Label: DAYSTAR SHADE SPF MOISTURIZING SUNSCREEN- homosalate, zinc oxide, octisalate lotion

  • NDC Code(s): 54997-056-00
  • Packager: 4Life Research USA, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 7, 2024

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  • Drug Facts

  • Active ingredients

    Homosalate 10.0%

    Zinc Oxide 9.4%

    Octisalate 4.5%

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

  • DIRECTIONS:

    • Apply generously and evenly 15 minutes before sun exposure.
    • Reapply at least every 2 hours during sun exposure.
    • Use a water-resistant sunscreen if swimming or sweating.
    • 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 10:00 am-2:00 pm.

      • Wear long-sleeved shirts, pants, hats, and sunglasses.

    • Children under 6 months of age: Ask a doctor.
  • Other Information

    • Protect this product from excessive heat and direct sun.
    • Product may stain some fabrics.
  • INACTIVE INGREDIENTS:

    Water, Butyloctyl Salicylate, Coco-Caprylate/Caprate, Glyceryl Stearate, Glycerin, Acrylates/Polytrimethylsiloxymethacrylate Copolymer, Isododecane, PEG-100 Stearate, Caprylic/Capric Triglyceride, Dimethicone, C12-20 Alkyl Glucoside, C14-22 Alcohol, Phenyl Trimethicone, Cetearyl Glucoside, Hydroxyapatite, Isostearic Acid, Polyglyceryl-3 Polyricinoleate, Benzyl Alcohol, Biosaccharide Gum-4, Caprylyl Glycol, Fragrance, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Ammonium Acryloyldimonium Hectorite, Cetearyl Alcohol, Xanthan Gum, Benzoic Acid, Lecithin, Linoleic Acid, Propylene Carbonate, Disodium EDTA, Tocopheryl Acetate, Oleic Acid, Tetrahexyldecyl Ascorbate, Palmitic Acid, Phytosteryl Canola Glycerides, Citric Acid, Stearic Acid, Stearic Acid, Tocopherol, Trolein, Bisabolol, Benzyl Salicylate, Citronellol and Hexyl Cinnamal.

  • Questions or comments?

    Call toll free 888-454-3374

  • Package Labeling:

    Outer LabelInner Label

  • INGREDIENTS AND APPEARANCE
    DAYSTAR SHADE SPF MOISTURIZING SUNSCREEN 
    homosalate, zinc oxide, octisalate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54997-056
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION94 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE45 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISODODECANE (UNII: A8289P68Y2)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    LINOLEIC ACID (UNII: 9KJL21T0QJ)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    OLEIC ACID (UNII: 2UMI9U37CP)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54997-056-001 in 1 CARTON06/07/2024
    160 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02006/07/2024
    Labeler - 4Life Research USA, LLC (618510226)
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