Bull Frog Spf 50 Mosquito Coast Sunscreen Plus Inspect Repellent Spray

Bull Frog Spf 50 Mosquito Coast Sunscreen Plus Inspect Repellent Spray
SPL v2
SPL
SPL Set ID f70b39c6-9f40-f5c1-e053-6394a90a1d43
Route
TOPICAL
Published
Effective Date 2023-01-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Homosalate (100 mg) Octisalate (50 mg) Octocrylene (75 mg) Octinoxate
Inactive Ingredients
Aloe Vera Leaf Alkyl (c12-15) Benzoate .alpha.-tocopherol Acetate, D- Mineral Oil Acrylate/isobutyl Methacrylate/n-tert-octylacrylamide Copolymer (75000 Mw) Soybean Oil Alcohol Ethyl Butylacetylaminopropionate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-04-26

Description

Avobenzone 3.0%, Octocrylene 5%, Homosalate 10.0%, Octyl Methoxycinnamate 7.5%, Octisalate 5%

Purpose

Sunscreens


Medication Information

Purpose

Sunscreens

Description

Avobenzone 3.0%, Octocrylene 5%, Homosalate 10.0%, Octyl Methoxycinnamate 7.5%, Octisalate 5%

Uses
  • helps prevent sunburn
Label

Warnings

Skin Alert • Limiting sun exposure, wearing protective clothing, and using sunscreen may reduce the risk of skin aging, skin cancer and other harmful effects of the sun

For external use only

Flammable:

• do not use near heat, flame or while smoking

• avoid long term storage above 104°F (40°C)

• do not puncture or incinerate

• contents under pressure

• do not store at temperatures above 120°F (49°C).

Do Not Use

• on damaged or broken skin.

directions
  • apply liberally 15 minutes before sun exposure
  • reapply:

• after 80 minutes of swimming or sweating

• immediately after towel drying

• at least every 2 hours

  • children under 6 months of age: Ask a doctor
Other Information

• Protect the product in this container from excessive heat and direct sun.

Active Ingredients

Avobenzone 3.0%, Octocrylene 5%, Homosalate 10.0%, Octyl Methoxycinnamate 7.5%, Octisalate 5%

Inactive Ingredients

Acrylates/Octylacrylamide Copolymer, SD Alcohol 40 (47% w/w), Aloe Barbadensis Leaf Oil, C12-15 Alkyl Benzoate, Fragrance, Tocopheryl (Vitamin E) Acetate.

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
Label

Purpose

Sunscreens

Warnings

Skin Alert • Limiting sun exposure, wearing protective clothing, and using sunscreen may reduce the risk of skin aging, skin cancer and other harmful effects of the sun

For external use only

Flammable: (FLAMMABLE:)

• do not use near heat, flame or while smoking

• avoid long term storage above 104°F (40°C)

• do not puncture or incinerate

• contents under pressure

• do not store at temperatures above 120°F (49°C).

Do Not Use (Do not use)

• on damaged or broken skin.

directions (Directions)
  • apply liberally 15 minutes before sun exposure
  • reapply:

• after 80 minutes of swimming or sweating

• immediately after towel drying

• at least every 2 hours

  • children under 6 months of age: Ask a doctor
Other Information (Other information)

• Protect the product in this container from excessive heat and direct sun.

Active Ingredients (Active ingredients)

Avobenzone 3.0%, Octocrylene 5%, Homosalate 10.0%, Octyl Methoxycinnamate 7.5%, Octisalate 5%

Inactive Ingredients (Inactive ingredients)

Acrylates/Octylacrylamide Copolymer, SD Alcohol 40 (47% w/w), Aloe Barbadensis Leaf Oil, C12-15 Alkyl Benzoate, Fragrance, Tocopheryl (Vitamin E) Acetate.

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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