Coppertone Clearly Sheer Whipped Sunscreen Broad Spectrum Spf 50 Lotion
FDA Label NDC 23667-800

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Formulated Solutions, Llc for the product Coppertone Clearly Sheer Whipped Sunscreen Broad Spectrum Spf 50 (NDC 23667-800). 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, do not use on, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

(To Deliver) Avobenzone 3%, Homosalate 10%, Octisalate 4.5%,
Octocrylene 4%, Oxybenzone 6%

Purpose

Sunscreen

Uses

  • helps prevent sunburn
  • if used as directed with other sun protection increases (see Directions), 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.
  • use only as directed. Intentional misue by deliberately concentrating and inhaling the contents can be harmful or fatal.
  • do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F.

Stop Use And Ask A Doctor If

rash occurs

Keep Out Of Reach Of Children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • apply liberally 15 minutes before sun exposure
  • do not dispense or apply directly on face. Dispense into hands and apply to face
  • use in well-ventillated areas
  • reapply:
  • after 80 minutes if swimming or sweating
  • imediately 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 this risk, regularly use a sunscereen with a Broad Spectrum SPF value 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-sleeve shirts, pants, hats, and sunglasses
  • children under 6 months: Ask a doctor

Other Information

  • protect this product from excessive heat and direct sun
  • avoid long term storage above 40°C (104°F)
  • may stain or damage some fabrics or surfaces

Inactive Ingredients

Water, Aluminum Starch Octenylsuccinate, Behenyl Alcohol, Glycerin, Styrene/Acrylates Copolymer, Dicaprylyl Ether, Microcrystalline Cellulose, Glyceryl Stearate, Cetyl Alcohol, Benzyl Alcohol, Butylated PVP, Palmitic Acid, Stearic Acid, Myristyl Alcohol, Chlorphenesin, Tocopherol (Vitamin E), Cellulose Gum, Lecithin, Disodium EDTA, Lauryl Alcohol, Sodium Ascorbyl Phosphate, Fragrance, Nitrous Oxide.

Questions?

1-866-288-330

Package Labeling:

Coppertone (Coppertone)

Coppertone (Coppertone)

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