Label: BB AMBRE 30 BS SPF30- zinc oxide and titanium dioxide cream
- NDC Code(s): 62742-4252-1, 62742-4252-2
- Packager: Allure Labs
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 14, 2024
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
DIRECTIONS FOR SUNSCREEN USE: APPLY GENEROUSLY 15 MINUTES BEFORE SUN EXPOSURE. APPLY TO ALL SKIN EXPOSED BY THE SUN. CHILDREN UNDER 6 MONTHS OF AGE: ASK A DOCTOR. 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 SUN, ESPECIALLY FROM 10 A.M. - 2 P.M. WEAR LONG-SLEEVED SHIRTS, PANTS, HATS AND SUNGLASSES. REAPPLY AT LEAST EVERY 2 HOURS. USE A WATER RESISTANT SUNSCREEN IF SWIMMING OR SWEATING IMMEDIATELY AFTER TOWEL DRYING AT LEAST EVERY 2 HOURS.
- OTHER SAFETY INFORMATION
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INACTIVE INGREDIENT
INACTIVE INGREDIENTS: CYCLOPENTASILOXANE, WATER (AQUA), DIMETHICONE, HYDROXYPROPYLCOCOATE PEG-8 DIMETHICONE, POLYGLYCERYL-2 DIISOSTEARATE, POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE, DIMETHICONE/PEG-10/15 CROSSPOLYMER, STEARIC ACID, ALUMINUM HYDROXIDE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, PEG/PPG-18/18DIMETHICONE, TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE, SQUALANE, SANTALUM ALBUM (SANDALWOOD) EXTRACT, PHELLODENDRON AMURENSE BARK EXTRACT, HORDEUM DISTICHON (BARLEY) EXTRACT, CYCLOHEXASILOXANE, ISOHEXADECANE, SACCHAROMYCES LYSATE EXTRACT, SODIUM HYALURONATE, LAMINARIA DIGITATA EXTRACT, ARTEMISIA VULGARIS EXTRACT, ZINC PCA, CENTELLA ASIATICA EXTRACT, OLEA EUROPAEA (OLIVE) LEAF EXTRACT, ACETYL TETRAPEPTIDE-15, XANTHIUM SIBIRICUM FRUIT EXTRACT, LONICERA JAPONICA FLOWER EXTRACT, CYPERUS ROTUNDUS ROOT EXTRACT, PHOSPHOLIPIDS, RETINYL PALMITATE, TOCOPHEROL, ASCORBYL PALMITATE, BETA-CAROTENE, MALUS DOMESTICA FRUIT CELL CULTURE EXTRACT, VITIS VINIFERA (GRAPE) FRUIT CELL EXTRACT, XANTHAN GUM, GLYCERIN, PHENOXYETHANOL, CAPRYLYL GLYCOL, ETHYLHEXYLGLYCERIN, HEXYLENE GLYCOL, ISOMALT, SODIUM BENZOATE, MANNITOL, SODIUM CITRATE, LECITHIN, TRIETHOXYCAPRYLYLSILANE, FRUCTOSE, DIPROPYLENE GLYCOL, SALICYLIC ACID, SORBIC ACID, ALUMINA, MAGNESIUM OXIDE MAY CONTAIN +/- TITANIUM DIOXIDE (CI 77891), IRON OXIDES (CI 77491, CI 77492, CI 77499)
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BB AMBRE 30 BS SPF30
zinc oxide and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62742-4252 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 6.8 g in 100 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 8.5 g in 100 g Inactive Ingredients Ingredient Name Strength LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y) TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE (UNII: X75PL53TZJ) SANDALWOOD (UNII: 3641YW25N2) WATER (UNII: 059QF0KO0R) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) DIPROPYLENE GLYCOL (UNII: E107L85C40) ALUMINUM OXIDE (UNII: LMI26O6933) PHELLODENDRON AMURENSE BARK (UNII: PBG27B754G) BARLEY (UNII: 5PWM7YLI7R) CYCLOMETHICONE 6 (UNII: XHK3U310BA) SACCHAROMYCES LYSATE (UNII: R85W246Z1C) ARTEMISIA VULGARIS ROOT (UNII: 32MP823R8S) CYPERUS ROTUNDUS ROOT (UNII: 4B51SRR959) TOCOPHEROL (UNII: R0ZB2556P8) SODIUM CITRATE (UNII: 1Q73Q2JULR) MAGNESIUM OXIDE (UNII: 3A3U0GI71G) STEARIC ACID (UNII: 4ELV7Z65AP) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) GLYCERIN (UNII: PDC6A3C0OX) FERRIC OXIDE RED (UNII: 1K09F3G675) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DIMETHICONE (UNII: 92RU3N3Y1O) OLEA EUROPAEA LEAF (UNII: MJ95C3OH47) OMEGA-3 FATTY ACIDS (UNII: 71M78END5S) ASCORBYL PALMITATE (UNII: QN83US2B0N) PHENOXYETHANOL (UNII: HIE492ZZ3T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) HEXYLENE GLYCOL (UNII: KEH0A3F75J) SODIUM BENZOATE (UNII: OJ245FE5EU) MANNITOL (UNII: 3OWL53L36A) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) ISOHEXADECANE (UNII: 918X1OUF1E) LAMINARIA DIGITATA (UNII: 15E7C67EE8) CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J) ZINC PIDOLATE (UNII: C32PQ86DH4) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) APPLE (UNII: B423VGH5S9) HYDROXYPROPYLCOCOATE PEG-8 DIMETHICONE (UNII: 8TE0BZU36S) POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P) HYALURONATE SODIUM (UNII: YSE9PPT4TH) SORBIC ACID (UNII: X045WJ989B) WINE GRAPE (UNII: 3GOV20705G) XANTHAN GUM (UNII: TTV12P4NEE) ISOMALT (UNII: S870P55O2W) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) FRUCTOSE (UNII: 6YSS42VSEV) SQUALANE (UNII: GW89575KF9) POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q) ACETYL TETRAPEPTIDE-15 (UNII: 6K389LE0MV) XANTHIUM SIBIRICUM FRUIT (UNII: 3H333L84C2) BETA CAROTENE (UNII: 01YAE03M7J) SALICYLIC ACID (UNII: O414PZ4LPZ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62742-4252-2 1 in 1 CARTON 03/14/2024 1 NDC:62742-4252-1 20 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 03/14/2024 Labeler - Allure Labs (926831603) Registrant - Allure Labs (926831603) Establishment Name Address ID/FEI Business Operations Allure Labs 926831603 manufacture(62742-4252)