Fresh Skin Effortless Beauty Balm Broad Spectrum Spf 35
FDA Label NDC 43072-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Aerin Lauder Beauty Dist. for the product Fresh Skin Effortless Beauty Balm Broad Spectrum Spf 35 (NDC 43072-001). 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 other, otc - purpose, use, warnings, otc - do not use, otc - when using, otc - stop use, otc - 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

Other

Drug Facts

Otc - Purpose

Active ingredientsPurpose
Octinoxate 7.50%Sunscreen
Octisalate 4.00%Sunscreen
Oxybenzone 2.50%Sunscreen
Titanium Dioxide 1.10%Sunscreen
Zinc Oxide 3.30%Sunscreen

Use

helps prevent sunburn

Warnings

For external use only

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 - Stop Use

Stop use and ask a doctor if rash occurs

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

For sunscreen use:

  • apply liberally 15 minutes before sun exposure
  • reapply at least every two hours
  • use a water resistant sunscreen if swimming or sweating
  • 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
    • children under 6 months of age: ask a doctor

Inactive Ingredients

water\aqua\eau • dimethicone • butylene glycol • phenyl trimethicone • pentylene glycol • glyceryl stearate • behenyl alcohol • trioctyldodecyl citrate • polymethylsilsesquioxane • octyldodecyl stearoyl stearate • peg-40 stearate • polyglyceryl-10 pentastearate • tocopheryl acetate • sodium hyaluronate • lecithin • squalane • triticum vulgare (wheat) germ extract • hordeum vulgare (barley) extract\extrait d'orge • cucumis sativus (cucumber) fruit extract • laminaria saccharina extract • pyrus malus (apple) fruit extract • scutellaria baicalensis root extract • glycerin • caffeine • cholesterol • oryzanol • trehalose • octyldodecyl neopentanoate • polyglyceryl-6 polyricinoleate • acetyl hexapeptide-8 • sodium pca • sucrose • urea • polyquaternium-51 • sodium stearoyl lactylate • ammonium acryloyldimethyltaurate/vp copolymer • polysorbate 20 • sorbitan laurate • propylene glycol laurate • glycyrrhetinic acid • linoleic acid • stearic acid • xanthan gum • silica • isopropyl titanium triisostearate • alumina • propylene glycol stearate • disodium edta • sodium dehydroacetate • chlorphenesin • phenoxyethanol • [+/- mica • iron oxides (ci 77491) • iron oxides (ci 77492) • iron oxides (ci 77499) • titanium dioxide (ci 77891)] <iln41064>

Other Information

protect the product in this container from excessive heat and direct sun

Principal Display Panel - 50 Ml Tube Carton

AERIN

FRESH SKIN
EFFORTLESS BEAUTY BALM
BROAD SPECTRUM SPF 35

1.7 FL. OZ. LIQ/50ml e

Principal Display Panel (50 ml Tube Carton)

Principal Display Panel (50 ml Tube Carton)

* Please review the disclaimer below.