Label: SUNSCREEN MIST BROAD SPECTRUM SPF 30 SUPERGOOP- avobenzone, homosalate, octinoxate, octisalate, octocrylene spray
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Contains inactivated NDC Code(s)
NDC Code(s): 75936-123-01, 75936-123-02, 75936-123-03 - 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 20, 2017
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ACTIVE INGREDIENT
Active Ingredients Purpose
Avobenzone 3% Sunscreen
Homosalate 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 Flamamble. 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
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 a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
limit time in the sun, especially from 10 a.m.-2p.m.
wear long-sleved shirts, pants, hats, and sunglasses
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, Helianthus Annuus (Sunflower) Seed Oil, Isodecyl Neoppentanoate, Lavandula Angustifolia (lavender) Oil, Mentha Piperita (Peppermint Oil) Mentha Viridis (Spearmint) Leaf Oil, Tetrahexyldecyl Ascorbate (Vitamin C), Tridecyl Neopentanoate, VA/Butyl Maleate/Isobornyl Acrylate Coploymer, Vitis Vinifera (Grape) Seed Oil.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SUNSCREEN MIST BROAD SPECTRUM SPF 30 SUPERGOOP
avobenzone, homosalate, octinoxate, octisalate, octocrylene sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75936-123 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:75936-123-01 177 mL in 1 CAN; Type 0: Not a Combination Product 01/07/2013 2 NDC:75936-123-03 1 in 1 PACKAGE 01/07/2013 2 NDC:75936-123-02 89 mL in 1 CAN; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 01/07/2013 Labeler - TAYLOR JAMES, LTD. (033381850) Registrant - TAYLOR JAMES, LTD. (033381850) Establishment Name Address ID/FEI Business Operations Bell International Laboratories 967781555 manufacture(75936-123)
