POWERPATCH DARK SPOT PROTECTOR- avobenzone, homosalate, octisalate, octocrylene, oxbenzone gel

PowerPatch Dark Spot Protector by

Drug Labeling and Warnings

PowerPatch Dark Spot Protector by is a Otc medication manufactured, distributed, or labeled by Raining Rose. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DARK SPOT PROTECTIOR SUNSCREEN GELBROAD SPECTRUM SPF 30:Drug FactsActive ingredient(s)

Avobenzone 3%

Homosalate 8%

Octisalate 5%

Octocrylene 2.8%

Oxybenzone 3%

Purpose

Sunscreen

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.

Uses

• helps prevent sunburn

Warnings

For external use only

Do not use

on damaged or broken skin

When using this product

keep out of the eyes. Rinse with water to remove.

Stop use and ask a doctor

if rash occurs

Directions

For sunscreen use

• apply liberally 15 minutes before sun exposure
• use a water resistant sunscreen if swimming or sweating
• reapply at least every 2 hours
• children under 6 months ask a doctor

Sun protection measures

Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF of 15 or higher and other sun protection measures including:

• limit time in the sun, especially from 10 a.m. - 2 p.m.
• wear long-sleeve shirts, pants, hats, and sunglasses

Inactive ingredients

Alcohol, Algae Extract, BHT, Butylene Glycol, Butyloctyl Salicylate, Hydrogenated Glyceryl Abietate, Isododecane & Dimethicone/Bis-isobutyl PPG-copolymer, Isoarryl Cocoate, Isoamyl Laurate, Kiwi fruit Water, Lemon Oil, Licorice Root Extract, Menthone Glycerin Acetyl, Pomegranate Oil, Sophora Flavescens Root Extract, Tumeric Extract

Other information

Protect this product from excessive heat and direct sun

Questions or comments?

Call toll free 1-888-243-0646

Dark Spot Corrector product label

patchology®

POWERPATCH™

DARK SPOT PROTECTOR
SUNSCREEN GEL
BROAD SPECTRUM SPF 30

20 mL

DARK SPOT PROTECTOR SUNSCREEN GEL

BROAD SPECTRUM SPF 30

Shades spots from skin-damaging rays during the day.

For use withPowerPatch Dark Spot Corrector Patches.

DIRECTIONS

Apply a thin layer of gel over treatment area only. Use every morning after cleansing.

IF IRRITATION OCCURS, STOP USE AND RINSE THOROUGHLY WITH WATER.

DIST. BY/PAR IONTERA, INC.,

DEDHAM, MA 02026
ALL RIGHTS RESERVED
MADE IN THE USA

QUESTIONS?
1-888-243-0646
PATCHOLOGY.COM

INGREDIENTS AND APPEARANCE

POWERPATCH DARK SPOT PROTECTOR 
avobenzone, homosalate, octisalate, octocrylene, oxbenzone gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65692-0588
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.6 g  in 20 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	1.6 g  in 20 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	1.0 g  in 20 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.56 g  in 20 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.6 g  in 20 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
LAMINARIA ANGUSTATA (UNII: 2J2UIK8XBZ)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
GLYCERYL ABIETATE (UNII: 2F22LY70Q1)
ISODODECANE (UNII: A8289P68Y2)
DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER (UNII: O4I3UFO6ZF)
ISOAMYL COCOATE (UNII: 14OG46E98E)
ISOAMYL LAURATE (UNII: M1SLX00M3M)
KIWI FRUIT (UNII: 71ES77LGJC)
LEMON OIL (UNII: I9GRO824LL)
LICORICE (UNII: 61ZBX54883)
MENTHONE 1,2-GLYCEROL KETAL, (+/-)- (UNII: 7QQ1EE6RCP)
POMEGRANATE SEED OIL (UNII: 0UI45XV0T6)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
TURMERIC (UNII: 856YO1Z64F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65692-0588-1	20 mL in 1 TUBE; Type 0: Not a Combination Product	09/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	09/01/2016

Labeler - Raining Rose (083819404)

Registrant - Raining Rose (083819404)

Establishment
Name	Address	ID/FEI	Business Operations
Raining Rose		083819404	manufacture(65692-0588)