ANTIOXIDANT PRIMER- titanium dioxide and zinc oxide cream 
Bare Escentuals Beauty Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Antioxidant Primer

Drug Facts

Active IngredientsPurpose
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

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.

Principal Display Panel - 30 ml Bottle Carton
ANTIOXIDANT PRIMER 
titanium dioxide and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:98132-184
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide26 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide62 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:98132-184-091 in 1 CARTON
130 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35203/31/2013
Labeler - Bare Escentuals Beauty Inc. (087008363)

Revised: 3/2013
Document Id: 13e5d3d9-928d-4e92-a382-7e084f48f85c
Set id: 78d8041e-df86-43a8-83c5-163cd9382426
Version: 1
Effective Time: 20130304
 
Bare Escentuals Beauty Inc.