Label: HAWAIIAN NATURAL ZINC SUNSCREEN SPF 50- zinc oxide lotion
- NDC Code(s): 72096-101-01, 72096-101-02
- Packager: Kokua Sun Care
- 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 27, 2023
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- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
-
DOSAGE & ADMINISTRATION
Directions
- Apply generously 15 minutes before sun exposure
- Reapply:
- After 80 minutes if swimming or sweating
- Immediately after towel drying
- At least every 2 hours
- 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 of 15 or higher and other sun protection measures including:
- Limit time in the sun, especially from 10 am-2pm.
- Wear long-sleeve shirts, pants, hats, and sunglasses.
- Children under 6 months: ask a doctor.
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INACTIVE INGREDIENT
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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HAWAIIAN NATURAL ZINC SUNSCREEN SPF 50
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72096-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 25 g in 100 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:72096-101-01 89 g in 1 BOX; Type 0: Not a Combination Product 02/10/2018 2 NDC:72096-101-02 30 g in 1 BOX; Type 0: Not a Combination Product 06/12/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 02/10/2018 Labeler - Kokua Sun Care (081062410) Establishment Name Address ID/FEI Business Operations Vege Labs LLC. 117878620 manufacture(72096-101)