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 CVS Health, AMCOL Health & Beauty Solutions, Inc. DBA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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: 69842-021
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	homosalate	100 mg  in 1 mL
oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	oxybenzone	60 mg  in 1 mL
octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	octisalate	50 mg  in 1 mL
avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	avobenzone	30 mg  in 1 mL
octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	octocrylene	20 mg  in 1 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: 69842-021-01	1 in 1 CARTON	04/01/2016
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 - CVS Health (062312574)

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

Establishment
Name	Address	ID/FEI	Business Operations
AMCOL Health & Beauty Solutions, Inc. DBA		872684803	ANALYSIS(69842-021) , MANUFACTURE(69842-021) , LABEL(69842-021) , PACK(69842-021)