H.e.b Lotion
FDA Label NDC 37808-956

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 37808-956). 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

Acobenzone 2.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 7.0%, Oxybenzone 6.0%

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.

Otc - Ask Doctor

Stop use and ask 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 aging. To decrease this risk, regularly use a sunscreen with a broad-spectrum of 15 or higher and other sun protection measures including:

      •    • limit time in the sun, especially from 10am-2pm

         • 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, propylene glycol, silica, aluminum starch octenylsuccinate, behenyl alcohol, butylated PVP, glyceryl stearate, microcrystalline cellulose, benzyl alcohol, palmitic acid, myristyl alcohol, stearic acid, saccharomyces/podophyllum peltatum ferment filtrate, lauryl alcohol, cetyl alcohol, aloe barbadensis leaf juice, chamomilla recutita (matricaria) flower extract, tocopherol (vitamin E), lecithin, cellulose gum, chlorphenesin, disodium EDTA, butylene glycol

Questions Or Comments?

Call toll free 1-800-527-7731

Package Label.Principal Display Panel

H.E.B Solutions Sunscreen Ultra SPF 50 Lotion

3 FL OZ (89mL)

NDC 37808-956-09

Label (37808 956 09)

Label (37808 956 09)

H.E.B Solutions Sunscreen Ultra SPF 50 Lotion

8 FL OZ (237mL)

NDC 37808-956-12

Label (37808 956 12)

Label (37808 956 12)

* Please review the disclaimer below.