Sunscreen
FDA Label NDC 57367-029

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by 220 Laboratories Inc for the product Sunscreen (NDC 57367-029). 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 otc - active ingredient, otc - when using, warnings, otc - ask doctor, storage and handling, dosage & administration, general precautions, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredients                                              Purpose

Butyl Methoxydibenzoylmethane 3.0%................................Sunscreen

Homosalate 15.0%............................................................Sunscreen

Benzophenone-3 5.0%.......................................................Sunscreen

Octocrylene 2.0%..............................................................Sunscreen

Ethylhexyl Salicylate 5.0%.................................................Sunscreen

Otc - When Using

When Using this product

  • Keep out of reach of children
  • Keep out of eyes. Rinse with water to remove.
  • Do not use if allergic to any ingredient.
  • If swallowed, get medical help or contact Poison Control Center immediately.

Warnings

Warnings

  • For external use only
  • Do not spray directly into face
  • Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

Otc - Ask Doctor

Stop use and ask doctor if
  • Rash or irritation develops.

Storage And Handling

Flammable

  • Do not use near heat, open flame or while smoking.
  • Do not puncture or incinerate. Contents under pressure.
  • Do not store at temperature about 120°F (49°C).
  • Avoid long term storage about 104°F (40°C).

Dosage & Administration

Directions

  • Apply generously and evenly to all areas 15 minutes before sun exposure.
  • Spray on hands and apply to face.
  • Use in well-ventilated area.
  • Reapply to dry skin as needed.
  • Ask doctor before use on children under six months of age.

General Precautions

Other Information

Sun Alert: Limiting sun exposure, wearing protective clothing and using sunscreens may reduce the risk of skin aging, skin cancer and other harmful effects of the sun.

Inactive Ingredient

Other Ingredients

Butane, Alcohol Denat., Taploca Starch, Zinc Oxide, Retinyl Palmitate, Zea Mays (Corn) oil, Cholecalciferol, Tocopheryl Acetate, Panthenol, Tetrahexyldecyl Ascorbate, Ascorbyl Palmitate, Acrylates/Octylacylamide Copolymer, Fragrance (Parfum)

Otc - Purpose

Active Ingredients                                               Purpose

Butyl Methoxydibenzoylmethane 3.0%................................Sunscreen

Homosalate 15.0%............................................................Sunscreen

Benzophenone-3 5.0%.......................................................Sunscreen

Octocrylene 2.0%..............................................................Sunscreen

Ethylhexyl Salicylate 5.0%.................................................Sunscreen

Package Label.Principal Display Panel

Zinka Clear continuous sunscreen sprayMega mist water resistantBroad spectrumUVA/UVB ProtectionNon-greasy, no slip gripFast and even application

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