Label: DAYDREAM BROAD SPECTRUM SUNSCREEN SPF 40- 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 April 3, 2023

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  • Drug Facts

  • Active ingredient

    Zinc Oxide 17% w/v

  • Purpose

    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.

  • 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 a doctor if • rash occurs

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

  • Directions

    • apply generously to face and neck avoiding eye area 15 minutes before sun exposure.
    • reapply:
      • after 80 minutes of 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 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. - 2 p.m.
      • wear long-sleeved shirts, pants, hats, and sunglasses
    • children under 6 months of age: Ask a doctor

  • Other information

    • protect the product in this container from excessive heat and direct sun

  • Inactive ingredients

    Water, Isododecane, Propanediol, Dimethicone, Caprylic/Capric Triglyceride, Polyglyceryl-6 Polyricinoleate, Polymethylsilsesquioxane/Trimethylsiloxysilicate, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Coco-Caprylate/Caprate, Polyglyceryl-10 Dioleate, Dimethicone/Vinyl Dimethicone Crosspolymer, Polyhydroxystearic Acid, Polyphenylsilsesquioxane, Lecithin, Polysilicone-11, Fructooligosaccharide, Glycoproteins, Bioflavonoids, Cyamopsis Tetragonoloba (Guar) Gum, Glycerin, Butyrospermum Parkii (Shea) Butter, 1,2-Hexanediol, C18-36 Acid Triglyceride, Tribehenin, Disteardimonium Hectorite, Propylene Carbonate, Aminomethyl Propanol, Caprylhydroxamic Acid, Polysorbate 20, Pentylene Glycol, Decyl Glucoside, Xanthan Gum

  • SPL UNCLASSIFIED SECTION

    MEDICAL GRADE SKIN CARE

    UVA/UVB Protection

    100% Mineral Filters

    Water & Sweat Resistant (80 Minutes)

    Oil-Free

    Vegan

    Paraben Free

    Sulfate Free

    Gluten Free

    Fragrance Free

    Never Tested On Animals

    Made in USA with globally sourced components.
    Distributed by: DRMTLGY, LLC
    Canoga Park, CA 91304
    www.DRMTLGY.com

  • Packaging

    DayDreamSunscreen-001

  • INGREDIENTS AND APPEARANCE
    DAYDREAM BROAD SPECTRUM SUNSCREEN SPF 40 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83286-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE17 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISODODECANE (UNII: A8289P68Y2)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR)  
    POLYMETHYLSILSESQUIOXANE/TRIMETHYLSILOXYSILICATE (UNII: X2PZH4Y6HT)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)  
    POLYGLYCERYL-10 DIOLEATE (UNII: 598RES7AXX)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    PHENYLSILANETRIOL (UNII: DNR46JQ8BT)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    SACCHARUM OFFICINARUM STEM FRUCTOOLIGOSACCHARIDES (UNII: 8LLD82AE3S)  
    PLATELET GLYCOPROTEIN VI (UNII: L2RO3AL4JN)  
    CITRUS BIOFLAVONOIDS (UNII: BD70459I50)  
    GUAR GUM (UNII: E89I1637KE)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    C18-36 ACID TRIGLYCERIDE (UNII: ZRA72DR3R7)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83286-001-011 in 1 CARTON02/21/2023
    150 mL in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35202/21/2023
    Labeler - Drmtlgy, LLC (094762235)
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