Heb Solutions Sunscreen Face 50 Facial Mist Sunscreen Spray
FDA Label NDC 37808-127

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by H.e.b for the product Heb Solutions Sunscreen Face 50 Facial Mist Sunscreen (NDC 37808-127). 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, flammable:, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredients

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 2.5%

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

Flammable:

   • do not use near heat, flame or while smoking

   • avoid long term storage above 104°F (40°C)

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 right away.

Directions

  • shake bottle vigorously before each use.
  • apply liberally and evenly 15 minutes before sun exposure.
  • hold bottle 6-8 inches away from face, pull hair back, close eyes, tuck lips, then spray at least 7-10 times in a circle to ensure complete coverage. Keep eyes closed for about 3 seconds after application.
  • 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 the product in this container from excessive heat and direct sun
  • may stain or damage some fabrics, materials or surfaces
  • may temporarily sting

Inactive Ingredients

acrylates/octylacrylamide copolymer, aloe barbadensis leaf juice, butyloctyl salicylate, caprylic/capric triglyceride, fragrance, glycerin, isododecane, panthenol, SD alcohol 40-B, silica silylate, tocopherol.

Label

Heb17800e1 (Heb17800e1)

Heb17800e1 (Heb17800e1)

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