H.e.b Baby Aerosol, Spray
FDA Label NDC 37808-913

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 H.e.b Baby (NDC 37808-913). 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, otc - do not use, otc - when using, otc - ask doctor, otc - keep out of reach of children, 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 4.5%, Octocrylene 8.0%

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

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 - Ask Doctor

Stop use and ask a doctor if • rash occurs.

Otc - Keep Out Of Reach Of Children

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
  • 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 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-sleeve shirts, pants, hats, and sunglasses

Other Information

  • protect this product from excessive heat and direct sun
  • may stain or damage some fabrics, materials or surfaces

Inactive Ingredient(S)

water, butyloctyl salicylate, butylene glycol, glyceryl stearate, microcrystalline cellulose, behenyl alcohol, butylated PVP, stearic acid, lauryl alcohol, myristyl alcohol, cetyl alcohol, caprylic/capric triglyceride, tocopherol, sodium ascorbyl phosphate, cellulose gum, disodium EDTA, benzoic acid, benzoic alcohol, sorbic acid.

Questions Or Comments?

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Package Label.Principal Display Panel

H-E-B SOLUTIONS SUNSCREEN BABY SPF 50 LOTION

8 FL OZ (237mL)

NDC 37808-913-12

Label (Label)

Label (Label)

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