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

  • NDC Code(s): 62282-410-01, 62282-410-02
  • Packager: Northwest Cosmetic Laboratories, LLC dba Elevation Labs, Idaho
  • 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 6, 2022

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  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    AKWA DAYSTAR SHADE  SPF 40
    homosalate, zinc oxide, octisalate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62282-410
    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:62282-410-021 in 1 CARTON06/02/2020
    1NDC:62282-410-0160 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 - Northwest Cosmetic Laboratories, LLC dba Elevation Labs, Idaho (929572014)
    Registrant - Northwest Cosmetic Laboratories, LLC dba Elevation Labs, Idaho (929572014)
    Establishment
    NameAddressID/FEIBusiness Operations
    Northwest Cosmetic Laboratories, LLC dba Elevation Labs, Idaho929572014manufacture(62282-410) , pack(62282-410)