HAWAIIAN NATURAL ZINC SUNSCREEN BROAD SPECTRUM TINTED SPF 30- zinc oxide cream

Hawaiian Natural Zinc Sunscreen Broad Spectrum Tinted SPF 30 by

Drug Labeling and Warnings

Hawaiian Natural Zinc Sunscreen Broad Spectrum Tinted SPF 30 by is a Otc medication manufactured, distributed, or labeled by Kokua Sun Care. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Non Nano Zinc Oxide 18%

Purpose

Sunscreen

PURPOSE

Uses

• Helps prevent sunburn
• If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

Stop use and ask a doctor if rash occurs

WARNINGS

Warnings

• for external use only
• Do not use on damaged skin
• When using this product keep out of eyes. Rinse with water to remove

DOSAGE & ADMINISTRATION

Directions

• Apply generously 15 minutes before sun exposure
  • Reapply
    • After 80 minutes of 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 10am - 2pm
    • Wear long-sleeve shirts, pants, hats, and sunglasses
    • Children under 6 months: ask a doctor

INACTIVE INGREDIENT

Water (Aqua), Aloe Barbadensis Leaf Juice, Coco-caprylate/Caprate, Glycerin, Macademia (Ternifolia) Seed Oil, Kukui Seed(Aleurites Moluccana) Oil, Polyglyceryl-2 Oleate, Polyhydroxystearic Acid, Hydrogenated Methyl Abietate, Magnesium Sulfate, Galactoarabinan, Diheptyl Succinate, Capryloyl Glycerin/Sebacic Acid Copolymer, Propanediol, Polyglyceryl-2 Stearate, Caprylic/Capric Triglyceride, Noni (Morinda Citrifola) Fruit Extract, Spirulina (Arthrospira Platensis), Rosmarinus Officinalis (Rosemary) Leaf Extract, Helianthus Annuus (Sunflower) Seed Oil, Coffea Arabica (Coffee) Leaf/Seed Extract, Vanilla planifolia Fruit Extract, Prunus Armeniaca (Apricot) Fruit Extract, Cinnamomium Zeylanicum Bark Extract, Kaolin, Hydrogenated Vegetable Oil, Helianthus Annuus (Sunflower) Seed Oil, Plumeria Alba Flower Extract, Tetrasodium Glutamate Diacetate, Caprylhydroxamic Acid, Sodium Levulinate, Sodium Anisate, Iron oxides

PRINCIPAL DISPLAY PANEL

Kokua Sun Care

Tinted SPF 30

Hawaiian Natural Zinc Sunscreen Broad Spectrum SPF 30

80 Minutes

Water Resistant

89 ML/ 3 FL OZ

INGREDIENTS AND APPEARANCE

HAWAIIAN NATURAL ZINC SUNSCREEN BROAD SPECTRUM TINTED SPF 30 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72096-102
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	18 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PLUMERIA ALBA FLOWER (UNII: LGC8P2PC4H)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
MACADAMIA OIL (UNII: 515610SU8C)
ARABICA COFFEE BEAN (UNII: 3SW678MX72)
KAOLIN (UNII: 24H4NWX5CO)
WATER (UNII: 059QF0KO0R)
POLYGLYCERYL-2 OLEATE (UNII: 5759J47SAM)
GALACTOARABINAN (UNII: SL4SX1O487)
DIHEPTYL SUCCINATE (UNII: 057N7SS26Y)
PROPANEDIOL (UNII: 5965N8W85T)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
SUNFLOWER OIL (UNII: 3W1JG795YI)
SODIUM LEVULINATE (UNII: VK44E1MQU8)
SODIUM ANISATE (UNII: F9WFJ28MV9)
VANILLA BEAN (UNII: Q74T35078H)
APRICOT (UNII: 269CJD5GZ9)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
POLYGLYCERYL-2 STEARATE (UNII: 253MC0P0YV)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
HYDROGENATED METHYL ABIETATE (UNII: A23O709X8O)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
NONI FRUIT (UNII: 7829X3G2X5)
ARTHROSPIRA PLATENSIS (UNII: 9L3TIH1UUE)
ROSEMARY (UNII: IJ67X351P9)
CINNAMON BARK OIL (UNII: XE54U569EC)
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72096-102-01	89 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/18/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M020	04/18/2023

Labeler - Kokua Sun Care (081062410)