Total Protrector 15
FDA Label NDC 66078-110

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 Protrector 15 (NDC 66078-110). 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, dosage & administration, other, 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

Octinoxate - 7.5%             SunscreenZink Oxide - 4.9%             Sunscreen

Indications & Usage

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

Warnings

Warnings: For external use only.

Otc - Stop Use

Stop use and ask a doctor if Irritation or rash appears and lasls.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed , get medical help or contact a Poison Control Center right away.

Dosage & Administration

Directions: Children under 2 years of age should use sunscreen products with a minimum SPF of 4. Adult 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.

Other

Other information store at 20.25C (68-770 F) Sun Alert: The sun causes sun damage. Regular use of sunscreens over the years may reduce the chance of skIn damage, some types of skin cancer, and other harmful effects due to the sun.

Inactive Ingredient

Inactive ingredients: Water (Aqua), Glyceryl Stearate, C12-15 Alkyl Benzoate, GlycerIn, Steareth-2, Steareth-100, Tricontanyl PVP, PEG-100 Stearate, Tocopheryl Acetate, Allantoin, Xanthan Gum, Cetyl Hydroxyelhylcellulose, Dimethicone, Disodium EDTA, Diazolidinyl Urea, lodopropynyl Butylcarbamate, Methylparaben. Propylparaben.

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