Solar Protection Formula Spf 65
FDA Label NDC 58892-265

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Fallien Cosmeceuticals, Ltd. for the product Solar Protection Formula Spf 65 (NDC 58892-265). 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 other, active ingredients:, purpose, uses:, warnings:, otc - do not use, otc - stop use, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Active Ingredients:

→ Purpose

→ Uses:

→ Warnings:

→ Otc - Do Not Use

→ Otc - Stop Use

→ Otc - When Using

→ Otc - Keep Out Of Reach Of Children

→ Other Information:

→ Directions:

→ Inactive Ingredients:

→ Principal Display Panel – 2 Oz Carton Label

Other

DRUG FACTS

Active Ingredients:

Octinoxate 6%

Octocrylene 7%

Oxybenzone 4%

Titanium Dioxide 4%

Zinc Oxide 5%

Purpose

Sunscreen

Uses:

Helps prevent sunburn. 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.

Warnings:

For external use only.

Otc - Do Not Use

Do not use on damaged or broken skin.

Otc - Stop Use

Stop use and ask a doctor if rash occurs.

Otc - When Using

When using this product, keep out of eyes. Rinse with water to remove.

Otc - Keep Out Of Reach Of Children

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

SHAKE WELL BEFORE USING

Other Information:

Protect this product from excessive heat and direct sun
May stain some fabrics

Directions:

Apply liberally 15 minutes before sun exposure.
Use a water resistant product if swimming or sweating.
Reapply at least every 2 hours.
Children under 6 months: Ask a doctor
Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
- Limit time in the sun, especially from 10:00 a.m.-2 p.m.
- Wear long-sleeved shirts, pants, hats, and sunglasses

Inactive Ingredients:

Acrylates/Octylacrylamide Copolymer, Aluminum Starch Octenylsuccinate, Ascorbyl Palmitate, 5-Bromo-5-Nitro-1, 3-Dioxane, Beta-Carotene, Butylparaben, C12-15 Alkyl Benzoate, Cetearyl Alcohol, Cetearyl Glucoside, Dimethicone, Disodium EDTA, Iron Oxides, Isobutylparaben, Isopropylparaben, Linoleamidopropyl Dimethylamine, Octyldodecyl Neopentanoate, Phenoxyethanol, Pinus Pinaster Bark Extract, Polysorbate 20, Propylene Glycol, Selenium Yeast Extract, Simethicone, Sorbitan Laurate, Talc, Tocopherol, Tocopheryl Acetate, Triethoxycaprylylsilane, Water

Solar Protection Formula combines Titanium Dioxide, Zinc Oxide, and Iron Oxide to form a complete wall of reflection against UVA/UVB damage.

Manufactured exclusively for
Fallien Ltd., West Norriton, PA
Made in USA