kokua hawaiian natural zinc sunscreen broad spectrum tinted spf 30 (89 ml / 3 fl oz)

kokua hawaiian natural zinc sunscreen broad spectrum tinted spf 30 (89 ml / 3 fl oz)
SPL v2
SPL
SPL Set ID f9a12dac-2fd0-798f-e053-6394a90aa784
Route
topical
Published
Effective Date 2023-04-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (18 g)
Inactive Ingredients
trehalose magnesium sulfate noni fruit arthrospira platensis rosemary capryloyl glycerin/sebacic acid copolymer (2000 mpa.s) ferrosoferric oxide ferric oxide red ferric oxide yellow medium-chain triglycerides plumeria alba flower coco-caprylate/caprate macadamia oil kaolin water polyglyceryl-2 oleate galactoarabinan diheptyl succinate propanediol glycerin aloe vera leaf tetrasodium glutamate diacetate sunflower oil sodium levulinate sodium anisate vanilla bean caprylhydroxamic acid polyglyceryl-2 stearate polyhydroxystearic acid (2300 mw) hydrogenated methyl abietate aleurites moluccanus seed oil cocos nucifera (coconut) fruit

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2023-04-18

Description

Active Ingredients Non Nano Zinc Oxide 18% Purpose Sunscreen


Medication Information

Warnings and Precautions

Warnings

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

Active Ingredients

Non Nano Zinc Oxide 18%

Purpose

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 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
Description

Active Ingredients Non Nano Zinc Oxide 18% Purpose Sunscreen

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 51727-6

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

Section 51945-4

Kokua Sun Care

Tinted SPF 30

Hawaiian Natural Zinc Sunscreen Broad Spectrum SPF 30

80 Minutes

Water Resistant

89 ML/ 3 FL OZ

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

Structured Label Content

Warnings and Precautions (34071-1)

Warnings

  • for external use only
  • Do not use on damaged skin
  • When using this product keep out of eyes. Rinse with water to remove
Active Ingredient (55106-9)

Active Ingredients

Non Nano Zinc Oxide 18%

Purpose

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 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
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 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Kokua Sun Care

Tinted SPF 30

Hawaiian Natural Zinc Sunscreen Broad Spectrum SPF 30

80 Minutes

Water Resistant

89 ML/ 3 FL OZ

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

Advanced Ingredient Data


Raw Label Data

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