Solar Protection Formula Spf 60 Tinted Concealer - (beige)
FDA Label NDC 58892-721

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 60 Tinted Concealer - (beige) (NDC 58892-721). 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

DRUG FACTS

Active Ingredients:

Octinoxate 6%

Octocrylene 7%

Oxybenzone 4%

Titanium Dioxide 10%

Zinc Oxide 3.4%

Purpose

Sunscreen

Sunscreen

Sunscreen

Sunscreen

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, Caramel, Beta-Carotene, Butylparaben, C12-15 Alkyl Benzoate, Cetearyl Alcohol, Cetearyl Glucoside, Disodium EDTA, Iron Oxides, Isobutylparaben, Isopropylparaben, Linoleamidopropyl Dimethylamine, Methylparaben, Octyldodecyl Neopentanoate, Phenoxyethanol, Pinus Pinaster Bark Extract, Polysorbate 20, Propylene Glycol, Simethicone, Sorbitan Laurate, Talc, Tocopherol, Tocopheryl Acetate, Triethoxycaprylylsilane, Water

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

Solar Protection Formula offers the most complete protection from UVB/UVA available, and is essential for the medically light sensitive and for those concerned with the damaging effects of the sun.

Principal Display Panel – Beige Carton Label

SOLAR

PROTECTION

FORMULA®

TINTED
CONCEALER

SPF 60

Broad Spectrum

UVA/UVB

2 Fl.Oz./59 ml

Principal Display Panel – Beige Carton Label (Sol02 0002 01)

Principal Display Panel – Beige Carton Label (Sol02 0002 01)

Principal Display Panel – Honey Carton Label

SOLAR

PROTECTION

FORMULA®

TINTED
CONCEALER

SPF 60

Broad Spectrum

UVA/UVB

2 Fl.Oz./59 ml

Principal Display Panel – Honey Carton Label (Sol02 0002 02)

Principal Display Panel – Honey Carton Label (Sol02 0002 02)

Principal Display Panel – Blush Carton Label

SOLAR

PROTECTION

FORMULA®

TINTED
CONCEALER

SPF 60

Broad Spectrum

UVA/UVB

2 Fl.Oz./59 ml

Principal Display Panel – Blush Carton Label (Sol02 0002 03)

Principal Display Panel – Blush Carton Label (Sol02 0002 03)

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