Label: LBEL DIVINE DOUBLE USE COMPACT SPF 15 GOLD DELUXE EDITION OBSCURE 8-9- zinc oxide, titantium dioxide, octinoxate powder
- NDC Code(s): 14141-206-01
- Packager: Bel Star S.A. (Colombia)
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated July 29, 2022
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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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
- OTHER SAFETY INFORMATION
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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, linalool, hydroxycitronellal, citronellol, geraniol, limonene, alpha-isomethyl ionone, May contain: Iron oxides, titanium dioxide
- Obscure 8-9
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INGREDIENTS AND APPEARANCE
LBEL DIVINE DOUBLE USE COMPACT SPF 15 GOLD DELUXE EDITION OBSCURE 8-9
zinc oxide, titantium dioxide, octinoxate powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14141-206 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 HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9) .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) LINALOOL, (+/-)- (UNII: D81QY6I88E) 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:14141-206-01 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 M020 11/12/2020 Labeler - Bel Star S.A. (Colombia) (880160197) Establishment Name Address ID/FEI Business Operations Bel Star S.A. (Colombia) 880160197 manufacture(14141-206)
