Label: RADIANCE SILKY MINERAL PRIMER SUNSCREEN SPF-42 HONEY- titanium dioxide, zinc oxide solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 6, 2023

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active ingredients

    Titanium Dioxide 6% Zinc Oxide 8%

    Purpose

    Sunscreen

  • Uses:

    • Helps prevent sunburn.
    • Higher SPF gives more sunburn protection.
    • Retains SPF after 80 minutes of swimming or sweating.
    • If used as as directed with other sun protection measures (see directions), decreases the risk of 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 doctor if

    • Rash occurs.

    Keep out of reach of children.

    If swallowed, get medical help, or contact a Poison Control Center right away.

    If pregnant or breastfeeding,

    Ask a health professional before use.

  • Directions:

    • Apply liberally 15 minutes before sun exposure and as needed.
    • Reapply:
    • After 80 minutes of swimming or sweating
    • Immediately after towel drying
    • At least every 2 hours
    • Children under 6 months of age: ask a doctor.
    • Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use sunscreen with a Broad  Spectrum SPF value of 15 or higher and other sun protection measures including: Sun Protection Measures.
    • Limit time in the sun, especially from 10 a.m. - 2 p.m.
    • Wear long-sleeved shirts, pants, hats, and sunglasses.
  • Other information.

    • Protect the product in this container from excessive heat and direct sun.
  • Inactive Ingredients:

    Bis-Vinyl Dimethicone/ Dimethicone Copolymer, Camellia Sinensis (Green Tea) Extract, Caprylic/ Capric Triglyceride, Cetyl PEG/PPG-10/1 Dimethicone, Cocos Nucifera (Coconut) Oil, Cyclopentasiloxane, Cyclotetrasiloxane, Dimethicone, Dimethiconol, Helianthus Annus (Sunflower) Oil, Iron Oxides (Black, Red, White, Yellow), Rubus Idaeus (Raspberry) Extract, Silica, Tetrahexyldecyl Ascorbate (Vitamin C), Tocopheryl Acetate (Vitamin E), Tridecyl Salicylate Triethoxycaprylylsilane

  • Questions?

    (855) REMEDIO

  • Package Labeling:

    Label0

  • INGREDIENTS AND APPEARANCE
    RADIANCE SILKY MINERAL PRIMER SUNSCREEN SPF-42 HONEY 
    titanium dioxide, zinc oxide solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81352-521
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE60 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION80 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    CYCLOMETHICONE 4 (UNII: CZ227117JE)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    RASPBERRY (UNII: 4N14V5R27W)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81352-521-001 in 1 BOX03/06/2023
    150 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02003/06/2023
    Labeler - SANTO REMEDIO LLC (117456185)