Sheltered Broad Spectrum Spf 55 Sunscreen
FDA Label NDC 68634-050

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Amcol Health & Beauty Solutions, Inc. Dba for the product Sheltered Broad Spectrum Spf 55 Sunscreen (NDC 68634-050). 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:, otc - purpose, directions:, warning:, otc - when using, otc - keep out of reach of children, inactive ingredients:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Active Ingredients:

→ Otc - Purpose

→ Directions:

→ Warning:

→ Otc - When Using

→ Otc - Keep Out Of Reach Of Children

→ Inactive Ingredients:

→ Principal Display Panel - Carton Label

→ Package Label.principal Display Panel

Other

HBS Code (Labeler): FP15501-50.1

Distributor: Derma Faith

Human OTC Drug

Active Ingredients:

Avobenzone 3.0%

Homosalate 10.0%

Octisalate 5.0%

Octocrylene 2.0%

Oxybenzone 6.0%

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Otc - Purpose

sheltered

broad spectrum

spf 55 sunscreen

derma faith

50 ml/1.7 fl oz

sheltered

broad spectrum

spf 55 sunscreen

Directions:

Apply liberally 15 minutes prior to sun exposure to face, neck and areas exposed to the sun. Re-apply after swimming, sweating or after 2 hours.

Warning:

For external use only. UV exposure from the sun increases your risk of skin cancer and early skin aging. To reduce risk, limit time in the sun, wear protective clothing and use a broad spectrum sunscreen of SPF15 of higher.

Otc - When Using

When using this product keep out of eyes. Rinse with water to remove. If rash occurs discontinue use.

Otc - Keep Out Of Reach Of Children

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

Derma Faith, LLC
5701 W. Slaughter Lane
A130 #337
Austin, TX 78749
Made in the U.S.A.
www.dermafaith.com
M050829

This extra care sunscreen features our patented Polargel® UV SPF boosting technology that enables improved sunscreen performance with lower sunscreen actives. Formulated with antioxidants to help fight free radicals, this non-greasy formulation provides broad-spectrum sun protection without feeling thick or oily.

Active ingredients:

Avobenzone 3.0%

Homosalate 10.0%

Octisalate 5.0%

Octocrylene 2.0%

Oxybenzone 6.0%

Inactive Ingredients:

Water, Butylene Glycol, PEG-8, Polyethylene, Dimethicone, Silica, Picea Abies Wood Extract, Sodium Ascorbyl Phosphate, Retinyl Palmitate, Tocopherol, Tocopheryl Acetate, Titanium Dioxide, Aloe Barbadensis Leaf Juice, Bentonite, Methyl Glucose Sesquistearate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Sodium Polyacrylate, Kaolin, Ethylhexylglycerin, Disodium EDTA, Sodium Hydroxide, Chlorphenesin, Phenoxyethanol

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150831

AMCOL Health & Beauty Solutions, Inc. DBA
301 Laser Lane Lafayette, LA 70507 | www.amcolhpc.com
[email protected]