BAREMINERALS PRIME TIME BB PRIMER-CREAM BROAD SPECTRUM SPF 30 LIGHT- titanium dioxide and zinc oxide cream BAREMINERALS PRIME TIME BB PRIMER-CREAM BROAD SPECTRUM SPF 30 MEDIUM- titanium dioxide and zinc oxide cream

bareMinerals Prime Time BB Primer-Cream Broad Spectrum SPF 30 by

Drug Labeling and Warnings

bareMinerals Prime Time BB Primer-Cream Broad Spectrum SPF 30 by is a Otc medication manufactured, distributed, or labeled by Orveon Global US LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient(s)	Purpose
Titanium dioxide 2.6%	Sunscreen
Zinc oxide 6.2%	Sunscreen

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

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.

Stop use and ask a doctor if rash occurs

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

Directions

For sunscreen use:

• apply liberally 15 minutes before sun exposure
• use a water resistant sunscreen if swimming or sweating
• reapply at least every 2 hours
• children under 6 months: 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 of 15 or higher and other sun protection measures including:
• limit time in the sun, especially from 10 a.m. – 2 p.m.
• wear long-sleeve shirts, pants, hats, and sunglasses

Inactive ingredients

cyclopentasiloxane, dimethicone crosspolymer, hydrogenated polydecene, dimethicone, styrene/acrylates copolymer, hexyl laurate, PEG-10 dimethicone, polyglyceryl-4 isostearate, stearic acid, alumina, silica, tocopherol, magnesium silicate, panthenol, glycyrrhiza glabra (licorice) root extract, aloe barbadensis leaf extract, stearyl triethoxysilane, tetrahexyldecyl ascorbate, magnesium ascorbyl phosphate, retinyl retinoate, cyclodextrin. may contain: titanium dioxide, iron oxides.

Other information

Protect this product from excessive heat and direct sun

Questions or comments?

Call toll free 1-888-795-4747

SPL UNCLASSIFIED SECTION

Dist. by Bare Escentuals Beauty, Inc.
SF, CA 94105 USA

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton - Light

bareMinerals ®

PRIME TIME™

BB PRIMER-CREAM
BROAD SPECTRUM SPF 30

30 ml / 1 fl. oz.

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton - Medium

bareMinerals ®

PRIME TIME™

BB PRIMER-CREAM
BROAD SPECTRUM SPF 30

30 ml / 1 fl. oz.

INGREDIENTS AND APPEARANCE

BAREMINERALS PRIME TIME BB PRIMER-CREAM BROAD SPECTRUM SPF 30  LIGHT
titanium dioxide and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 98132-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	780 mg  in 30 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	1860 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)
DIMETHICONE (UNII: 92RU3N3Y1O)
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
FERRIC OXIDE RED (UNII: 1K09F3G675)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM OXIDE (UNII: LMI26O6933)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TOCOPHEROL (UNII: R0ZB2556P8)
PANTHENOL (UNII: WV9CM0O67Z)
MAGNESIUM SILICATE (UNII: 9B9691B2N9)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
STEARYL TRIETHOXYSILANE (UNII: 1VN9P25L8H)
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
RETINYL RETINOATE (UNII: 5AT5X9J439)
CYCLODEXTRINS (UNII: 7E6SK9QDT8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 98132-004-01	1 in 1 CARTON	07/30/2021
1		30 mL 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	07/30/2021

BAREMINERALS PRIME TIME BB PRIMER-CREAM BROAD SPECTRUM SPF 30  MEDIUM
titanium dioxide and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 98132-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	781 mg  in 31 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	1861 mg  in 31 mL

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)
DIMETHICONE (UNII: 92RU3N3Y1O)
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)
FERRIC OXIDE RED (UNII: 1K09F3G675)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
STEARIC ACID (UNII: 4ELV7Z65AP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
ALUMINUM OXIDE (UNII: LMI26O6933)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TOCOPHEROL (UNII: R0ZB2556P8)
PANTHENOL (UNII: WV9CM0O67Z)
MAGNESIUM SILICATE (UNII: 9B9691B2N9)
STEARYL TRIETHOXYSILANE (UNII: 1VN9P25L8H)
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
RETINYL RETINOATE (UNII: 5AT5X9J439)
CYCLODEXTRINS (UNII: 7E6SK9QDT8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 98132-003-01	1 in 1 CARTON	07/30/2021
1		30 mL 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	07/30/2021

Labeler - Orveon Global US LLC (118344494)