Label: COOLA FULL SPECTRUM 360 SUN SILK DROPS SPF 30- avobenzone,homosalate, octisalate,octocrylene liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 21839-620-01, 21839-620-02, 21839-620-03, 21839-620-04 - Packager: Gordon Laboratories, Inc.
- 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 December 18, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- DRUG FACTS
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS AND PRECAUTIONS
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DOSAGE & ADMINISTRATION
Directions
* shake well * apply liberally 15 minutes before sun exposure
* reapply: * after 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 aging. To decrease this risk, regularly use a sunscreen with a 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 sunglasses
* children under 6 months: Ask a doctor -
INACTIVE INGREDIENT
Aloe Barbadensis Leaf Extract (Organic), Anthemis Nobilis (Chamomile) Flower Oil, Butylene Glycol, Butyloctyl Salicylate, Calcium Gluconate, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Organic Safflower) Seed Oil, Citrus Aurantium Amara (Bitter Orange) Flower Extract, Citrus Aurantium Amara (Bitter Orange) Leaf/Twig Extract, Dicaprylyl Carbonate, Glycerin (Organic), Glyceryl Stearate Se, Jasminum Sambac (Jasmine) Leaf Cell Extract, Nylon-12, Olea Europaea (Organic Olive) Fruit Oil, Plankton Leaf Extract, Propanediol, Schinus Molle Extract, Simmondsia Chinensis (Organic Jojoba) Seed Oil, Sodium Benzoate, Sodium Hyaluronate, Sodium Stearoyl Glutamate, Theobroma Cacao (Cocoa) Seed Extract, Tocopheryl Acetate, Water (Aqua), Xanthan Gum
- OTHER SAFETY INFORMATION
- QUESTIONS
- INSTRUCTIONS FOR USE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
COOLA FULL SPECTRUM 360 SUN SILK DROPS SPF 30
avobenzone,homosalate, octisalate,octocrylene liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21839-620 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 HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 100 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 60 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) HYALURONATE SODIUM (UNII: YSE9PPT4TH) SODIUM BENZOATE (UNII: OJ245FE5EU) PROPANEDIOL (UNII: 5965N8W85T) OLIVE OIL (UNII: 6UYK2W1W1E) GLUCONOLACTONE (UNII: WQ29KQ9POT) ALOE VERA LEAF (UNII: ZY81Z83H0X) COCOA (UNII: D9108TZ9KG) SCHINUS MOLLE FRUITING TOP (UNII: T8L6O1KSB4) JASMINUM SAMBAC FLOWER (UNII: 2S686I937F) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) CITRUS AURANTIUM FLOWER OIL (UNII: D4BGE91OXH) SAFFLOWER OIL (UNII: 65UEH262IS) NYLON-12 (UNII: 446U8J075B) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839) XANTHAN GUM (UNII: TTV12P4NEE) JOJOBA OIL (UNII: 724GKU717M) GLYCERIN (UNII: PDC6A3C0OX) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:21839-620-02 1 in 1 NOT APPLICABLE 12/20/2018 1 NDC:21839-620-01 5 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:21839-620-04 1 in 1 CARTON 12/20/2018 2 NDC:21839-620-03 30 mL in 1 BOTTLE; 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 12/20/2018 Labeler - Gordon Laboratories, Inc. (008328619) Registrant - Gordon Laboratories, Inc. (008328619) Establishment Name Address ID/FEI Business Operations GORDON LABORATORIES,INC 008328619 manufacture(21839-620)