Sport Broad Spectrum Spf50+ Water Resistant (80 Minutes) Mineral Sunscreen Uva/uvb Protection Stick

Sport Broad Spectrum Spf50+ Water Resistant (80 Minutes) Mineral Sunscreen Uva/uvb Protection Stick
SPL v2
SPL
SPL Set ID 3201cc8b-5fee-4f3b-a826-e349786d1b32
Route
TOPICAL
Published
Effective Date 2022-05-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (200 mg)
Inactive Ingredients
Candelilla Wax Medium-chain Triglycerides Yellow Wax Coconut Oil Myristyl Myristate Shea Butter Tridecyl Salicylate Cocoa Butter Helianthus Annuus Seed Wax .alpha.-tocopherol Acetate Aloe Vera Leaf Sorbitan Monooleate Jojoba Oil Triethoxycaprylylsilane

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-03-08

Description

Zinc Oxide 20.0%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 20.0%

Uses
  • helps prevent sunburn.
  • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer an early skin aging caused by the sun.
Warnings

For external use only.

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 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.

Do Not Use
  • on damaged or broken skin.
Other Information
  • protect the product in this container from excessive heat and direct sun.
Package Labeling:

Active Ingredients

Zinc Oxide 20.0%

Inactive Ingredients

Candelilla Wax, Caprylic/Capric Triglyceride, Cera Alba (Beeswax), Cocos Nucifera (Coconut) Oil, Myristyl Myristate, C18-20 Alkane, Butyrospermum Parkii (Shea) Butter, C13-14 Alkane, Tridecyl Salicylate, Theobroma Cacao (Cocoa) Seed Butter, Helianthus Annuus (Sunflower) Seed Wax, Tocopheryl Acetate, Fragrance (Parfum), Aloe Barbadensis Leaf Juice (Aloe Vera Gel from Aruba), Sorbitan Oleate, Simmondsia Chinensis (Jojoba) Seed Oil, Triethoxycaprylylsilane.

When Using This Product
  • keep out of eyes. Rinse with water to remove.
Stop Use and Ask A Doctor If
  • rash occurs.
Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses
  • helps prevent sunburn.
  • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer an early skin aging caused by the sun.
Purpose

Sunscreen

Warnings

For external use only.

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 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.

Do Not Use (Do not use)
  • on damaged or broken skin.
Other Information
  • protect the product in this container from excessive heat and direct sun.
Package Labeling:

Active Ingredients (Active ingredients)

Zinc Oxide 20.0%

Inactive Ingredients (Inactive ingredients)

Candelilla Wax, Caprylic/Capric Triglyceride, Cera Alba (Beeswax), Cocos Nucifera (Coconut) Oil, Myristyl Myristate, C18-20 Alkane, Butyrospermum Parkii (Shea) Butter, C13-14 Alkane, Tridecyl Salicylate, Theobroma Cacao (Cocoa) Seed Butter, Helianthus Annuus (Sunflower) Seed Wax, Tocopheryl Acetate, Fragrance (Parfum), Aloe Barbadensis Leaf Juice (Aloe Vera Gel from Aruba), Sorbitan Oleate, Simmondsia Chinensis (Jojoba) Seed Oil, Triethoxycaprylylsilane.

When Using This Product (When using this product)
  • keep out of eyes. Rinse with water to remove.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • rash occurs.
Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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