Total Protector Color 30 Medium Tint
FDA Label NDC 66078-504

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Md Formulation for the product Total Protector Color 30 Medium Tint (NDC 66078-504). 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, indications & usage, warnings, otc - stop use, otc - keep out of reach of children, inactive ingredient, otc - purpose, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredient                        Purpose

Zinc Oxide  - 7.8%                     Sunscreen
Octinoxote  - 7.5%                     Sunscreen
Octisalate   - 4.0%                     Sunscreen

Indications & Usage

When using this product do not use in or near the eyes. If product gets into eyes, rinse thoroughly with water.

Warnings

Warnings For external use only.

Otc - Stop Use

Stop use and ask a doctor if Irritation of rash appears and lasts.

Otc - Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Polson Control Center right away .

Inactive Ingredient

Inactive ingredients Purified Waler (Aqua), C 12-15 Alkyl Benzoate,  Glyceryl Stearate, Glycerin,Steareth-2, Steareth-100, TricontanylPVP, PEG-100 Stearate, Tocopheryl Acetate,  Allantoin, Dimethicone, Xanthan Gum, Cetyl Hydroxyethylcellulose, Disodium EDTA, Diazolidinyl Urea, Iodopropynl Butylcarbamate, Phenoxyethanol, Methylparaben, Propylparaben, Mica(CI 77019), Bismuth Oxychloride (CI 77163), Iron Oxides (CI 77489)

Otc - Purpose

Active Ingredient                        PurposeZinc Oxide  - 7.8%                     SunscreenOctinoxote  - 7.5%                     SunscreenOctisalate   - 4.0%                     Sunscreen

Dosage & Administration

Directions Children under 2 years of age should use sunscreen products with a minimum SPF of 4. Adults and children 6 months and over; apply liberally 15 minutes before sun or water exposure; reapply after swimming or excessive sweating or anytime after towel drying. Children under 6 months ask a doctor.

* Please review the disclaimer below.