drug facts

drug facts
SPL v6
SPL
SPL Set ID 0710db9f-fe91-4b98-a337-5fde33d98a9d
Route
topical
Published
Effective Date 2021-04-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc cation (20 g)
Inactive Ingredients
glyceryl caprylate laminaria digitata triethoxycaprylylsilane propanediol caprylhydroxamic acid aloe vera leaf water caprylyl caprylate/caprate glycerin coco-caprylate polyglyceryl-2 oleate polyglyceryl-2 stearate polyhydroxystearic acid (2300 mw) magnesium sulfate anhydrous hydrogenated methyl abietate galactoarabinan capryloyl glycerin/sebacic acid copolymer (2000 mpa.s) diheptyl succinate cocos nucifera whole oryza sativa whole rosmarinus officinalis flower helianthus annuus whole tocopherol

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2021-04-05

Purpose

Purpose: Sunscreen

Description

Zinc Oxide 20%


Medication Information

Warnings

For external use only



Do not use on damaged or broken skin.



When using this product keep out of eyes. Rinse with water to remove.



Stop use and ask a docor if rash occurs



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

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

Purpose

Purpose: Sunscreen

Directions

• apply generously 15 minutes before sun exposure

• reapply: •after 40 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

value of 15 or higher and other sun protection measures including:

• limit time in the sun, especially from 10 a.m. - 2 p.m.

• wear long-sleeved shirts, pants, hats, and sunglasses

• children under 6 months of age: Ask a doctor

Other Information

• protect the product in this container from excessive

heat and direct sun

Inactive Ingredients

Water, Capylyl Caprylate/Caprate, Glycerin, Coco-Caprylate, Capric/Caprylic Triglyceride, Polyglycerl-2-Oleate, Polyhydroxystearic Acid, Polyglycerl-2 Stearate, Magnesium Sulfate, Hydrogenated Methyl Abietate, Galactoarabinan, Capryloyl Glycerin/Sebacic Acid Copolymer, Diheptyl Succinate, Cocos Nucifera (Coconut) Oil, Glyceryl Caprylate, Laminaria Digitata Extract, Triethoxycaprylylsilane, Propanediol, Caprylhydroxamic Acid, Aloe Barbadensis Leaf Extract, Oryza Sativa Bran Extract, Rosmarinus Officinalis Extract, Helianthus Annuus Seed Extract, Tocopherol, Natural Fragrance

Description

Zinc Oxide 20%

Principal Display Panel

Active Ingredients

Zinc Oxide 20%

Questions Or Comments?

Conctact us at www.kinfield.com

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.


Structured Label Content

Warnings

For external use only



Do not use on damaged or broken skin.



When using this product keep out of eyes. Rinse with water to remove.



Stop use and ask a docor if rash occurs



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

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

Purpose

Purpose: Sunscreen

Directions

• apply generously 15 minutes before sun exposure

• reapply: •after 40 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

value of 15 or higher and other sun protection measures including:

• limit time in the sun, especially from 10 a.m. - 2 p.m.

• wear long-sleeved shirts, pants, hats, and sunglasses

• children under 6 months of age: Ask a doctor

Other Information

• protect the product in this container from excessive

heat and direct sun

Inactive Ingredients (Inactive ingredients)

Water, Capylyl Caprylate/Caprate, Glycerin, Coco-Caprylate, Capric/Caprylic Triglyceride, Polyglycerl-2-Oleate, Polyhydroxystearic Acid, Polyglycerl-2 Stearate, Magnesium Sulfate, Hydrogenated Methyl Abietate, Galactoarabinan, Capryloyl Glycerin/Sebacic Acid Copolymer, Diheptyl Succinate, Cocos Nucifera (Coconut) Oil, Glyceryl Caprylate, Laminaria Digitata Extract, Triethoxycaprylylsilane, Propanediol, Caprylhydroxamic Acid, Aloe Barbadensis Leaf Extract, Oryza Sativa Bran Extract, Rosmarinus Officinalis Extract, Helianthus Annuus Seed Extract, Tocopherol, Natural Fragrance

Principal Display Panel

Active Ingredients

Zinc Oxide 20%

Questions Or Comments? (Questions or Comments?)

Conctact us at www.kinfield.com

Keep Out of Reach of Children (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.


Advanced Ingredient Data


Raw Label Data

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