Sunscreen And Insect Repellent Solution
FDA Label NDC 77714-005

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Bullfrog Brands, Llc for the product Sunscreen And Insect Repellent (NDC 77714-005). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, flammable:, otc - do not use, otc - when using, otc - ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

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

Purpose

Sunscreen

Uses

  • helps prevent sunburn

Warnings

For external use only

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

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).

Otc - Do Not Use

Do not use • on damaged or broken skin.

Otc - When Using

When using this product • keep out of eyes. Rinse with water to remove.

Otc - Ask Doctor

Stop use and ask a doctor if • rash occurs.

Otc - 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.

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.

Inactive Ingredients

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

Questions Or Comments?

www.bullfrogsunscreen.com or call toll-free 1-800-990-FROG

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