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NDC 69842-0021-01 SkinPharmacy Advanced Sun Therapy Broad Spectrum SPF 50 Face 30; 100; 50; 20; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL Details

SkinPharmacy Advanced Sun Therapy Broad Spectrum SPF 50 Face 30; 100; 50; 20; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL

SkinPharmacy Advanced Sun Therapy Broad Spectrum SPF 50 Face is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by CVS Health. The primary component is AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE.

Product Information

NDC	69842-0021
Product ID	69842-021_869054ce-7c49-458f-95b0-7a042ed0adbb
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	SkinPharmacy Advanced Sun Therapy Broad Spectrum SPF 50 Face
Proprietary Name Suffix	n/a
Non-Proprietary Name	homosalate, oxybenzone, octisalate, avobenzone, octocrylene
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	30; 100; 50; 20; 60
Active Ingredient Units	mg/mL; mg/mL; mg/mL; mg/mL; mg/mL
Substance Name	AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
Labeler Name	CVS Health
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part352
Listing Certified Through	2024-12-31

Package

Package Images

NDC 69842-0021-01 (69842002101)

Pricing Information	N/A
NDC Package Code	69842-021-01
Billing NDC	69842002101
Package	1 TUBE in 1 CARTON (69842-021-01) / 90 mL in 1 TUBE
Marketing Start Date	2016-04-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL efbdfe0e-c602-48f6-9faf-dc85298f1741 Details

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.

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	04/01/2016

Labeler - CVS Health (062312574)

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

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

Revised: 3/2017

Document Id: 869054ce-7c49-458f-95b0-7a042ed0adbb

Set id: efbdfe0e-c602-48f6-9faf-dc85298f1741

Version: 1

Effective Time: 20170307