Active Skin Repair Hydrating Daily Sunscreen Lotion
FDA Label NDC 70489-1615

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Innovacyn, Inc. for the product Active Skin Repair Hydrating Daily Sunscreen (NDC 70489-1615). 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 ingredient, purpose, uses, warnings, directions, other information, inactive ingredients, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Zinc oxide, 19.6 %

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 useon damaged or broken skin
When using this productkeep out of eyes. Rinse with water to remove
Stop use and ask a doctor ifrash occurs
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • apply liberally and evenly 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a water-resistant sunscreen if 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 the product in this container from excessive heat and direct sun

Inactive Ingredients

water, C13-15 alkane, butyloctyl salicylate, ethylhexyl olivate, glycerin, zea mays (corn) starch, argania spinosa kernel oil, propanediol, tocopheryl acetate, polyhydroxystearic acid, inulin lauryl carbamate, pentylene glycol, 1,2-hexanediol, betaine, biosaccharide gum-4, bisabolol, cellulose, ethylhexylglycerin, eugenia caryophyllus (clove) bud extract, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, lauroyl lysine, niacinamide, panthenol, phenoxyethanol, polyglyceryl-2 dipolyhydroxystearate, polyglyceryl-3 diisostearate, silica, sodium acrylates crosspolymer-2, sodium hyaluronate, solidago virgaurea (goldenrod) extract, sorbitan isostearate, squalane, tocopherol, trisodium ethylenediamine disuccinate

Product Label

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