PAUL and JOE PROTECTIVE FOUNDATION PRIMER UV 02

Dosage form: lotion
Ingredients: OCTINOXATE 30mg in 1mL, TITANIUM DIOXIDE 60mg in 1mL, ZINC OXIDE 81mg in 1mL
Labeler: Albion Co., Ltd.
NDC Code: 42908-003

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.

PAUL & JOE®
PROTECTIVE
FOUNDATION PRIMER UV 02

Drug Facts

Active ingredientsPurpose
OCTINOXATE 3.0%Sunscreen
TITANIUM DIOXIDE 6.0%Sunscreen
ZINC OXIDE 8.1%Sunscreen

Uses
  • Helps prevent sunburn.
  • Higher SPF gives more sunburn protection.
  • Provides high protection against sunburn.

Warnings

For external use only.

When using this product
  • keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if
  • rash or irritation develops and lasts.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions
  • Before using foundation, place an appropriate amount on fingertips or palm and apply evenly all over face.
  • Apply evenly before sun exposure and as needed.
  • Children under 6 months of age:ask a doctor.

Inactive ingredients

WATER (AQUA), CYCLOMETHICONE, DIMETHICONE, DIPROPYLENE GLYCOL, ALCOHOL, PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, CETYL ETHYLHEXANOATE, VINYL DIMETHICONEMETHICONE SILSESQUIOXANE CROSSPOLYMER, ASCORBYL TETRAISOPALMITATE, CITRUS AURANTIUM DULCIS (ORANGE) FLOWER WATER, LILIUM CANDIDUM BULB EXTRACT, MENTHA PIPERITA (PEPPERMINT) LEAF EXTRACT, RUSCUS ACULEATUS ROOT EXTRACT, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL, SODIUM HYALURONATE, TOCOPHEROL, ACRYLATES/DIMETHICONE COPOLYMER, ALUMINUM HYDROXIDE, BHT, BUTYLENE GLYCOL, DIMETHICONEMETHICONE COPOLYMER, LAURYLPOLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE, METHYLSILANOL TRI-PEG-8 GLYCERYL COCOATE, MICROCRYSTALLINE CELLULOSE, PEG-7 GLYCERYL COCOATE, PEG/PPG-19/19 DIMETHICONE, POLYQUATERNIUM-7, SODIUM CHLORIDE, STEARIC ACID, TALC, METHYLPARABEN, FRAGRANCE (PARFUM), MAY CONTAIN (+/-) IRON OXIDES (CI 77491), IRON OXIDES (CI 77492), IRON OXIDES (CI 77499), MICA, ULTRAMARINES (CI 77007)

Dist. Albion Cosmetics (America) Inc.
New York

Technolabo Co., Ltd.
Ginza Tokyo 104-0061

Made in Japan

PRINCIPAL DISPLAY PANEL - 26.9 ml Carton

PAUL & JOE®

PROTECTIVE
FOUNDATION PRIMER UV 02

26.9 ml e Net Wt. 1 oz.

PAUL AND JOE PROTECTIVE FOUNDATION PRIMER UV 02 
octinoxate, titanium dioxide and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42908-003
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE30 mg  in 1 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE60 mg  in 1 mL
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE81 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
CYCLOMETHICONE 
DIMETHICONE 
DIPROPYLENE GLYCOL 
ALCOHOL 
LILIUM CANDIDUM BULB 
PEPPERMINT 
RUSCUS ACULEATUS ROOT 
JOJOBA OIL 
HYALURONATE SODIUM 
ALUMINUM HYDROXIDE 
BUTYLATED HYDROXYTOLUENE 
BUTYLENE GLYCOL 
CELLULOSE, MICROCRYSTALLINE 
SODIUM CHLORIDE 
STEARIC ACID 
TALC 
METHYLPARABEN 
Packaging
#Item CodePackage Description
1NDC:42908-003-021 TUBE in 1 CARTON
126.9 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/01/2010
Labeler - Albion Co., Ltd. (690658398)

Revised: 06/2013
 
Albion Co., Ltd.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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