Label: COOLA MINERAL SUN SILK CREME SUNSCREEN SPF 30- zinc oxide lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 17, 2019

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  • DRUG FACTS

    Active ingredients

    Zinc Oxide 15%

  • PURPOSE

    Purpose

    Sunscreen

  • INDICATIONS & USAGE

    Uses

    * helps prevent sunburn

    * if used as directed with other sun protection measures (see Directions), decreases the rise of skin cancer and early skin aging caused by the sun

  • WARNINGS AND PRECAUTIONS

    Warnings

    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.

    Stop use and ask doctor if skin rash occurs

    Keep out of reach of children. If prodcut is swallowed, get medical help or contact Poison Control Center right away.

    Do not use on damaged or broken skin

    When using this product keep out of eyes. Rinse with water to remove

    Stop use and ask doctor if skin rash occurs

    Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

  • 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

    Inactive ingredients

    Aloe Barbadensis Leaf Juice (ORGANIC), Butylene Glycol, Caprylyl Glycol, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Didecyldimonium Chloride, Dimethicone, Glyceryl Caprylate, Glyceryl Stearate Citrate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Jasminum Sambac Leaf Cell Extract, Methylpropanediol, Niacinamide, PEG-7 Trimethylolpropane Coconut Ether, Polyhydroxystearic Acid, Polyisobutene, Polyquaternium-80, Propanediol, Schinus Molle Extract, Theobroma Cacao (Cocoa) Seed Extract.

  • OTHER SAFETY INFORMATION

    Other information


    * protect this product from excessive heat and direct sun

  • QUESTIONS

    Questions or comments? Call 760-940-2125

  • INSTRUCTIONS FOR USE

    How to use:

    Apply daily to cleansed skin,

    15 minutes before sun exposure.

    Dispense into palm of hand and

    apply evenly across face and

    neck using upward strokes,

  • PRINCIPAL DISPLAY PANEL

    Mineral Silk Sunscreen 44 mL Tube

    Mineral Silk Sunscreen 44 mL Carton

  • INGREDIENTS AND APPEARANCE
    COOLA MINERAL SUN SILK CREME SUNSCREEN  SPF 30
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21839-550
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE150 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    COCOA (UNII: D9108TZ9KG)  
    SCHINUS MOLLE FRUITING TOP (UNII: T8L6O1KSB4)  
    POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
    JASMINUM SAMBAC FLOWER (UNII: 2S686I937F)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21839-550-011 in 1 BOX12/11/2018
    1NDC:21839-550-0244 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35212/11/2018
    Labeler - GORDON LABORATORIES,INC (008328619)
    Registrant - GORDON LABORATORIES,INC (008328619)
    Establishment
    NameAddressID/FEIBusiness Operations
    GORDON LABORATORIES,INC008328619manufacture(21839-550)
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