Exchange Select Baby Sunscreen
FDA Label NDC 55301-006

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Army And Air Force Exchange Service for the product Exchange Select Baby Sunscreen (NDC 55301-006). 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, when using this product, stop use and ask a doctor if, keep out of reach of children., do not use on, 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 %

Homosalate 13.0%

Octisalate 5.0%

Octocrylene 7.0%

Oxybenzone 4.0%

Purpose

Sunscreen

Uses

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

Warnings

For external use only

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 medical help or contact a Poison Control Center right away. May stain some fabrics.

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
  • 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 sunscreen with a broad spectrum SPF 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 of age: Ask a doctor

Other Information

  • protect this product from excessive heat and direct sun

Inactive Ingredients

Water, Sorbitol, Stearic Acid, Triethanolamine, Aluminum Starch Octenylsuccinate, Benzyl Alcohol, Sorbitan Isostearate, VP/Eicosene Copolymer, Dimethicone, Polyglyceryl-3 Distearate, Carbomer, Tocopherol, Disodium EDTA, Methylparaben, Propylparaben, Fragrance.


Principal Display Panel

exchange

select

X

BABY

SUNSCREEN

lotion

50

BROAD SPECTRUM

SPF 50

UVA/UVB Protection

Water Resistant

(80 Minutes)

Pediatrician Tested

8 FL. OZ. (236 mL)

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