Label: CBD BLUE LIGHT DEFENSE SPF 30- zinc oxide cream

  • 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 11, 2020

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  • ACTIVE INGREDIENT

    Active Ingredient

    Zinc Oxide 18.90%

  • PURPOSE

    Purpose: Sunscreen

  • INDICATIONS & USAGE

    Uses:

    • Helps prevent sunburn.
    • If used as directed with other sun protection measure, this product decreases the risk of skin cancer and early skin aging caused by the sun.
  • WARNINGS

    Warnings:

    • For External Use Only
  • DO NOT USE

    Do not use on damaged or broken skin.

  • STOP USE

    Stop use and ask a doctor if rash occurs.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach odf childern. If product is swallowed, get medical help or contact a posion control center right away.

  • DOSAGE & ADMINISTRATION

    Directions:

    • Apply liberally 15 minutes before sun exposure.
    • Children under 6 months of age: Ask a doctor
    • Reapply at least every 2 hours.

  • OTHER SAFETY INFORMATION

    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 Specturm SPF value of 15 or higher and other sun protection measures including:

    • Limit time in the sun, especially form 10 a.m. - 2:0 pm
    • Wear long sleeved shirts, pants, hats and sunglasses.
    • Protect the product in this container form excessive heat and direct sun.
  • INACTIVE INGREDIENT

    Other Ingredients: Water (Aqua), Caprylic/Capric Triglyceride , Coco-Caprylate/Caprate , Cetearyl Alcohol, Glycerin , Aloe Barbadensis Leaf Juice , Coco-Glucoside, Jojoba Esters , Dipotassium Glycyrrhizate , Sodium Phytate, Alcohol, Caprylyl/Capryl Glucoside, Xanthan Gum , Sclerotium Gum, Polyhydroxystearic acid, Polyglyceryl-3 Polyricinoleate, Isostearic Acid, Lecithin, Cetearyl Glucoside, Butyrospermum Parkii Nut Extract , Coconut Alkanes , Tocopherol , Tetrahexyldecyl Ascorbate, Cellulose (Microsponge/Delivery System), Hydroxyapatite, Cannabidiol (From Hemp Extract) , Caesalpinia Spinosa Fruit Extract, Helianthus Annuus (Sunflower) Sprout Extract, Pyrus Malus (Apple) Fruit Extract , Sodium Benzoate, Phenoxyethanol , Ethylhexylglycerin, Propylene Glycol

  • PRINCIPAL DISPLAY PANEL

    Msanufacture for

    Dermaquest®, Inc.

    Hayward, CA-94544

    Made in USA

    dermaquestinc.com

    IMGCBDBLDSPF30

  • INGREDIENTS AND APPEARANCE
    CBD BLUE LIGHT DEFENSE SPF 30 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4196
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE189 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
    CANNABIDIOL (UNII: 19GBJ60SN5)  
    CAESALPINIA SPINOSA FRUIT POD (UNII: EXY4496LWD)  
    APPLE (UNII: B423VGH5S9)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    SHEANUT (UNII: 84H6HBP32L)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    HELIANTHUS ANNUUS SPROUT (UNII: 4P26HG1S5W)  
    BETASIZOFIRAN (UNII: 2X51AD1X3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    COCONUT ALKANES (UNII: 1E5KJY107T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
    PHYTATE SODIUM (UNII: 88496G1ERL)  
    ALCOHOL (UNII: 3K9958V90M)  
    CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62742-4196-157 g in 1 TUBE; Type 0: Not a Combination Product12/11/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35212/11/2020
    Labeler - Allure Labs (926831603)
    Registrant - Allure Labs (926831603)
    Establishment
    NameAddressID/FEIBusiness Operations
    Allure Labs926831603manufacture(62742-4196)
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