Heb Spf 50 Birthday Cake Continuous Sunscreen Spray
FDA Label NDC 37808-088

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 Spf 50 Birthday Cake Continuous Sunscreen (NDC 37808-088). 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 4.0%

Purpose

Sunscreen

Uses

  • helps prevent sunburn
  • if used as directed with other sun protetion 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 stoage 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. • do not puncture or incinerate. Contents under pressure. • do not store at temperatures above 120°F.

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

  • apply liberally 15 minutes before sun exposure
  • hold can 4-6 inches away from body, spray evenly to ensure complete coverage
  • do not spray into face. Spray into hand and apply to face.
  • use in well ventilated, but not windy areas
  • 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.

      • wearl 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

Inactive Ingredients

acrylates/octylacrylamide copolymer, butylene glycol, butyloctyl salicylate, caprylic/capric triglyceride, fragrance, glycerin, panthenol, saccharomyces/podophyllum peltatum ferment filtrate, SD alcohol 40-B, stearoxytrimethylsilane, tocopherol.

Label

Heb73311d1 (Heb73311d1)

Heb73311d1 (Heb73311d1)

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