Face Cream 50
FDA Label NDC 69039-661

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 Face Cream 50 (NDC 69039-661). 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

Homosalate 10%, Octisalate 5%

Octocrylene 10%, Zinc oxide 7%

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.

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

• shake well before use

• 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

Inactive Ingredients

water, C12-15 alkyl benzoate, ethylhexyl palmitate, ethylhexyl stearate, cetyl peg/ppg-10/1 dimethicone, glycerin, hydrogenated castor oil, isoamyl cocoate, hydrogenated ethylhexyl olivate, hydrated silica, polyethylene, tocopheryl acetate, theobroma cacao seed butter, aloe barbadensis leaf juice, beeswax, hydrogenated olive oil unsaponifiables, fragrance, sodium chloride, triethoxycaprylysilane, phenoxyethanol, ethylhexylglycerin

Other Information

• protect this product from excessive heat and direct sun
• keep outer card for complete directions and warnings

Questions?

1-877-978-6286

* Please review the disclaimer below.