Zinka Clear Zinc Oxide Sunscreen Lotion
FDA Label NDC 52993-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Zinka, Inc. for the product Zinka Clear Zinc Oxide Sunscreen (NDC 52993-001). 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, purposes, ​uses, ​warnings, ​when using this product, ​stop use and ask doctor if, ​directions, ​other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Octinoxate 5.0% w/w

Zinc Oxide 4.3% w/w

Octisalate 3.0% w/w

Oxybenzone 2.5% w/w

Purposes

Sunscreen

​Uses

  • Helps prevent sunburn and skin damage caused by UVA/UVB exposure
  • Higher SPF gives more sunburn protection

​Warnings

For external use only

​When Using This Product

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

​Stop Use And Ask Doctor If

  • Rash or irritation develops and lasts

​Directions

  • Apply liberally 20 minutes before sun exposure to dry skin
  • Reapply to dry skin after toweling, swimming or sweating
  • For children under 6 months of age: Ask a doctor

​Other Information

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

​Inactive Ingredients

Water, Isopropyl Myristate, Aloe Barbadensis Leaf Extract, Diisostearoyl Polyglyceryl-3 Diisostearate, Hydrogenated Polyisobutene, Cetyl Dimethicone, Octyl Palmitate, Retinyl Palmitate, Tocopheryl Acetate, Magnesium Sulfate, Propylene Glycol, White Bees Wax, Hydrogenated Castor Oil, Diazolidinyl Urea, Methyparaben, Disodium EDTA, Propylparaben

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