Suntan Lotion
FDA Label NDC 49852-201

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Tri-coastal Design Company Inc. for the product Suntan Lotion (NDC 49852-201). 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 ingredient, purpose, uses, warnings, stop use and ask a doctor if, keep out of reach of children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Octyl Methoxycinnamate 7%

Oxybenzone 6%

Titanium Dioxide 1%



Purpose

Sunscreen

Uses

  • Helps prevent sunburn

Warnings

  • Keep out of eyes. If contact occurs, rinse thoroughly with water.

Stop Use And Ask A Doctor If

  • irritation develops

Keep Out Of Reach Of Children

  • If swallowed, get medical help promptly or contact Poison Control immediately.

Directions

  • Apply generously and evenly before sun exposure. Reapply as needed or after towel drying, swimming or perspiring. Ask doctor before use on children under 6 months of age

Inactive Ingredients

Caprylic/Capric Triglyceride, Cetearyl Alcohol, Cylcomethicone, DC Orange 4, Disodium EDTA, FDC Blue 1, FDC Yellow 5, Fragrance, Glycerin, Imidazolidinyl Urea, Isopropyl Myristate, Methylparaben, Potassium Cetyl Phosphate, Propylparaben, Tocopheryl Acetate, Water ( Aqua), Xanthan Gum

Package Label

Package Label

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