Label: SILK SPF FACIAL SUNSCREEN FLUID HYBRID BROAD SPECTRUM SPF 30 UVA/UVB- zinc oxide and homosalate cream

  • NDC Code(s): 79356-202-01, 79356-202-02
  • Packager: OneKind.25
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 28, 2023

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  • ACTIVE INGREDIENT

    Active Ingredients

    Zinc Oxide 10.5%

    Homosalate 10%

  • PURPOSE

    Purpose

    Sunscreen

  • INDICATIONS & USAGE


    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


    Warnings
    For external use only.

  • DO NOT USE

    Do not use on damaged or broken skin.

  • WHEN USING


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

  • STOP USE

    Stop use and ask a doctor if rash occurs.

  • KEEP OUT OF REACH OF CHILDREN


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

  • DOSAGE & ADMINISTRATION


    Directions
    Apply generously 15 minutes before sun
    exposure. Reapply at least every 2 hours.
    Use a water-resistant sunscreen if
    swimming or sweating.

  • 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 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.

  • INACTIVE INGREDIENT


    Inactive Ingredients
    water/aqua/eau, caprylic/capric
    triglyceride, glyceryl stearate se, coconut
    alkanes, glycerin, coco-caprylate/caprate,
    decyl glucoside, oryza sativa (rice) starch,
    musa sapientum (banana) flower extract,
    polyhydroxystearic acid, polyglyceryl-3
    polyricinoleate, isostearic acid, lecithin,
    xanthan gum, hydroxyethylcellulose,
    caprylyl glycol, caprylhydroxamic acid,
    sodium benzoate, citric acid, disodium
    phosphate, sodium phosphate.

  • PRINCIPAL DISPLAY PANEL

    CODSilkSPF30

  • INGREDIENTS AND APPEARANCE
    SILK SPF FACIAL SUNSCREEN FLUID HYBRID BROAD SPECTRUM SPF 30 UVA/UVB 
    zinc oxide and homosalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79356-202
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE10.5 g  in 100 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
    MUSA X PARADISIACA FLOWER (UNII: DG5B0M0NGY)  
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    SODIUM PHOSPHATE (UNII: SE337SVY37)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    COCONUT ALKANES (UNII: 1E5KJY107T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    STARCH, RICE (UNII: 4DGK8B7I3S)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79356-202-021 in 1 CARTON02/01/2022
    1NDC:79356-202-0148 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02002/01/2022
    Labeler - OneKind.25 (080286020)
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