AKWA DAYSTAR SHADE SPF 40- homosalate, zinc oxide, octisalate lotion
Northwest Cosmetic Laboratories, LLC dba Elevation Labs, Idaho

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.

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aKwa Daystar Shade SPF 40 Moisturizing Sunscreen

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AKWA DAYSTAR SHADE SPF 40
homosalate, zinc oxide, octisalate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:62282-410
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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)

Name	Address	ID/FEI	Business Operations
Establishment
Northwest Cosmetic Laboratories, LLC dba Elevation Labs, Idaho		929572014	manufacture(62282-410) , pack(62282-410)

Revised: 6/2022

Document Id: 14fbd002-6392-4408-88bd-ff937a6d14ea

Set id: f2717c35-2c82-4cc0-a53d-d47d3efce11b

Version: 1

Effective Time: 20220606

Northwest Cosmetic Laboratories, LLC dba Elevation Labs, Idaho