Label: PLAY ANTIOXIDANT BODY MIST SPF 50 WITH VITAMIN C- avobenzone, homosalate, octisalate, octocrylene spray
- NDC Code(s): 75936-154-01, 75936-154-02
- 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 October 27, 2022
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
-
DOSAGE & ADMINISTRATION
Directions
Apply generously 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 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-sleeve shirts, pants, hats, and sunglassesChildren under 6 months: Ask a doctor
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INACTIVE INGREDIENT
Alcohol Denat., Butyloctyl Salicylate, Camellia Sinensis Leaf Extract, Cananga Odorata Flower Oil, Caprylic/Capric Triglyceride, Citrus Grandis (Grapfruit) Peel Oil, Citrus medica Limonium (Lemon) Oil, Citrus Nobilis (Mandarin Orange) Peel Oil, Citrus reticulata (Tangerine) Leaf Oil, Citrus Sinensis peel Oil, Dicaprylyl Carbonate, Diisopropyl adiipate, Ethyl Ferulate, Euterpe Oleracea Fruit Extract, Helianthuus Annuus (Sunflower) Seed Oil, Isodecyl Neopentanoate, Lavandula Angustifolia (Lavender) Oil, Mentha Piperita (Peppermint) Oil, Mentha Viridis(Spearmint) Tetrahexyldecyl Ascorbate, Tridecyl Neopentanoate, VA/Butyl Maleate/ Isobornyl Acrylate Copolymer, Vitis Vinifera (Grape) Seed Oil
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
PLAY ANTIOXIDANT BODY MIST SPF 50 WITH VITAMIN C
avobenzone, homosalate, octisalate, octocrylene sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75936-154 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 9.8 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.9 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 9.5 g in 100 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2.8 g in 100 mL Inactive Ingredients Ingredient Name Strength MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) ORANGE OIL (UNII: AKN3KSD11B) ETHYL FERULATE (UNII: 5B8915UELW) ACAI (UNII: 46AM2VJ0AW) ALCOHOL (UNII: 3K9958V90M) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) GREEN TEA LEAF (UNII: W2ZU1RY8B0) CITRUS RETICULATA LEAF OIL (UNII: 1515UE78IH) LAVENDER OIL (UNII: ZBP1YXW0H8) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) DIISOPROPYL ADIPATE (UNII: P7E6YFV72X) PEPPERMINT OIL (UNII: AV092KU4JH) MENTHA SPICATA OIL (UNII: C3M81465G5) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) GRAPE SEED OIL (UNII: 930MLC8XGG) LEMON OIL (UNII: I9GRO824LL) MANDARIN OIL (UNII: NJO720F72R) CANANGA OIL (UNII: 8YOY78GNNX) LIME OIL (UNII: UZH29XGA8G) SUNFLOWER OIL (UNII: 3W1JG795YI) ISODECYL NEOPENTANOATE (UNII: W60VYE24XC) CITRUS MAXIMA FRUIT RIND OIL (UNII: 8U3877WD44) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75936-154-01 89 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 01/17/2020 2 NDC:75936-154-02 177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 01/17/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 01/17/2020 Labeler - Supergoop, LLC (117061743) Establishment Name Address ID/FEI Business Operations Bell International Laboratories 967781555 manufacture(75936-154)