kokua hawaiian natural zinc sunscreen spf 50 (89 ml / 3 fl oz) (30 ml / 1 fl oz)

kokua hawaiian natural zinc sunscreen spf 50 (89 ml / 3 fl oz) (30 ml / 1 fl oz)
SPL v5
SPL
SPL Set ID 64a5589b-735d-38ba-e053-2a91aa0ad8f4
Route
topical
Published
Effective Date 2025-12-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (25 g)
Inactive Ingredients
polyglyceryl-2 oleate glyceryl stearate polyglyceryl-2 stearate noni fruit juice arthrospira platensis rice bran rosemary alpha-tocopherol acetate caprylhydroxamic acid medium-chain triglycerides kaolin 1,2-hexanediol galactoarabinan macadamia oil coconut oil glycerin water aloe vera leaf juice kukui nut oil plumeria alba flower cetyl dimethicone 25 magnesium sulfate coconut sunflower oil vanilla planifolia fruit caprylyl caprylate/caprate polyhydroxystearic acid (2300 mw) hydrogenated methyl abietate propanediol

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2018-02-10

Description

Active Ingredient Purpose Zinc Oxide 25% Sunscreen


Medication Information

Warnings and Precautions

Warnings:

  • For external use only
  • Do not use or broken skin
  • When using this product keep out of eyes
Active Ingredient

Active Ingredient Purpose

Zinc Oxide 25% Sunscreen

Indications and Usage

Stop use and ask a doctor if rash occurs

Dosage and 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.
Inactive Ingredients

Inactive Ingredients

Water (Aqua), Aloe Barbadensis Leaf Juice, Caprylyl Caprylate/Caprate, Polyglyceryl-2 Oleate, Macadamia Ternifolia Seed (Macadamia) Oil, Aleurites Moluccana Seed (Kukui) Oil, Polyhydroxystearic Acid, Cocos Nucifera (Coconut) Oil, Cetyl Dimethicone, Glyceryl Stearate, Glycerin, Hydrogenated Methyl Abietate, Magnesium Sulfate, Galactoarabinan, Propanediol, Polyglyceryl-2 Stearate, Morinda Citrifolia (Noni) Fruit Juice, Arthrospira Platensis (Hawaiian Spirulina), Oryza Sativa (Rice) Bran Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Helianthus Annuus (Sunflower) Seed Extract, Caprylic/Capric Triglyceride, Vanilla Planifolia Fruit Extract, Cocos Nucifera (Coconut) Fruit Extract, Tocopheryl Acetate, Plumeria Alba Flower Extract, Kaolin, Hydrogenated Vegetable Oil, 1,2-Hexanediol, Caprylhydroxamic Acid.

Description

Active Ingredient Purpose Zinc Oxide 25% Sunscreen

Principal Display Panel

Hawaiian Natural Zinc Sunscreen

Broad Spectrum SPF 50

Water Resistant 80 minutes

89 mL / 3 FL OZ

Section 50565-1

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

Section 55105-1

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 caused by the sun.

Structured Label Content

Warnings and Precautions (34071-1)

Warnings:

  • For external use only
  • Do not use or broken skin
  • When using this product keep out of eyes
Active Ingredient (55106-9)

Active Ingredient Purpose

Zinc Oxide 25% Sunscreen

Indications and Usage (34067-9)

Stop use and ask a doctor if rash occurs

Dosage and Administration (34068-7)

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.
Inactive Ingredients

Inactive Ingredients

Water (Aqua), Aloe Barbadensis Leaf Juice, Caprylyl Caprylate/Caprate, Polyglyceryl-2 Oleate, Macadamia Ternifolia Seed (Macadamia) Oil, Aleurites Moluccana Seed (Kukui) Oil, Polyhydroxystearic Acid, Cocos Nucifera (Coconut) Oil, Cetyl Dimethicone, Glyceryl Stearate, Glycerin, Hydrogenated Methyl Abietate, Magnesium Sulfate, Galactoarabinan, Propanediol, Polyglyceryl-2 Stearate, Morinda Citrifolia (Noni) Fruit Juice, Arthrospira Platensis (Hawaiian Spirulina), Oryza Sativa (Rice) Bran Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Helianthus Annuus (Sunflower) Seed Extract, Caprylic/Capric Triglyceride, Vanilla Planifolia Fruit Extract, Cocos Nucifera (Coconut) Fruit Extract, Tocopheryl Acetate, Plumeria Alba Flower Extract, Kaolin, Hydrogenated Vegetable Oil, 1,2-Hexanediol, Caprylhydroxamic Acid.

Principal Display Panel

Hawaiian Natural Zinc Sunscreen

Broad Spectrum SPF 50

Water Resistant 80 minutes

89 mL / 3 FL OZ

Section 50565-1 (50565-1)

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

Section 55105-1 (55105-1)

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 caused by the sun.

Advanced Ingredient Data


Raw Label Data

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