Skinpharmacy Advanced Sun Therapy Broad Spectrum Spf 50 Face
FDA Label NDC 68634-053

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 Skinpharmacy Advanced Sun Therapy Broad Spectrum Spf 50 Face (NDC 68634-053). 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

→ Directions

→ Other Information

→ Inactive Ingredients

→ Principal Display Panel - Carton Label

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Other

Drug Facts

Active Ingredients

Avobenzone 3.0%

Homosalate 10.0%

Octisalate 5.0%

Octocrylene 2.0%

Oxybenzone 6.0%

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

Directions

Apply liberally 15 minutes before sun exposure
reapply:
- after 80 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours

Other Information

Protect the product in this container from excessive heat and direct sunlight.

Inactive Ingredients

Water, Butylene Glycol, PEG-8, Polyethylene, Dimethicone, Silica, Picea Albies 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.

Polargel^® is a registered trademark of AMCOL International Corp.

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2016 CVS/pharmacy CVS.com^® 1-800-SHOP CVS

Made in the U.S.A. of U.S.
and imported components
V-32991
CVS^® Quality
Money Back Guarantee
M050912CP
FP155

________________________________________________________

end of text

160225

AMCOL Health & Beauty Solutions, Inc. DBA AMCOL Household and Personal Care

301 Laser Lane Lafayette, LA 70507 | www.amcolhpc.com

[email protected]

Principal Display Panel - Carton Label

SKIN-PHARMACY^® ADVANCED SUN THERAPY

BROAD SPECTRUM SPF 50 FACE LOTION

UVA/UVB protection with Polargel^® UV Technology

Sunscreen with antioxidant Vitamin A & Picea Albies Wood Extract for protection against free radicals

Polargel^® UV Technology allows lower sunscreen actives & optimizes performance

moisturizing, non-whitening formula with broad spectrum protection

water resistant (80 minutes)

paraben, oil & fragrance free

DERMATOLOGIST TESTED

exclusively at CVS/pharmacy

Actual Product Size on Side Panel

3 FL OZ (90 mL)

Principal Display Panel (Carton Label)

Principal Display Panel - Tube Label