drug facts

drug facts
SPL v6
SPL
SPL Set ID 477aa1a2-c893-4750-84da-e5afe7ccd45b
Route
topical
Published
Effective Date 2023-04-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc cation (10.5 g)
Inactive Ingredients
helianthus annuus whole candelilla wax oryza sativa whole cocos nucifera whole raspberry seed oil shea butter polyhydroxystearic acid (2300 mw) theobroma cacao whole calophyllum inophyllum whole simmondsia chinensis seed ammonium glycyrrhizate .beta.-sitosterol squalene hippophae rhamnoides fruit oil mangifera indica seed butter squalane citric acid acetate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2023-04-27

Purpose

Purpose: Sunscreen

Description

Zinc Oxide 10.5%


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: •at least every 2 hours.

• use a water resistant sunscreen if swimming or sweating

• 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

Helianthus Annuus Seed Oil, Caprylic/Capric Triglyceride, Candelilla Cera, Oryza Sativa (Rice) Bran Wax, Cocos Nucifera (Coconut) Oil, Organic Strawberry Flavor, Rubus Idaeus (Raspberry) Seed Oil, Butyrospermum Parkii (Shea) Butter, Polyhydroxystearic Acid, Theobrama Cacao (Cocoa) Seed Butter, Calophyllum Inopyllum (Teamanu) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Ammonium Glycyrrhizate, Beta-Sitosterol, Squalene, Hippophae Rhamnoides (Seabuckthorn) Fruti Oil, Mangifera Indica (Mango) Seed Butter, Squalane, Citric Acid

Description

Zinc Oxide 10.5%

Principal Display Panel

Active Ingredients

Zinc Oxide 10.5%

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: •at least every 2 hours.

• use a water resistant sunscreen if swimming or sweating

• 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)

Helianthus Annuus Seed Oil, Caprylic/Capric Triglyceride, Candelilla Cera, Oryza Sativa (Rice) Bran Wax, Cocos Nucifera (Coconut) Oil, Organic Strawberry Flavor, Rubus Idaeus (Raspberry) Seed Oil, Butyrospermum Parkii (Shea) Butter, Polyhydroxystearic Acid, Theobrama Cacao (Cocoa) Seed Butter, Calophyllum Inopyllum (Teamanu) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Ammonium Glycyrrhizate, Beta-Sitosterol, Squalene, Hippophae Rhamnoides (Seabuckthorn) Fruti Oil, Mangifera Indica (Mango) Seed Butter, Squalane, Citric Acid

Principal Display Panel

Active Ingredients

Zinc Oxide 10.5%

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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