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
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 November 1, 2022
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ACTIVE INGREDIENTS
Homosalate 10%
Zinc Oxide 9.425%
Octisalate 4.50%
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.
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.
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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: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)
