Label: AKWA DAYSTAR SHADE SPF 40- homosalate, zinc oxide, octisalate lotion

  • NDC Code(s): 54997-410-01, 54997-410-02
  • Packager: 4-Life Reasearch USA, LLC
  • 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 June 3, 2022

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  • ACTIVE INGREDIENTS

    Homosalate 10%

    Zinc Oxide  9.425%

    Octisalate  4.50%

    Purpose

    sunscreen

    Uses

    Helps prevent sunburn

    If used as directed with other sun protection neasures (see ​DIRECTIONS), ​decreases the rist 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 valu 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.

    INACTIVE INGREDIENTS

    Water, butyloctyl salicylate, coco-caprylate/caprate, glycerin, glyceryl stearate, PEG-100 stearate, dimethicone, C14-22 Alkane, Isododecane, Caprylic/Capric triglyceride, acrylates/polytrimethylsiloxymethacrylate copolymer, hydroxyapatite, C12-20 alkyl glucoside, cetearyl glucoside, tocopherol, tocopheryl acetate, tetrahexyldecyl ascorbate, triolein, linoleic acid, oleic acid, palmitic acid, stearic acid, bisabolol, phtosteryl canola glycerides, lecithin, xanthan gum, citric acid, biosaccharide gum-4, phenyl trimethicone, caprylyl glycol, polyglyceryl-3 polyricinoleate, disteardimonium hectorite, isostearic acid, disodium EDTA, 1,2-hexanediol, benzyl alcohol, benzoic acid, vinyl dimethicone/methicone silsesquioxane crosspolymer, ammonium acryloyldimethyltaurate/VP copolymer ,propylene carbonate, fragrance, sodium olivoyl glutamate, glucose, farnesol, cetyl alcohol, stearyl alcohol, ethylhexylglycerin, phenoxyethanol, and propylene glycol.

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    AKWA DAYSTAR SHADE  SPF 40
    homosalate, zinc oxide, octisalate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54997-410
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 mL
    zinc oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION9.425 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    C14-22 ALCOHOLS (UNII: B1K89384RJ)  
    ISODODECANE (UNII: A8289P68Y2)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%) (UNII: 2N8MDB79NA)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)  
    POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)  
    C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    LINOLEIC ACID (UNII: 9KJL21T0QJ)  
    EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CANOLA OIL (UNII: 331KBJ17RK)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    OLEIC ACID (UNII: 2UMI9U37CP)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    GLYCERYL TRIOLEATE (UNII: O05EC62663)  
    BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54997-410-021 in 1 CARTON06/02/2020
    1NDC:54997-410-0160 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35206/02/2020
    Labeler - 4-Life Reasearch USA, LLC (618510226)
    Registrant - Northwest Cosmetic Laboratories, LLC dba Elevation Labs, Idaho (929572014)
    Establishment
    NameAddressID/FEIBusiness Operations
    Northwest Cosmetic Laboratories, LLC dba Elevation Labs, Idaho929572014manufacture(54997-410) , pack(54997-410)