HAWAIIAN NATURAL ZINC SUNSCREEN SPF 50- zinc oxide lotion 
Kokua Sun Care

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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Hawaiian Natural Zinc Sunscreen SPF 50

Active Ingredient Purpose

Zinc Oxide 25% Sunscreen

Uses

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if rash occurs

Warnings:

Directions

Inactive Ingredients

Water (Aqua), Aloe Barbadensis Leaf Juice, Caprylyl Caprylate/Caprate, Macadamia Ternifolia Seed (Macadamia Nut) Oil, Aleurites Moluccana Seed (Kukui nut) oil, Polyglyceryl-2 Oleate, Polyhydroxystearic Acid, Glycerin, Cocos Nucifera (Coconut) Oil, Cetyl Dimethicone, Magnesium Sulfate, Hydrogenated Methyl Abietate, Galactoarabinan, Propanediol, Polyglyceryl-2 Stearate, KonaRed Hawaiian Coffee Fruit Extract, Morinda Citrifolia Fruit Juice (Noni), Arthrospira Platensis (Hawaiian Spirulina), Oryza Sativa (Rice) Bran Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Helianthus Annuus (Sunflower) Seed Extract, Caprylic/Capric Triglyceride, Prunus Armeniaca (Apricot) Fruit Extract, Musa Sapientum (Banana) Fruit Extract, Santalum Album (Sandalwood) Extract, Butter Extract, Coffea Arabica (Coffee) Leaf/seed Extract, Pyrus Malus (Apple) Fruit Extract, Cocos Nucifera (Coconut) Fruit Extract, Helianthus Annuus (Sunflower) Seed Oil, Tocopherol, Plumeria Alba Flower Extract, Kaolin, Hydrogenated Vegetable Oil, 1,2-Hexanediol, Caprylhydroxamic Acid

Hawaiian Natural Zinc Sunscreen

Broad Spectrum SPF 50

Water Resistant 80 minutes

89 mL / 3 FL OZ

Tube

box

HAWAIIAN NATURAL ZINC SUNSCREEN SPF 50 
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72096-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE25 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
KUKUI NUT OIL (UNII: TP11QR7B8R)  
PLUMERIA ALBA FLOWER (UNII: LGC8P2PC4H)  
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)  
MAGNESIUM SULFATE ANHYDROUS (UNII: ML30MJ2U7I)  
ARABICA COFFEE BEAN (UNII: 3SW678MX72)  
COCONUT (UNII: 3RT3536DHY)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
VANILLA (UNII: Q74T35078H)  
CAPRYLYL CAPRYLATE/CAPRATE (UNII: 22MCG4RSMR)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
APRICOT (UNII: 269CJD5GZ9)  
MUSKMELON (UNII: ZV095H5633)  
KAOLIN (UNII: 24H4NWX5CO)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
GALACTOARABINAN (UNII: SL4SX1O487)  
MACADAMIA OIL (UNII: 515610SU8C)  
COCONUT OIL (UNII: Q9L0O73W7L)  
HYDROGENATED METHYL ABIETATE (UNII: A23O709X8O)  
PROPANEDIOL (UNII: 5965N8W85T)  
POLYGLYCERYL-2 STEARATE (UNII: 253MC0P0YV)  
COFFEA ARABICA FRUIT (UNII: HOX6BEK27Q)  
NONI FRUIT JUICE (UNII: 6ULF85Z07J)  
ARTHROSPIRA PLATENSIS (UNII: 9L3TIH1UUE)  
RICE BRAN (UNII: R60QEP13IC)  
ROSEMARY (UNII: IJ67X351P9)  
CRANBERRY (UNII: 0MVO31Q3QS)  
BANANA (UNII: 4AJZ4765R9)  
APPLE (UNII: B423VGH5S9)  
TOCOPHEROL (UNII: R0ZB2556P8)  
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
SANDALWOOD (UNII: 3641YW25N2)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72096-101-0189 g in 1 BOX; Type 0: Not a Combination Product02/10/2018
2NDC:72096-101-0230 g in 1 BOX; Type 0: Not a Combination Product06/12/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35202/10/2018
Labeler - Kokua Sun Care (081062410)
Establishment
NameAddressID/FEIBusiness Operations
Vege Labs LLC.117878620manufacture(72096-101)

Revised: 6/2023
Document Id: ff24177f-753e-b35d-e053-6394a90ab16f
Set id: 64a5589b-735d-38ba-e053-2a91aa0ad8f4
Version: 4
Effective Time: 20230627
 
Kokua Sun Care