SKINPHARMACY ADVANCED SUN THERAPY BROAD SPECTRUM SPF 50 FACE- homosalate, oxybenzone, octisalate, avobenzone, octocrylene liquid

SkinPharmacy Advanced Sun Therapy Broad Spectrum SPF 50 Face by

Drug Labeling and Warnings

SkinPharmacy Advanced Sun Therapy Broad Spectrum SPF 50 Face by is a Otc medication manufactured, distributed, or labeled by AMCOL Health & Beauty Solutions, Inc. DBA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Avobenzone 3.0%

Homosalate 10.0%

Octisalate 5.0%

Octocrylene 2.0%

Oxybenzone 6.0%

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 cause by the sun.

Warnings

For external use only.

Do not use on damaged or broken skin.

Stop use and ask a doctor if rash occurs.

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

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

lauren.haase@amcol.com

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 - Tube 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

3 FL OZ (90 mL)

INGREDIENTS AND APPEARANCE

SKINPHARMACY ADVANCED SUN THERAPY BROAD SPECTRUM SPF 50 FACE 
homosalate, oxybenzone, octisalate, avobenzone, octocrylene liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68634-053
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	homosalate	100 g  in 2 mL
oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	oxybenzone	60 g  in 2 mL
octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	octisalate	50 g  in 2 mL
avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	avobenzone	30 g  in 2 mL
octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	octocrylene	20 g  in 2 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
butylene glycol (UNII: 3XUS85K0RA)
polyethylene glycol 400 (UNII: B697894SGQ)
high density polyethylene (UNII: UG00KM4WR7)
dimethicone (UNII: 92RU3N3Y1O)
silicon dioxide (UNII: ETJ7Z6XBU4)
picea abies wood (UNII: 72GZ8K8996)
sodium ascorbyl phosphate (UNII: 836SJG51DR)
vitamin a palmitate (UNII: 1D1K0N0VVC)
tocopherol (UNII: R0ZB2556P8)
.alpha.-tocopherol acetate, DL- (UNII: WR1WPI7EW8)
titanium dioxide (UNII: 15FIX9V2JP)
aloe vera leaf (UNII: ZY81Z83H0X)
bentonite (UNII: A3N5ZCN45C)
carbomer copolymer type A (UNII: 71DD5V995L)
sodium polyacrylate (8000 mw) (UNII: 285CYO341L)
kaolin (UNII: 24H4NWX5CO)
ethylhexylglycerin (UNII: 147D247K3P)
edetate disodium (UNII: 7FLD91C86K)
sodium hydroxide (UNII: 55X04QC32I)
chlorphenesin (UNII: I670DAL4SZ)
phenoxyethanol (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68634-053-01	1 in 1 CARTON
1		90 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/01/2016

Labeler - AMCOL Health & Beauty Solutions, Inc. DBA (872684803)

Establishment
Name	Address	ID/FEI	Business Operations
AMCOL Health & Beauty Solutions, Inc. DBA		872684803	MANUFACTURE(68634-053) , ANALYSIS(68634-053)