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

BB Brite 30 BS SPF30 by

Drug Labeling and Warnings

BB Brite 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 USE ON 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, GLYCERIN, ARBUTIN, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, PEG/PPG-18/18 DIMETHICONE, 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, PHYLLANTHUS EMBLICA FRUIT EXTRACT, ARCTOSTAPHYLOS UVA-URSI (BEARBERRY) LEAF EXTRACT, MORUS ALBA FRUIT EXTRACT, XANTHAN GUM, SODIUM BENZOATE, PHENOXYETHANOL, CAPRYLYL GLYCOL, ETHYLHEXYLGLYCERIN, HEXYLENE GLYCOL, MANNITOL, SODIUM CITRATE, LECITHIN, TRIETHOXYCAPRYLYLSILANE, FRUCTOSE, DIPROPYLENE GLYCOL, SALICYLIC ACID, SORBIC ACID MAY CONTAIN +/-, TITANIUM DIOXIDE (CI 77891), IRON OXIDES (CI 77491, CI 77492, CI 77499)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BB BRITE 30 BS SPF30 
zinc oxide and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62742-4247
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	8.5 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	6.8 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SQUALANE (UNII: GW89575KF9)
SANDALWOOD (UNII: 3641YW25N2)
ARTEMISIA VULGARIS ROOT (UNII: 32MP823R8S)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
XANTHIUM SIBIRICUM FRUIT (UNII: 3H333L84C2)
CYPERUS ROTUNDUS ROOT (UNII: 4B51SRR959)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TOCOPHEROL (UNII: R0ZB2556P8)
WHITE MULBERRY (UNII: MN25R0HH5A)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
ACETYL TETRAPEPTIDE-15 (UNII: 6K389LE0MV)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
LAMINARIA DIGITATA (UNII: 15E7C67EE8)
CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)
PHYLLANTHUS EMBLICA FRUIT (UNII: YLX4CW2576)
ARCTOSTAPHYLOS UVA-URSI LEAF (UNII: 3M5V3D1X36)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBIC ACID (UNII: X045WJ989B)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)
PHELLODENDRON AMURENSE BARK (UNII: PBG27B754G)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
FRUCTOSE (UNII: 6YSS42VSEV)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
WATER (UNII: 059QF0KO0R)
HYDROXYPROPYLCOCOATE PEG-8 DIMETHICONE (UNII: 8TE0BZU36S)
POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
GLYCERIN (UNII: PDC6A3C0OX)
ARBUTIN (UNII: C5INA23HXF)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE (UNII: X75PL53TZJ)
BARLEY (UNII: 5PWM7YLI7R)
ISOHEXADECANE (UNII: 918X1OUF1E)
SACCHAROMYCES LYSATE (UNII: R85W246Z1C)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ZINC PIDOLATE (UNII: C32PQ86DH4)
LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
MANNITOL (UNII: 3OWL53L36A)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SALICYLIC ACID (UNII: O414PZ4LPZ)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BETA CAROTENE (UNII: 01YAE03M7J)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)
APPLE PEEL (UNII: MA36MNW77O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62742-4247-2	1 in 1 CARTON	03/11/2024
1	NDC: 62742-4247-1	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	03/11/2024

Labeler - Allure Labs (926831603)

Registrant - Allure Labs (926831603)

Establishment
Name	Address	ID/FEI	Business Operations
Allure Labs		926831603	manufacture(62742-4247)