Paul and joe silky smooth foundation uv 301 emulsion

Spl unclassified section

Drug Facts

Otc - active ingredient section

Otc - purpose section

Active ingredients Purpose
OCTINOXATE 5.00% Sunscreen
TITANIUM DIOXIDE 11.51% 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

Otc - do not use section

Do not useon damaged or broken skin

Otc - when using section

When using this productkeep out of eyes. Rinse with water to remove.

Otc - stop use section

Stop use and ask a doctor ifrash occurs

Otc - keep out of reach of children section

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 METHYL TRIMETHICONE ALCOHOL DIPROPYLENE GLYCOL VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER LAUROYL LYSINE PHENYL TRIMETHICONE POLYETHYLENE TALC CITRUS AURANTIUM DULCIS (ORANGE) FLOWER WATER GARDENIA FLORIDA FRUIT EXTRACT LILIUM CANDIDUM BULB EXTRACT LONICERA JAPONICA (HONEYSUCKLE) FLOWER EXTRACT MENTHA PIPERITA (PEPPERMINT) LEAF EXTRACT SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL SODIUM ACETYLATED HYALURONATE TOCOPHEROL ALUMINUM HYDROXIDE BHT BUTYLENE GLYCOL DIMETHICONE DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE/HEXASTEARATE/HEXAROSINATE HYDRATED SILICA ISOTRIDECYL ISONONANOATE LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE LAURYL POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE LECITHIN MICROCRYSTALLINE CELLULOSE PEG-9 DIMETHICONE PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE SODIUM CHLORIDE TRIETHOXYCAPRYLYLSILANE TRIETHYLHEXANOIN ZINC LAURATE METHYLPARABEN FRAGRANCE (PARFUM) [MAY CONTAIN(+/-) IRON OXIDES (CI 77491) IRON OXIDES (CI 77492) IRON OXIDES (CI 77499) MICA]

Ingredients and appearance - Product information

Paul and joe silky smooth foundation uv 301 emulsion- Octinoxate and titanium dioxide

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 42908-076
Route of Administration Topical

Active Ingredient/Active Moiety

Ingredient Name Strength
Octinoxate ( UNII: 4Y5P7MUD51)( Octinoxate - UNII: 4Y5P7MUD51 ) 50 mgin 1 mL
Titanium dioxide ( UNII: 15FIX9V2JP)( Titanium dioxide - UNII: 15FIX9V2JP ) 115.1 mgin 1 mL

Inactive Ingredients

Ingredient Name Code
Water ( UNII: 059QF0KO0R)
Cyclomethicone ( UNII: NMQ347994Z)
Methyl trimethicone ( UNII: S73ZQI0GXM)
Alcohol ( UNII: 3K9958V90M)
Dipropylene glycol ( UNII: E107L85C40)
Lauroyl lysine ( UNII: 113171Q70B)
Phenyl trimethicone ( UNII: DR0K5NOJ4R)
High density polyethylene ( UNII: UG00KM4WR7)
Talc ( UNII: 7SEV7J4R1U)
Citrus sinensis flower oil ( UNII: AJ56JP5TFP)
Gardenia jasminoides fruit ( UNII: 7CTH8MD549)
Lilium candidum bulb ( UNII: AHG15J8AM0)
Lonicera japonica flower ( UNII: 4465L2WS4Y)
Mentha piperita leaf ( UNII: A389O33LX6)
Jojoba oil ( UNII: 724GKU717M)
Sodium acetylated hyaluronate ( UNII: WN66R7GL93)
Tocopherol ( UNII: R0ZB2556P8)
Aluminum hydroxide ( UNII: 5QB0T2IUN0)
Butylated hydroxytoluene ( UNII: 1P9D0Z171K)
Butylene glycol ( UNII: 3XUS85K0RA)
Dimethicone ( UNII: 92RU3N3Y1O)
Hydrated silica ( UNII: Y6O7T4G8P9)
Isotridecyl isononanoate ( UNII: WEF51750MT)
Lauryl peg-9 polydimethylsiloxyethyl dimethicone ( UNII: 25G622K2RA)
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Peg-9 dimethicone (400 cst) ( UNII: 9OZ27X065D)
Peg-9 polydimethylsiloxyethyl dimethicone ( UNII: TYP81E471F)
Sodium chloride ( UNII: 451W47IQ8X)
Triethoxycaprylylsilane ( UNII: LDC331P08E)
Triethylhexanoin ( UNII: 7K3W1BIU6K)
Zinc laurate ( UNII: 4YOP58Y695)
Methylparaben ( UNII: A2I8C7HI9T)
Ferric oxide red ( UNII: 1K09F3G675)
Ferric oxide yellow ( UNII: EX438O2MRT)
Ferrosoferric oxide ( UNII: XM0M87F357)
Mica ( UNII: V8A1AW0880)

Product Characteristics

Color BROWN (Beige)

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC MONOGRAPH NOT FINAL part352 USA

Labeler - Albion Co., Ltd( 690658398)

Principal display panel - 30 ml bottle carton

PAUL & JOE ®

SILKY SMOOTH
FOUNDATION UV

SUNSCREEN
BROAD SPECTRUM
SPF28 PA++

30 ml e 1 fl. oz.