PAUL AND JOE PROTECTIVE FOUNDATION PRIMER UV- octinoxate, titanium dioxide, and zinc oxide emulsion 
Albion Co., Ltd

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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PAUL & JOE® PROTECTIVE FOUNDATION PRIMER UV

Drug Facts

Active ingredientsPurpose
OCTINOXATE 3.0%Sunscreen
TITANIUM DIOXIDE 5.9%Sunscreen
ZINC OXIDE 8.1%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

  • apply liberally and evenly 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a water resistant sunscreen if swimming or sweating
  • 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 the sun, especially from 10 a.m. – 2 p.m.
    • wear long-sleeve shirts, pants, hats, and sunglasses
  • children under 6 months: Ask a doctor

Other information

  • protect this product from excessive heat and direct sun

Inactive ingredients

WATER (AQUA) • CYCLOMETHICONE • PEG • 9 POLYDIMETHYLSILOXYETHYL DIMETHICONE • ALCOHOL • DIPROPYLENE GLYCOL • DIMETHICONE • ISOTRIDECYL ISONONANOATE • 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 • CELLULOSE • DIMETHICONE/METHICONE COPOLYMER • DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER • DISTEARDIMONIUM HECTORITE • LAURYL POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE • PEG/PPG-19/19 DIMETHICONE • POLYGLYCERYL-2 ISOSTEARATE • POLYSORBATE 80 • SILICA • SODIUM CHLORIDE • SORBITAN SESQUIOLEATE • STEARIC ACID • METHYLPARABEN • FRAGRANCE (PARFUM) • [MAY CONTAIN(+/-) • IRON OXIDES (CI 77491) • IRON OXIDES (CI 77492) • IRON OXIDES (77499) • MICA • ULTRAMARINES (CI 77007)]

PRINCIPAL DISPLAY PANEL - 26.9 ml Tube Carton

PAUL & JOE®

PROTECTIVE
FOUNDATION PRIMER UV

SUNSCREEN
BROAD SPECTRUM
SPF40 PA++

26.9 ml e Net Wt. 1 oz.

Principal Display Panel - 26.9 ml Tube Carton
PAUL AND JOE PROTECTIVE FOUNDATION PRIMER UV 
octinoxate, titanium dioxide, and zinc oxide emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42908-201
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE30 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE59 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE81 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
ALCOHOL (UNII: 3K9958V90M)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ISOTRIDECYL ISONONANOATE (UNII: WEF51750MT)  
ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)  
CITRUS SINENSIS FLOWER OIL (UNII: AJ56JP5TFP)  
LILIUM CANDIDUM BULB (UNII: AHG15J8AM0)  
MENTHA PIPERITA LEAF (UNII: A389O33LX6)  
RUSCUS ACULEATUS ROOT (UNII: ZW12V95I1Q)  
JOJOBA OIL (UNII: 724GKU717M)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
TOCOPHEROL (UNII: R0ZB2556P8)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)  
POLYGLYCERYL-2 MONOISOSTEARATE (UNII: 7B8OE71MQC)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
MICA (UNII: V8A1AW0880)  
ULTRAMARINE BLUE (UNII: I39WR998BI)  
Product Characteristics
ColorBROWN (White beige) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42908-201-011 in 1 BOX02/01/200808/31/2016
126.9 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35202/01/200808/31/2016
Labeler - Albion Co., Ltd (690658398)

Revised: 6/2016
 
Albion Co., Ltd