BB AMBRE 30 BS SPF30- zinc oxide and titanium dioxide cream

BB Ambre 30 BS SPF30 by

Drug Labeling and Warnings

BB Ambre 30 BS SPF30 by is a Otc medication manufactured, distributed, or labeled by Allure Labs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENTS

ZINC OXIDE 8.5%

TITANIUM DIOXIDE 6.8%

PURPOSE

PURPOSE:

SUNSCREEN

INDICATIONS & USAGE

USES: HELPS PREVENT SUNBURN. IF USED AS DIRECTED WITH OTHER SUN PROTECTION MEASURES (SEE DIRECTIONS), DECREASES THE RISK OF SKIN CANCER AND EARLY SKIN AGING CAUSED BY THE SUN.

WARNINGS

WARNINGS FOR EXTERNAL USE ONLY

DO NOT USE

DO NOT USEON DAMAGED OR BROKEN SKIN

WHEN USING

WHEN USING THIS PRODUCT KEEP OUT OF EYES. IF CONTACT OCCURS, RINSE WITH WATER. DISCONTINUE USE IF IRRITATION OR REDNESS OCCURS.

STOP USE

STOP USE AND ASK A DOCTOR IF SEVERE IRRITATION OCCURS

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF THE REACH OF CHILDREN IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

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

OTHER INFORMATION: PROTECT THE PRODUCT IN THIS CONTAINER FROM EXCESSIVE HEAT AND DIRECT SUN.

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

INGREDIENTS AND APPEARANCE

BB AMBRE 30 BS SPF30 
zinc oxide and titanium dioxide cream

Product 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)