SKIN PHARMACY ADVANCED SUN THERAPY BROAD SPECTRUM SPF 30 SUN- homosalate, octisalate, avobenzone, oxybenzone, octocrylene liquid

Skin Pharmacy Advanced Sun Therapy Broad Spectrum SPF 30 Sun by

Drug Labeling and Warnings

Skin Pharmacy Advanced Sun Therapy Broad Spectrum SPF 30 Sun 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 4.0%

Octisalate 4.0%

Octocrylene 2.0%

Oxybenzone 3.0%

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, C12-15 Alkyl Benzoate, Butylene Glycol, VP/Eicosene Copolymer, Sodium Cetearyl Sulfate, Methyl Glucose Sesquistearate, Glyceryl Stearate, Cetearyl Alcohol, Dimethicone, Picea Albies Wood Extract, Aloe Barbadensis (Aloe Vera) Leaf Juice, Tocopheryl Acetate, Retinyl Palmitate, Sodium Ascorbyl Phosphate, Tocopherol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Bentonite, Sodium Polyacrylamide, Disodium EDTA, Titanium Dioxide, Sodium Hydroxide, Phenoxyethanol, Chlorphenesin, Ethylhexylglycerin.

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
M050899CP FP100

________________________________________________________

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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 30 SUN LOTION

UVA/UVB protection with Polargel® UV Technology

Sunscreen with antioxidant Vitamins A, C & E for protection against free radicals

Polargel® UV Technology allows lower sunscreen actives & optimizes performance

with Aloe Vera to help keep skin moisturized

water resistant (80 minutes)

paraben, oil & fragrance free

DERMATOLOGIST TESTED

exclusively at CVS/pharmacy

Actual Product Size on Side Panel

6 FL OZ (180 mL)

Principal Display Panel - Tube Label

SKIN-PHARMACY® ADVANCED SUN THERAPY

BROAD SPECTRUM SPF 30 SUN LOTION

UVA/UVB protection with Polargel® UV Technology

Sunscreen with antioxidant Vitamins A, C & E for protection against free radicals

Polargel® UV Technology allows lower sunscreen actives & optimizes performance

with Aloe Vera to help keep skin moisturized

water resistant (80 minutes)

paraben, oil & fragrance free

DERMATOLOGIST TESTED

exclusively at CVS/pharmacy

6 FL OZ (180 mL)

INGREDIENTS AND APPEARANCE

SKIN PHARMACY ADVANCED SUN THERAPY BROAD SPECTRUM SPF 30 SUN 
homosalate, octisalate, avobenzone, oxybenzone, octocrylene liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68634-052
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	40 g  in 2 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	40 g  in 2 mL
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	30 g  in 2 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	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)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DIMETHICONE (UNII: 92RU3N3Y1O)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
BENTONITE (UNII: A3N5ZCN45C)
CHLORPHENESIN (UNII: I670DAL4SZ)
PICEA ABIES WOOD (UNII: 72GZ8K8996)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68634-052-01	1 in 1 CARTON
1		180 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(68634-052) , ANALYSIS(68634-052)