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

Purpose

Sunscreens

Description

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


Medication Information

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

Uses
  • helps prevent sunburn
Purpose

Sunscreens

Other Information

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

Inactive Ingredients

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

Description

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

Label

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
Active Ingredients

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

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

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

Uses
  • helps prevent sunburn
Purpose

Sunscreens

Other Information (Other information)

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

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.

Label

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
Active Ingredients (Active ingredients)

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

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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