Garnier Ombrelle 30 Complete Dry Mist SPF 30 Water Resistant 80 Minutes by L'OREAL USA PRODUCTS INC / L'OREAL USA, INC Drug Facts

Garnier Ombrelle 30 Complete Dry Mist SPF 30 Water Resistant 80 Minutes by

Drug Labeling and Warnings

Garnier Ombrelle 30 Complete Dry Mist SPF 30 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]

GARNIER OMBRELLE 30 COMPLETE DRY MIST SPF 30 WATER RESISTANT 80 MINUTES- avobenzone, homosalate, octisalate and octocrylene spray 
L'OREAL USA PRODUCTS INC

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Drug Facts

Active ingredients

Avobenzone 2.96%

Homosalate 8.78%

Octisalate 4.88%

Octocrylene 5.92%

Warnings

For external use only. Flammability Warning. Do not use in presence of open flame or spark. When using this product avoid contact witheyes. If contact occurs, rinse thoroughlly with water. Do not use on broken skin. Stop use and ask a doctor if rash occurs. Other warnings. Contents under pressure, do not place in hot water or near radiator, stoves or other sources of heat, do not puncture or incinerate container or store at temperatures over 50oC. Keep out of reach of children. If swallowed get medical help or contact a poison control center right away. 

Directions 

Adults and children over 6 months of age. 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 hand then apply to face. Do not apply in windy conditions and use in a well ventilated area, avoid inhaling or exposing others to spray. Reapply at least every 2 hours, after 80 minutes of swimming or sweating, right after towel drying. 

Others

butane, water, dicaprylyl ether, dimethicone, dicaprylyl carbonate, styrene/acrylates copolymer, PEG-30 dipolyhydroxystearate, methyl methacrylate crosspolymer, nylon-12, cyclohexasiloxane, menthyl lactate, polymethylsilsesquioxane, isododecane, phenoxyethanol, lauryl PEG/PPG-18/18 methicone, sodium chloride, caprylyl glycol, PEG-8 laurate, p-anisic acid, chlorphenesin, poly c10-30 alkyl acrylate, tocopherol, disteardimonium hectorite, disodium EDTA, dodecane, poloxamer 407, propylene carbonate

GARNIER OMBRELLE 30 COMPLETE DRY MIST SPF 30 WATER RESISTANT 80 MINUTES 
avobenzone, homosalate, octisalate and octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-255
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	29.6 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	87.8 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	48.8 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	59.2 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BUTANE (UNII: 6LV4FOR43R)
WATER (UNII: 059QF0KO0R)
DICAPRYLYL ETHER (UNII: 77JZM5516Z)
DIMETHICONE (UNII: 92RU3N3Y1O)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
NYLON-12 (UNII: 446U8J075B)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
ISODODECANE (UNII: A8289P68Y2)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PEG-8 LAURATE (UNII: 762O8IWA10)
p-ANISIC ACID (UNII: 4SB6Y7DMM3)
CHLORPHENESIN (UNII: I670DAL4SZ)
TOCOPHEROL (UNII: R0ZB2556P8)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
EDETATE DISODIUM (UNII: 7FLD91C86K)
DODECENE (UNII: WYE669F3GR)
POLOXAMER 407 (UNII: TUF2IVW3M2)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-255-01	142 mL in 1 CONTAINER; Type 0: Not a Combination Product	03/01/2014	03/31/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
export only		03/01/2014	03/31/2023

Labeler - L'OREAL USA PRODUCTS INC (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L'OREAL USA, INC		624244349	manufacture(49967-255) , pack(49967-255)

Revised: 2/2024

Document Id: ba34bfe3-33b1-4e29-9146-e60903ebd7c2

34390-5

Set id: 10b36e0c-977f-4d6d-a174-238c252189a0

Version: 3

Effective Time: 20240201