ANTIOXIDANT PRIMER- titanium dioxide and zinc oxide cream

Antioxidant Primer by

Drug Labeling and Warnings

Antioxidant Primer by is a Otc medication manufactured, distributed, or labeled by Bare Escentuals Beauty Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	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 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 10am to 2 pm, wear long-sleeve shirts, pants, hats, and sunglasses.

Inactive Ingredients

Cyclopentasiloxane, dimethicone crosspolymer, dimethicone, styrene/acrylates copolymer, hexyl laurate, PEG 10 dimethicone, polyglycerol 4 isostearate, stearic acid, alumina, silica, topcopherol, magnesium silicate, panthenol, glycyrrhiza glaba (licorice) root extract, aloe bardenesis leaf extract, stearyl triethoxysilane, tetrahexyldecyl ascorbate, magnesium ascorbyl phosphate, retinyl retinoate, cyclodextrin. May contain: titanium dioxide and iron oxides.

Other information

Protect this product from excessive heat and direct sun

Questions or comments?

Call toll free 1-888-795-4747

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Bare Escentuals
MADE IN USA
Distr. By Bare Escentuals Beauty Inc., San Francisco CA 94104 USA
London W10 3QB

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton

bareMinerals®

PRIME
TIME™

ANTIOXIDANT
FOUNDATION
PRIMER

broad spectrum
SPF 30

TINTED

30 ml / 1 fl. oz.

INGREDIENTS AND APPEARANCE

ANTIOXIDANT PRIMER 
titanium dioxide and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 98132-184
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	26 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	62 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM OXIDE (UNII: LMI26O6933)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TOCOPHEROL (UNII: R0ZB2556P8)
MAGNESIUM SILICATE (UNII: 9B9691B2N9)
PANTHENOL (UNII: WV9CM0O67Z)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
STEARYL TRIETHOXYSILANE (UNII: 1VN9P25L8H)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
RETINYL RETINOATE (UNII: 5AT5X9J439)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 98132-184-09	1 in 1 CARTON
1		30 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/31/2013

Labeler - Bare Escentuals Beauty Inc. (087008363)