LOREAL PARIS OMBRELLE SPF 30 COMPLETE WATER RESISTANT- avobenzone, octocrylene, terephthalylidene dicamphor sulfonic acid and titanium dioxide lotion

LOreal Paris Ombrelle SPF 30 Complete Water Resistant by

Drug Labeling and Warnings

LOreal Paris Ombrelle SPF 30 Complete Water Resistant 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%

Octocrylene 10%

Terephthalylidene Dicamphor Sulfonic Acid 1%

Titanium Dioxide 2.2%

Warnings

For external use only. Discontinue use if irritation develops or increases. If irritation persists, consult a doctor. Avoid contact with eyes. If contact occurs, rinse thoroughly with water. Keep out of reach of children. Before use on children under 6 months, consult a doctor. Do not expose babies and young children directly to the sun. Avoid contact with textiles.

Directions

Apply generously (a palmful for an adult body) 15 to 30 minutes before sun exposure. Reapply every 2 hours or as needed after swimming, washing, towel drying or perspiring heavily.

Inactive ingredients

water, propylene glycol, glycerin, cyclopentasiloxane, isopropyl palmitate, stearic acid, triethanolamine, VP/eicosene copolymer, dimethicone, panthenol, phenoxyethanol, PEG-100 stearate, glyceryl stearate, methylparaben, aluminum hydroxide, acrylates/C10-30 alkyl acrylate crosspolymer, chlorphenesin, tocopherol, disodium EDTA, propylparaben, xanthan gum

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LOREAL PARIS OMBRELLE SPF 30 COMPLETE WATER RESISTANT 
avobenzone, octocrylene, terephthalylidene dicamphor sulfonic acid and titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-000
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
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 mL
ECAMSULE (UNII: M94R1PM439) (ECAMSULE - UNII:M94R1PM439)	ECAMSULE	10 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	22 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
STEARIC ACID (UNII: 4ELV7Z65AP)
TROLAMINE (UNII: 9O3K93S3TK)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
DIMETHICONE (UNII: 92RU3N3Y1O)
PANTHENOL (UNII: WV9CM0O67Z)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PEG-100 STEARATE (UNII: YD01N1999R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
METHYLPARABEN (UNII: A2I8C7HI9T)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
CHLORPHENESIN (UNII: I670DAL4SZ)
TOCOPHEROL (UNII: R0ZB2556P8)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-000-01	1 in 1 CARTON	01/01/2017
1		120 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 49967-000-02	1 in 1 CARTON	01/01/2017
2		240 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		01/01/2017

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L'OREAL USA, INC.		624244349	manufacture(49967-000) , pack(49967-000)