Walgreens Sunscreen
FDA Label NDC 0363-4016

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Walgreen Co. for the product Walgreens Sunscreen (NDC 0363-4016). 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, do not use, when using this product, stop use and ask a doctor, 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 10.0%

Octisalate 5.0%

Octocrylene 10.0%

Purpose

Sunscreen

Uses

  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions) decrease the risk of skin cancer and early skin aging caused by the sun

Warnings

For External use only


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 product is swallowed get medical help or contact a Poison Control Center right away.

  • May stain some fabrics.

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

    • Sun protection measures.

    Spending time in the sun increase 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 am - 2 pm
    • Wear long sleeves shirts, pants, hats and sunglasses
    • children under 6 month of age: Ask a doctor

Inactive Ingredients

Water, Ethylhexyl Palmitate, Sorbitol, Polyglyceryl-3 Methylglucose Distearate, Diethylhexyl Syringylidenemalonate, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Glyceryl Stearate, PEG-100 Stearate, Caprylic/ Capric Triglyceride, Disodium EDTA, Oleth-3, Tocopherol, Aloe Barbadensis Leaf Juice Powder, Sodium Ascorbyl Phosphate, Benzyl Alcohol, Chlorphenesin, Fragrance.


Other Information

Protect this product from excessive heat and direct sun. 

Questions Or Comments

1-800-WALGREENS (1-800-925-4733) 

Principal Display Panel

NDC 0363-4016-29

VALUE SIZE

Well at

Walgreens

LOTION

Sunscreen

Broad Spectrum SPF 30

  • Water resistant (80 minutes)
  • UVA/UVB protection

    • 16 FL OZ (473 mL)

    Label29 (401629)

    Label29 (401629)




    NDC 0363-4016-22

    Well at Walgreens

    WALGREENS PHARMACIST RECOMMENDED

    SUNSCREEN

    Lotion

    Broad Spectrum SPF 30

    • Water resistant (80 minutes)
    • UVA/UVB protection

      • 30

      10 FL OZ (296 mL)

      Label22 (401622)

      Label22 (401622)




      NDC 0363-4016-19

      Well at Walgreens

      WALGREENS PHARMACIST RECOMMENDED

      SUNSCREEN

      Lotion

      Broad Spectrum SPF 30

      • Water resistant (80 minutes)
      • UVA/UVB protection

        • 30

        3 FL OZ (88 mL)

        Label19 (401619)

        Label19 (401619)

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