Sunscreen And Amphibious
FDA Label NDC 77714-004

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 Amphibious (NDC 77714-004). 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 10%, Homosalate 15%, Octisalate 5%

Purpose

Sunscreen

Uses

  • helps prevent sunburn
  • if used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only

Do not use on damaged or broken skin

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 product is swallowed, get medial help or contact a poison control center right away

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/Copolymer, Acrylates/C10-30 Alkyl acrylate crosspolymer, carbomer, diisoproyl adipate, dimethyl capramide, disodium EDTA,ethylhexylglycerin, fragrance, hydroxypropyl methylcellulose, macrocystis pyrifera extract, phenoxyethanol, polyster-8, polyisobutene, propylene glycol, silica, sorbitan oleate, Vitamin E, triethanolamine, water

Questions Or Comments?

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

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