Label: PAULAS CHOICE RESIST YOUTH EXTENDING DAILY HYDRATING FLUID SPF 50- avonbenzone, octinoxate, octisalate, octocrylene liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated January 6, 2022

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  • ACTIVE INGREDIENT

    Avonbenzone 2.0%

    Octinoxate 7.5%

    Octisalate 5.0%

    Octocrylene 2.0%

  • PURPOSE

    Sunscreen

  • WARNINGS

    Warnings

    For external use only.

  • DO NOT USE

    Do not use on damaged or broken skin.

  • WHEN USING

    When using this product, keep out of eyes. rinse with water to remove.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If product is swalllowed, get medical help or contact a Poison Control Center immediately.

  • INSTRUCTIONS FOR USE

    Directions

    Apply liberally 15 minutes before sun exposure. Use a water-resistant sunscreen if swimming or sweating. Reapply at least every two hours if skin is exposed to sun.

    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 broad-spectrum sunscreen rated SPF 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 of age: ask a doctor
  • OTHER SAFETY INFORMATION

    Protect this product from excessive heat and direct sun. You may report serious adverse reactions to 705 5th Avenue South, Suite 200, Seattle, WA 98104

  • INACTIVE INGREDIENT

    Water, Glycerin, Silica, Dimethicone, Tocopherol, Chamomilla Recutita (Matricaria) Flower Extract, Vitis Vinifera (Grape) Seed Extract, Camellia Sinensis (Green Tea) Leaf Extract, Camellia Oleifera (Green Tea) Leaf Extract, Peucedanum Graveolens (Dill) Extract, Sambucus Nigra (Black Elderberry) Fruit Extract, Avena Sativa (Oat) Bran Extract, Punica Granatum (Pomegranate) Extract, Lycium Barbarum (Goji) Fruit Extract, Hydrogenated Lecithin, Titanium Dioxide, Dimethicone/Vinyl Dimethicone Crosspolymer, Diethylhexyl Syringylidenemalonate, Potassium Sorbate, Sodium Benzoate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Xanthan Gum, Sodium Carbomer, Benzyl Alcohol, Phenoxyethanol

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    PAULAS CHOICE RESIST YOUTH EXTENDING DAILY HYDRATING FLUID SPF 50 
    avonbenzone, octinoxate, octisalate, octocrylene liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76144-781
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE20 mg  in 1 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    VITIS VINIFERA SEED (UNII: C34U15ICXA)  
    CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
    DILL (UNII: Y05PC4JZRH)  
    SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T)  
    OAT BRAN (UNII: KQX236OK4U)  
    PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
    SODIUM CARBONATE (UNII: 45P3261C7T)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CHAMOMILE (UNII: FGL3685T2X)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    LYCIUM BARBARUM FRUIT (UNII: 930626MWDL)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  
    DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76144-781-0160 mL in 1 TUBE; Type 0: Not a Combination Product07/16/2014
    2NDC:76144-781-0215 mL in 1 TUBE; Type 0: Not a Combination Product07/16/2014
    3NDC:76144-781-032 mL in 1 PACKET; Type 0: Not a Combination Product07/16/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35207/16/2014
    Labeler - Paula's Choice, LLC. (029583981)
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