Sunny Sailor First Mate Face Stick Spf 30

Sunny Sailor First Mate Face Stick Spf 30
SPL v1
SPL
SPL Set ID 8ef7e0c8-e76b-4e84-ac9d-169f85e5e36e
Route
TOPICAL
Published
Effective Date 2025-05-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (180 mg)
Inactive Ingredients
Olive Oil Yellow Wax Jojoba Oil Cocoa Butter Shea Butter .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-09

Description

Zinc Oxide 18%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 18%

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
Warnings

For external use only

Directions
  • Apply liberally 15 minutes before sun exposure and as needed.
  • Children under 6 months of age: ask a doctor.
  • 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 the risk, regularly use a sunscreen with broad spectrum SPF 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.
Do Not Use
  • on damaged or broken skin.
Drug Facts

Active Ingredient

Zinc Oxide 18%

Other Information
  • Protect the product in this container from excessive heat and direct sun.
Package Labeling:

Inactive Ingredients

Olea Europaea (Olive) Fruit Oil, Beeswax, Simmondsia Chinensis (Jojoba) Seed Oil, Theobroma Cacao (Cocoa) Seed Butter, Butyrospermum Parkii (Shea) Butter, Tocopheryl Acetate (Vitamin E).

When Using This Product
  • keep out of eyes. Rinse with water to remove.
Stop Use and Ask A Doctor If
  • rash or irritation develops and lasts.
If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center immediately


Structured Label Content

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

Sunscreen

Warnings

For external use only

Directions
  • Apply liberally 15 minutes before sun exposure and as needed.
  • Children under 6 months of age: ask a doctor.
  • 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 the risk, regularly use a sunscreen with broad spectrum SPF 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.
Do Not Use (Do not use)
  • on damaged or broken skin.
Drug Facts

Active Ingredient

Zinc Oxide 18%

Other Information (Other information)
  • Protect the product in this container from excessive heat and direct sun.
Package Labeling:

Inactive Ingredients

Olea Europaea (Olive) Fruit Oil, Beeswax, Simmondsia Chinensis (Jojoba) Seed Oil, Theobroma Cacao (Cocoa) Seed Butter, Butyrospermum Parkii (Shea) Butter, Tocopheryl Acetate (Vitamin E).

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 or irritation develops and lasts.
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center immediately


Advanced Ingredient Data


Raw Label Data

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