FDA.reportPublic FDA data

MICRO RETOUCHING

Manufacturer
THEFACESHOP CO., LTD. | THEFACESHOP NORTH AMERICA, INC. | Kolmar Korea Co., Ltd.
Effective date
2015-09-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:43:44

Label at a glance#

ProductMICRO RETOUCHING N203 NATURAL BEIGE SPF50
Active ingredientOCTINOXATE
Label structure10 sections

Indications and uses

Helps prevent sunburn.

Dosage and administration

Apply generously and evenly 15 minutes before sun exposure. Children under 6 months of age: Ask a doctor. Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging. Reapply at least every 2 hours. Use a water-resistant sunscreen if swimming or sweating. Apply an adequa...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 3.0 %

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses:

OTC - PURPOSE SECTION

Helps prevent sunburn.

Warnings:

WARNINGS SECTION

For external use only.

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs.

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

OTC - WHEN USING SECTION

Apply generously and evenly 15 minutes before sun exposure.
Children under 6 months of age: Ask a doctor.
Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
Reapply at least every 2 hours.
Use a water-resistant sunscreen if swimming or sweating.

Apply an adequate amount on face in a light patting motion by using puff.

OTHER SAFETY INFORMATION

Protect the product in this container from excessive heat and direct sun.

May stain or damage some fabrics or surfaces.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

TALC, MICA, SILICA, TITANIUM DIOXIDE, SYNTHETIC FLUORPHLOGOPITE, ISOTRIDECYL ISONONANOATE, NYLON-12, BARIUM SULFATE, ZINC OXIDE, ACRYLATES/STEARYL ACRYLATE/DIMETHICONE METHACRYLATE COPOLYMER, TRIETHOXYCAPRYLYLSILANE, BIS-ETHYLHEXYLOXYPHENOL ETHOXYPHENYL TRIAZINE, DIISOSTEARYL MALATE, METHICONE, 1,2-HEXANEDIOL, GLYCERYL CAPRYLATE, HYDROGENATED LECITHIN, AMINOPROPYL DIMETHICONE, POLYMETHYLSILSESQUIOXANE, C9-15 FLUOROALCOHOL PHOSPHATE, ACRYLATES/TRIDECYL ACRYLATE/TRIETHOXYSILYLPROPYL METHACRYLATE/DIMETHICONE METHACRYLATE COPOLYMER, MAGNESIUM MYRISTATE, HYDROXYAPATITE, RUBUS CHAMAEMORUS SEED EXTRACT, VOLCANIC ASH, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER WATER, WATER, BUTYLENE GLYCOL, DIMETHICONE, CHENOPODIUM QUINOA SEED EXTRACT, FRAGRANCE, IRON OXIDES(CI 77492, CI77491 and CI 77499)

OTC - QUESTIONS SECTION

Questions or comments? Call 1-866-638-8417

Distributed by:

SPL UNCLASSIFIED SECTION

THEFACESHOP NORTH AMERICA, INC.

Santa Fe Springs, CA 90670

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MICRO RETOUCHING

BLUR COMPACT SUNSCREEN POWDER

V203 NATURAL BEIGE SPF50+ PA+++

Blur compact powder keeps skin looking bright and smooth even after touch-ups.

Makes skin look smooth and bright for a flawless finish.

Contains Perfect Seed to keep skin clean and fresh by taking care of dead cells and sebum.

LabelLabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51523-377-292022-01-28C16284748780-1d6a99b39-6826-a426-e053-dadaa90af4c2MICRO RETOUCHING BLUR COMPACT SUNSCREEN POWDER N203 NATURAL BEIGE SPF 50+ PA+++ 34200377

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51523-377-29MICRO RETOUCHINGN203 NATURAL BEIGE SPF501 in 1 CARTONPOWDER11
51523-377-29MICRO RETOUCHINGN203 NATURAL BEIGE SPF5014 g in 1 CONTAINERPOWDER141

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51523-377MICRO RETOUCHING N203 NATURAL BEIGE SPF50 (OCTINOXATE POWDER) POWDER [THEFACESHOP CO., LTD.]1Legacy NDC, 2 package rows20151001_20d0120d-e21a-25fd-e054-00144ff8d46c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD511
OCTINOXATEACTIVE MOIETY4Y5P7MUD511
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51523-37751523-377-29

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTINOXATE4Y5P7MUD51ACTIB
WATER059QF0KO0RIACT

Source Document#

Source XML

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
20d0120d-e21b-25fd-e054-00144ff8d46c20d0120d-e21a-25fd-e054-00144ff8d46c2015-09-28WarningsExact identifier
spl id: 20d0120d-e21b-25fd-e054-00144ff8d46c
spl set id: 20d0120d-e21a-25fd-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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