PowerPatch Dark Spot Protector

Manufacturer
Raining Rose
Effective date
2016-07-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:47:00

Label at a glance#

ProductPowerPatch Dark Spot Protector
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE
Label structure13 sections

Indications and uses

helps prevent sunburn

Dosage and administration

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 measur...

Label contents#

Full prescribing information#

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

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%

Homosalate 8%

Octisalate 5%

Octocrylene 2.8%

Oxybenzone 3%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

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

Stop use and ask a doctor

OTC - STOP USE SECTION

if rash occurs

Directions

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-888-243-0646

Dark Spot Corrector product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

RR PPP Dark SpotRR PPP Dark Spot

RR PPP Dark Spot 2RR PPP Dark Spot 2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65692-0588-12021-01-29C16284748780-1ba0f9c33-3675-a910-e053-dadaa90a0b85RR Dark Spot Corrector - 0588

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65692-0588-1PowerPatch Dark Spot Protector20 mL in 1 TUBEGEL201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65692-0588POWERPATCH DARK SPOT PROTECTOR (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXBENZONE) GEL [RAINING ROSE]1Legacy NDC, 1 package rows20160901_3283c64b-ad5a-48f7-8f92-d43aa16eb17b.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65692-058865692-0588-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f234a643-d321-42ce-9e8c-54e13870d2b23283c64b-ad5a-48f7-8f92-d43aa16eb17b2016-07-22WarningsExact identifier
spl id: f234a643-d321-42ce-9e8c-54e13870d2b2
spl set id: 3283c64b-ad5a-48f7-8f92-d43aa16eb17b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.