

Octocrylene 5%

Avobenzone 3%

Homosalate 2%

Ensulizole 0.5%

Purpose 

Sunscreen

Warnings

For external use only

Do not use

on 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, call a poison control centre or get medical help 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 siwmming 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-sleeved shirts, pants, hats, and sunglasses. 

Inactive ingredients

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

Questions?

1 888-966-2735 

(9-Ombrel)

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-649
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DROMETRIZOLE TRISILOXANE (UNII: HC22845I1X) (DROMETRIZOLE TRISILOXANE - UNII:HC22845I1X)	DROMETRIZOLE TRISILOXANE	70 mg  in 1 mL
BEMOTRIZINOL (UNII: PWZ1720CBH) (BEMOTRIZINOL - UNII:PWZ1720CBH)	BEMOTRIZINOL	50 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
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	20 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)
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)
TROLAMINE (UNII: 9O3K93S3TK)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V)
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: 49967-649-01	1 in 1 CARTON	02/01/2023
1		50 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		02/01/2023

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L'OREAL USA PRODUCTS, INC		624244349	manufacture(49967-649)