Sun Bum Hand Cream Spf15
FDA Label NDC 69039-637

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sun Bum Llc for the product Sun Bum Hand Cream Spf15 (NDC 69039-637). 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, 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

Avobenzone 2%,

Homosalate 5%,

Octisalate 2%,

Octocrylene 10%

Purpose

Sunscreen

Uses

  • helps prevent sunburn
  • Keep outer carton for full information
  • 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

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 swallowed, get medical help or contact a Poison Control Center immediately.

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

    • 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 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-sleeved shirts, pants, hats and sunglasses

Other Information

protect this product from excessive heat and direct sun

Inactive Ingredients

water, isoamyl cocoate, cetearyl alcohol, arachidyl alcohol, dimethicone, glycerin, behenyl alcohol, styrene/acrylates copolymer, cetearyl glucoside, arachidyl glucoside, fragrance, polyester-8, saccharide isomerate, aprylyl glycol, phenoxyethanol, sorbic acid, xanthan gum xanthan gum, phenoxyethanol, ethylhexylglycerin

Questions?

1-877-978-6286

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