H.e.b Aerosol, Spray
FDA Label NDC 37808-984

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 (NDC 37808-984). 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.

Label Section Quick Index

Active Ingredients

Avobenzone 3.0%, Homosalate 13.0%, Octisalate 5.0%, Octocrylene 2.0%, Oxybenzone 4.0%

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

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. • do not puncture or incinerate. Contents under pressure. • do not store at temperatures above 120°F.

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
  • 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 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 Ingredients

water, sorbitol, VP/eicosene copolymer, stearic acid, styrene/acrylates copolymer, aloe barbadensis leaf juice, triethanolamine, sorbitan isostearate, chamomilla recutita (matricaria) flower extract, propylene glycol, benzyl alcohol, dimethicone, tocopherol (vitamin E), polyglyceryl-3 distearate, acrylates/C10-30 alkyl acrylate crosspolymer, disodium EDTA, phenoxyethanol, capryloyl glycine, undecylenoyl glycine

Questions Or Comments?

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Package Label.Principal Display Panel

H.E.B Solutions Sunscreen Baby SPF 50 Lotion Spray

6.3 OZ (178g)

NDC 37808-984-50

Label (Label)

Label (Label)

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