Label: SUNSCREEN MIST BROAD SPECTRUM SPF 50 SUPERGOOP- avobenzone, homosalate, octinoxate, octisalate, octocrylene spray
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Contains inactivated NDC Code(s)
NDC Code(s): 75936-124-01, 75936-124-02, 75936-124-03 - Packager: TAYLOR JAMES, LTD.
- 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 January 5, 2017
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
Active Ingredients Purpose
Avobenzone 3% SunscreenHomosalate 10% Sunscreen
Octinoxate 7.5% Sunscreen
Octisalate 5% Sunscreen
Octocrylene 10% 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
Keep out of reach of children
Stop use and ask a doctor if rash occurs
Warnings Flammable. Keep away from flames and sparks
For external use only.
Do not use on damaged or broken skin.
When using this product, keep out of eyes. Rinse with water to remove.
If swallowed, get medical help or contact a Poison Control Center right away.
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 when exposed to sunlight
Children under 6 months: Ask a doctor
Inactive Ingredients Alcohol Denat , Camellia Sinensis Leaf Extract, Cananga Odorata Flower Oil, Caprylic/Capric triglyceride, Citrus Aurantifolia (Lime) Oil, Citrus Grandis (Grapefruit) Peel Oil, Citrus Limon Fruit Oil, Citrus Nobilis (Mandarin Orange) Peel Oil, Citrus Reticulata (Tangerine) Peel Oil, Citrus Sinensis Peel Oil, Dicaprylyl Carbonate, Diisopropyl Adipate, Euterpe Oleracea Fruit Extract, Helianthuus Annuus (Sunflower) Seed Oil, Isodecyl Neopentanoate, Lavandula Angustifolia Mentha Piperita (Peppermint) Oil, Mentha Viridis (Spearmint) Leaf Oil, Tetrahexyldecyl Ascorbate (vitamin C), Tridecyl Neopentanoate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Vitis Vinifera (Grape) Seed Oil.
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INGREDIENTS AND APPEARANCE
SUNSCREEN MIST BROAD SPECTRUM SPF 50 SUPERGOOP
avobenzone, homosalate, octinoxate, octisalate, octocrylene sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75936-124 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 OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 10 g in 100 mL Inactive Ingredients Ingredient Name Strength GREEN TEA LEAF (UNII: W2ZU1RY8B0) CANANGA OIL (UNII: 8YOY78GNNX) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) LIME OIL (UNII: UZH29XGA8G) CITRUS MAXIMA FRUIT RIND OIL (UNII: 8U3877WD44) CITRUS LIMON FRUIT OIL (UNII: 0HNC1J1YED) MANDARIN OIL (UNII: NJO720F72R) ORANGE OIL TERPENELESS (UNII: L8B7EWV9I7) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) DIISOPROPYL ADIPATE (UNII: P7E6YFV72X) ACAI (UNII: 46AM2VJ0AW) SUNFLOWER OIL (UNII: 3W1JG795YI) ISODECYL NEOPENTANOATE (UNII: W60VYE24XC) LAVENDER OIL (UNII: ZBP1YXW0H8) PEPPERMINT OIL (UNII: AV092KU4JH) SPEARMINT OIL (UNII: C3M81465G5) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) TRIDECYL NEOPENTANOATE (UNII: 3Z8H1DA7J5) GRAPE SEED OIL (UNII: 930MLC8XGG) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75936-124-02 1 in 1 PACKAGE 01/29/2013 1 NDC:75936-124-01 177 mL in 1 CAN; Type 0: Not a Combination Product 2 NDC:75936-124-03 89 mL in 1 CAN; Type 0: Not a Combination Product 01/29/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 01/29/2013 Labeler - TAYLOR JAMES, LTD. (033381850) Registrant - TAYLOR JAMES, LTD. (033381850) Establishment Name Address ID/FEI Business Operations Bell International Laboratories 967781555 manufacture(75936-124)
