LBEL DIVINE DOUBLE USE COMPACT SPF 15 GOLD DELUXE EDITION OBSCURE 8-9- zinc oxide, titantium dioxide, octinoxate powder

LBEL DIVINE Double Use compact SPF 15 gold deluxe edition Obscure 8-9 by

Drug Labeling and Warnings

LBEL DIVINE Double Use compact SPF 15 gold deluxe edition Obscure 8-9 by is a Otc medication manufactured, distributed, or labeled by Ventura International LTD, Bel Star S.A. (Colombia). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients Purpose

Octinoxate 3.00% Sunscreen

Titanium Dioxide 6.24% Sunscreen

Zinc Oxide 4.90 % Sunscreen

PURPOSE

Uses:

Helps prevent Sunburn

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help, or contact a Poison Control Center right away.

INDICATIONS & USAGE

Stop use and ask a doctor if rash occurs.

WARNINGS

Warnings:Skin Cancer / Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

For external use only
Do not use on damaged or broken skin
When using this product, keep out of eyes. Rinse with water to remove.

DOSAGE & ADMINISTRATION

Directions:

Apply liberally and evenly 15 minutes before sun exposure.
Reapply at least every 2 hours
Use a water resistant sunscreen if swimming or sweating
Children under 6 months of age: Ask a doctor

OTHER SAFETY INFORMATION

Other information:

Protect the product in this container from excessive heat and direct sun

INACTIVE INGREDIENT

Inactive ingredients: Mica, polymethylsilsesquioxane, hdi/trimethylol hexyllactone crosspolymer, dimethicone, magnesium stearate, trimethylsiloxysilicate, isostearyl neopentanoate, hydrogen dimethicone, tocopheryl acetate, phenoxyethanol, alumina, triethoxycaprylylsilane, fragrance, caprylyl glycol, ceramide np, chlorphenesin, butylphenyl methylpropional, hydroxycitronellal, citronellol, geraniol, limonene, alpha-isomethyl ionone, May contain: Iron oxides, titanium dioxide

Obscure 8-9

L'BEL

Divine

Polvos Compactos doble uso FPS 15 edicion de lujo dorado

Double use compact SPF 15 gold deluxe edition

Tone: Obscure 8-9

Net. Wt. 0.35 oz (10g)

INGREDIENTS AND APPEARANCE

LBEL DIVINE DOUBLE USE COMPACT SPF 15 GOLD DELUXE EDITION OBSCURE 8-9 
zinc oxide, titantium dioxide, octinoxate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-280
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	6.24 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	4.9 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
FERRIC OXIDE RED (UNII: 1K09F3G675)
GERANIOL (UNII: L837108USY)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
CHLORPHENESIN (UNII: I670DAL4SZ)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALUMINUM OXIDE (UNII: LMI26O6933)
MAGNESIUM STEARATE (UNII: 70097M6I30)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
MICA (UNII: V8A1AW0880)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CERAMIDE NP (UNII: 4370DF050B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-280-01	10 g in 1 BOTTLE; Type 0: Not a Combination Product	11/12/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	11/12/2020

Labeler - Ventura International LTD (603192787)

Establishment
Name	Address	ID/FEI	Business Operations
Bel Star S.A. (Colombia)		880160197	manufacture(14783-280)