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

aKwa Daystar Shade by

Drug Labeling and Warnings

aKwa Daystar Shade by is a Otc medication manufactured, distributed, or labeled by 4-Life Reasearch USA, LLC, Northwest Cosmetic Laboratories, LLC dba Elevation Labs, Idaho. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54997-410
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: 54997-410-02	1 in 1 CARTON	06/02/2020
1	NDC: 54997-410-01	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	M020	06/02/2020

Labeler - 4-Life Reasearch USA, LLC (618510226)

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(54997-410) , pack(54997-410)