Label: PAULAS CHOICE RESIST YOUTH EXTENDING DAILY HYDRATING FLUID SPF 50- avonbenzone, octinoxate, octisalate, octocrylene liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 76144-781-01, 76144-781-02, 76144-781-03 - Packager: Paula's Choice, LLC.
- 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
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- DO NOT USE
- WHEN USING
- KEEP OUT OF REACH OF CHILDREN
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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
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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 liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76144-781 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 20 mg in 1 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 20 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:76144-781-01 60 mL in 1 TUBE; Type 0: Not a Combination Product 07/16/2014 2 NDC:76144-781-02 15 mL in 1 TUBE; Type 0: Not a Combination Product 07/16/2014 3 NDC:76144-781-03 2 mL in 1 PACKET; Type 0: Not a Combination Product 07/16/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 07/16/2014 Labeler - Paula's Choice, LLC. (029583981)