Label: AKWA DAYSTAR SHADE SPF 40- homosalate, zinc oxide, octisalate lotion
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- 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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INGREDIENTS AND APPEARANCE
AKWA DAYSTAR SHADE SPF 40
homosalate, zinc oxide, octisalate lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62282-410 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 10 g in 100 mL zinc oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 9.425 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.5 g in 100 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:62282-410-02 1 in 1 CARTON 06/02/2020 1 NDC:62282-410-01 60 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 06/02/2020 Labeler - Northwest Cosmetic Laboratories, LLC dba Elevation Labs, Idaho (929572014) Registrant - Northwest Cosmetic Laboratories, LLC dba Elevation Labs, Idaho (929572014) Establishment Name Address ID/FEI Business Operations Northwest Cosmetic Laboratories, LLC dba Elevation Labs, Idaho 929572014 manufacture(62282-410) , pack(62282-410)
