GARNIER OMBRELLE ULTRA LIGHT ADVANCED BROAD SPECTRUM SPF 50 PLUS SUNSCREEN WATER RESISTANT 80 MINUTES- avobenzone, drometrizole trisiloxane, homosalate, octisalate and octocrylene spray

Garnier Ombrelle Ultra Light Advanced Broad Spectrum SPF 50 Plus Sunscreen Water Resistant 80 Minutes by

Drug Labeling and Warnings

Garnier Ombrelle Ultra Light Advanced Broad Spectrum SPF 50 Plus Sunscreen Water Resistant 80 Minutes by is a Otc medication manufactured, distributed, or labeled by L'OREAL USA PRODUCTS INC, L'OREAL USA, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

AVOBENZONE 3%
DROMETRIZOLE TRISILOXANE 0.5%
HOMOSALATE 15%
OCTISALATE 5%
OCTOCRYLENE 3%

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.
Other warnings Contents under pressure. Do not place in hot water or near radiators,
stoves or other sources of heat. Do not puncture or incinerate container or store
at temperatures over 50 °C.
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 Shake well before use Spray generously
and spread evenly by hand 15 minutes before sun exposure Hold container 10 to
15 cm from the skin to apply Do not spray directly onto face. Spray on hands, then
apply to face Do not apply in windy conditions Use in a well-ventilated area
Avoid inhaling or exposing others to spray 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 sunscreen with
a Broad-Spectrum SPF value of 15 or higher and other sun protection measures
including: limit time in the sun, especially from 11 a.m. – 3 p.m. ; and wear
long-sleeved shirts, pants, hats, and sunglasses.

Others

aqua/water, dimethicone, glycerin, butyloctyl salicylate, isopropyl lauroyl sarcosinate, styrene/acrylates copolymer, isotridecyl isononanoate, polyurethane-35, caprylyl methicone, octyldodecanol, phenoxyethanol, caprylyl glycol, sodium stearoyl glutamate,
polysorbate 61, glyceryl stearate, PEG-8 laurate, dimethiconol, octyldodecyl xyloside, PEG-12 dimethicone, p-anisic acid, stearyl alcohol, tocopherol, disodium EDTA, sodium dodecylbenzenesulfonate, methylpropanediol, phenylpropanol

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GARNIER OMBRELLE ULTRA LIGHT ADVANCED BROAD SPECTRUM SPF 50 PLUS SUNSCREEN WATER RESISTANT 80 MINUTES 
avobenzone, drometrizole trisiloxane, homosalate, octisalate and octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-696
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	5 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	150 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ISOPROPYL LAUROYL SARCOSINATE (UNII: LYR06W430J)
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)
SORBITAN TRISTEARATE (UNII: 6LUM696811)
ISOTRIDECYL ISONONANOATE (UNII: WEF51750MT)
POLYURETHANE-35 (NOT MORE THAN 1000 MPA.S AT 40%) (UNII: M50EV976QC)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
OCTYLDODECANOL (UNII: 461N1O614Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
POLYSORBATE 61 (UNII: X9E1MY2JQG)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-8 LAURATE (UNII: 762O8IWA10)
DIMETHICONOL (100000 CST) (UNII: OSA9UP217S)
OCTYLDODECYL XYLOSIDE (UNII: 8Z6VNR46QM)
PEG-12 DIMETHICONE (UNII: ZEL54N6W95)
P-ANISIC ACID (UNII: 4SB6Y7DMM3)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
TOCOPHEROL (UNII: R0ZB2556P8)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM DODECYLBENZENESULFONATE (UNII: 554127163Y)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
PHENYLPROPANOL (UNII: 0F897O3O4M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-696-01	122 mL in 1 CONTAINER; Type 0: Not a Combination Product	10/18/2021	09/30/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
export only		10/18/2021	09/30/2025

Labeler - L'OREAL USA PRODUCTS INC (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L'OREAL USA, INC		960317444	manufacture(49967-696)