Theraderm Platinum Protection Facial Sunscreen Spf 40 Lotion
FDA Label NDC 66428-567

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Therapon Inc for the product Theraderm Platinum Protection Facial Sunscreen Spf 40 (NDC 66428-567). 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, purpose, uses, do not use, when using this product, stop use and ask a doctor, keep out of reach of children., if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Octocrylene 10.00%

Octisalate 5.00%

Zinc oxide 4.00%

Purpose

Sunscreen

Uses

Helps prevent sunburn. Higher SPF gives more sunburn protection. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Do Not Use

  • on damaged or broken skin.

When Using This Product

  • keep out of eyes. • Rinse with water to remove.• Do not puncture or incinerate. Contents underpressure. • Do not store it at temperatures above 120°F.

Stop Use And Ask A Doctor

  • if rash or irritation develops and lasts.

Keep Out Of Reach Of Children.

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

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Directions

Apply liberally 15 minutes before sun exposure and as needed. Children under 6 months of age: ask a doctor. Reapply: after 80 minutes of swimming or sweating, immediately after towel drying, and at least every 2 hours. Use a water-resistant sunscreen if swimming or sweating. Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 a.m. - 2 p.m. Wear long-sleeved shirts, pants, hats, and sunglasses. 

Inactive Ingredients

Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Ascorbyl Palmitate (Vitamin C), Butyloctyl Salicylate, Camellia Sinensis (Green Tea) Extract, Caprylic/ Capric Triglyceride, Cetearyl Alcohol, Cetearyl Glucoside, Cetyl Alcohol, Citric Acid, Cocos Nucifera (Coconut) Oil, Ethylhexylglycerin, Glyceryl Stearate SE, Isododecane, C13-14 Isoparaffin, Laureth-7, dl-Panthenol, Phenoxyethanol, Polyacrylamide, Polysorbate-20, Sodium Hyaluronate, Squalane, Stearyl Alcohol, Tocopheryl Acetate (Vitamin E), Trimethylsiloxysilicate, Zemea (Corn) Propanediol.

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