Label: PLAY EVERYDAY SUNSCREEN SPF 50 WITH SUNFLOWER EXTRACT- avobenzone, homosalate, octisalate, octocrylene cream
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NDC Code(s):
75936-236-01,
75936-236-02,
75936-236-03,
75936-236-04, view more75936-236-05, 75936-236-06
- Packager: Supergoop, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 July 11, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
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DOSAGE & ADMINISTRATION
Directions
- Apply liberally 15 minutes before sun exposure
Reapply:
- after 80 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours
- 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 broad spectrum 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-sleeved shirts, pants, hats, and sunglasses
- Children under 6 months: Ask a doctor
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INACTIVE INGREDIENT
Water, Acrylates Copolymer, Diisopropyl Sebacate, Glycerin, Isodecyl Neopentanoate, Isododecane, Lauryl Lactate, Cetyl Alcohol, Potassium Cetyl Phosphate, Brassica Camprestris/Aleurites Fordi Copolymer, Oryza Sativa (Rice) Bran Extract, Cetearyl Olivate, Ammonium Acryloyldimethyltaurate/VP Copolymer, Hydroxyacetophenone, Sorbitan Olivate, Diethylhexyl Syringylidenemalonate, Aniba Rosaeodora (Rosewood) Wood Oil, Chlorphenesin, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Limon (Lemon) Peel Oil, Ethylhexylglycerin, Eucalyptus Globulus Leaf Oil, Ocimum Bascilicum (Basil) Flower/Leaf Extract, Pelargonium Graveolens Flower Oil, Pogostemon Cablin Oil, Pentylene Glycol, 1,2-hexanediol, Caprylyl Glycol, Xanthan Gum, Helianthus Annuus (Sunflower) Extract, Behenic Acid, Cetyl Behenate, Isostearyl Isostearate, Trisodium Ethylenediamene Disuccinate, Tocopherol, Allantoin, Rosmarinus Officinalis (Rosemary) Leaf Extract, Caprylic/Capric Triglyceride,Panthenol, Pentasodium Triphosphate, Citric Acid
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PLAY EVERYDAY SUNSCREEN SPF 50 WITH SUNFLOWER EXTRACT
avobenzone, homosalate, octisalate, octocrylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75936-236 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 10 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 7.5 g in 100 mL Inactive Ingredients Ingredient Name Strength MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) WATER (UNII: 059QF0KO0R) DIISOPROPYL SEBACATE (UNII: J8T3X564IH) GLYCERIN (UNII: PDC6A3C0OX) ISODECYL NEOPENTANOATE (UNII: W60VYE24XC) ISODODECANE (UNII: A8289P68Y2) LAURYL LACTATE (UNII: G5SU0BFK7O) CETYL ALCOHOL (UNII: 936JST6JCN) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) RICE BRAN (UNII: R60QEP13IC) CETEARYL OLIVATE (UNII: 58B69Q84JO) AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) SORBITAN OLIVATE (UNII: MDL271E3GR) DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248) ROSEWOOD OIL (UNII: F2522O5L7B) CHLORPHENESIN (UNII: I670DAL4SZ) ORANGE OIL (UNII: AKN3KSD11B) LEMON OIL (UNII: I9GRO824LL) EUCALYPTUS OIL (UNII: 2R04ONI662) OCIMUM BASILICUM FLOWERING TOP (UNII: 7SAB275FP2) PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC) POGOSTEMON CABLIN LEAF OIL (UNII: F3IN55X5PO) PENTYLENE GLYCOL (UNII: 50C1307PZG) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) CAPRYLYL GLYCOL (UNII: 00YIU5438U) XANTHAN GUM (UNII: TTV12P4NEE) HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP) BEHENIC ACID (UNII: H390488X0A) CETYL BEHENATE (UNII: WFM51TRO3E) ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y) TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q) TOCOPHEROL (UNII: R0ZB2556P8) ALLANTOIN (UNII: 344S277G0Z) ROSEMARY (UNII: IJ67X351P9) PANTHENOL (UNII: WV9CM0O67Z) SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75936-236-01 3 mL in 1 TUBE; Type 0: Not a Combination Product 01/01/2020 2 NDC:75936-236-02 10 mL in 1 TUBE; Type 0: Not a Combination Product 01/01/2020 3 NDC:75936-236-03 30 mL in 1 TUBE; Type 0: Not a Combination Product 01/01/2020 4 NDC:75936-236-04 71 mL in 1 TUBE; Type 0: Not a Combination Product 01/01/2020 5 NDC:75936-236-05 162 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2020 6 NDC:75936-236-06 532 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 01/01/2020 Labeler - Supergoop, LLC (117061743)