MISSHA M PRISM BRIGHT ON AUTO

Manufacturer
ABLE C&C CO., LTD.
Effective date
2012-10-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:33:24

Label at a glance#

ProductMISSHA M PRISM BRIGHT ON AUTO NO.2 SPF35 PA PLUS PLUS PLUS
Active ingredientTitanium Dioxide, OCTINOXATE, Zinc Oxide
Label structure8 sections

Indications and uses

INDICATION AND USAGE: Step 1. Take an appropriate amount of powder onto vibrating puff and dab it on forehead, cheek and chin. Step 2. Turn on the vibrating puff and spread the powder evenly on face. Step 3. Turn off the vibrating puff to stop. - How to replace the puff Step 1. Hold the body of vibrating puff and slowly pull out the end to separate. Step 2. Place the new puff in the casing. Step 3. Press down on t...

Dosage and administration

DOSAGE AND ADMINISTRATION: Take appropriate amount according to your skin condition and apply as you desire. Remove it before sleeping.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS: Titanium Dioxide 8.54%, Ethylhexyl Methoxycinnamate 6%, Zinc Oxide 2.94%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS:
Talc, Mica, Nylon-12, Silica, Methyl Methacrylate Crosspolymer, Magnesium Myristate, Diisostearyl Malate, Phenyl Trimethicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Synthetic Beeswax, Pearl Powder, Plukenetia Volubilis Seed Oil, Lilium Candidum Flower Extract, Iris Versicolor Extract, Leontopodium Alpinum Flower/Leaf Extract, Nelumbo Nucifera Flower Extract, Rose Extract, Jasminum Officinale (Jasmine) Flower/Leaf Extract, Freesia Refracta Extract, Narcissus Pseudo-Narcissus (Daffodil) Flower Extract, Triethylhexanoin, Magnesium Stearate, Triethoxycaprylylsilane, Dimethicone, Methicone, Ethylhexylglycerin, Glyceryl Caprylate, Stearic Acid, Myristoyl/Palmitoyl Oxostearamide/Arachamide MEA, Diphenyl Dimethicone/Vinyl Diphenyl Dimethicone/Silsesquioxane Crosspolymer, Phytosterols, Sodium Hyaluronate, Water, Butylene Glycol, Cetearyl Alcohol, Fragrance(Parfum), Iron Oxides

PURPOSE

OTC - PURPOSE SECTION

PURPOSE: This combination of Cosmetic / OTC Drug can be used as a sunscreen and as a cosmetic to cover your blemishes / scar and to tone up your skin care.

WARNINGS

WARNINGS SECTION

WARNING:
For external use only.
Do not swallow.
Keep out of reach of children.
Avoid contact with eyes.
Do not use on exposed wounds or if you are allergic to any ingredients of this product.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

INDICATION AND USAGE:
Step 1. Take an appropriate amount of powder onto vibrating puff and dab it on forehead, cheek and chin.
Step 2. Turn on the vibrating puff and spread the powder evenly on face.
Step 3. Turn off the vibrating puff to stop.

- How to replace the puff
Step 1. Hold the body of vibrating puff and slowly pull out the end to separate.
Step 2. Place the new puff in the casing.
Step 3. Press down on the puff to fix and arrange the edges.

- How to replace the battery
Step 1. Hold the body of vibrating puff and slowly pull out the end to separate.
Step 2. Twist the body of vibrating puff to separate. (Do not twist the vibrator inside to avoid damage)
Step 3. Replace Lithium battery.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

DOSAGE AND ADMINISTRATION:
Take appropriate amount according to your skin condition and apply as you desire.
Remove it before sleeping.

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
13733-017-012019-11-27C16284748780-19855d018-d7a5-cd31-e053-dbdaa90ab51a1bcd928e-b137-4551-b53f-ac0bb798f427

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13733-017-01MISSHA M PRISM BRIGHT ON AUTONO.2 SPF35 PA PLUS PLUS PLUS9.5 g in 1 CARTONPOWDER9.51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13733-017MISSHA M PRISM BRIGHT ON AUTO NO.2 SPF35 PA PLUS PLUS PLUS (TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE) POWDER [ABLE C&C CO., LTD.]1Legacy NDC, 1 package rows20121029_1bcd928e-b137-4551-b53f-ac0bb798f427.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD511
Titanium DioxideACTIVE INGREDIENT15FIX9V2JP1
Zinc OxideACTIVE INGREDIENTSOI2LOH54Z1
OCTINOXATEACTIVE MOIETY4Y5P7MUD511
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JP1
ZINC OXIDEACTIVE MOIETYSOI2LOH54Z1
DimethiconeINACTIVE INGREDIENT92RU3N3Y1O1
Magnesium MyristateINACTIVE INGREDIENTZ1917F05781
MicaINACTIVE INGREDIENTV8A1AW08801
TalcINACTIVE INGREDIENT7SEV7J4R1U1

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
13733-01713733-017-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 35 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
TalcTALC7SEV7J4R1UTABLET / RECTAL32.4 mgExact identifier — unii candidate
35 equally ranked IID candidates
TalcTALC7SEV7J4R1UELIXIR / ORAL4.5 mg/5mlExact identifier — unii candidate
35 equally ranked IID candidates
TalcTALC7SEV7J4R1USUSPENSION / ORAL234 mgExact identifier — unii candidate
35 equally ranked IID candidates
TalcTALC7SEV7J4R1UTABLET / ORAL1000 mgExact identifier — unii candidate
35 equally ranked IID candidates
TalcTALC7SEV7J4R1UGRANULE, DELAYED RELEASE / ORAL525 mgExact identifier — unii candidate
35 equally ranked IID candidates
TalcTALC7SEV7J4R1UTABLET, DELAYED RELEASE / ORAL349 mgExact identifier — unii candidate
35 equally ranked IID candidates
TalcTALC7SEV7J4R1UCAPSULE, EXTENDED RELEASE / ORAL5119 mgExact identifier — unii candidate
35 equally ranked IID candidates
TalcTALC7SEV7J4R1ULOZENGE / ORAL50 mgExact identifier — unii candidate
35 equally ranked IID candidates
TalcTALC7SEV7J4R1UOINTMENT / TOPICAL74.6 %w/wExact identifier — unii candidate
35 equally ranked IID candidates
TalcTALC7SEV7J4R1UTABLET, FILM COATED / ORAL91 mgExact identifier — unii candidate
35 equally ranked IID candidates
TalcTALC7SEV7J4R1UTABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
35 equally ranked IID candidates
TalcTALC7SEV7J4R1UDROPS / ORALNAExact identifier — unii candidate
35 equally ranked IID candidates
TalcTALC7SEV7J4R1UCAPSULE, COATED / ORAL87 mgExact identifier — unii candidate
35 equally ranked IID candidates
TalcTALC7SEV7J4R1UPOWDER / TOPICAL9235 mgExact identifier — unii candidate
35 equally ranked IID candidates
TalcTALC7SEV7J4R1UTABLET / BUCCAL15 mgExact identifier — unii candidate
35 equally ranked IID candidates
TalcTALC7SEV7J4R1UCAPSULE / ORAL729 mgExact identifier — unii candidate
35 equally ranked IID candidates
TalcTALC7SEV7J4R1UTABLET, ORALLY DISINTEGRATING / ORAL80 mgExact identifier — unii candidate
35 equally ranked IID candidates
TalcTALC7SEV7J4R1UPOWDER, FOR SUSPENSION / ORAL735 mgExact identifier — unii candidate
35 equally ranked IID candidates
TalcTALC7SEV7J4R1UCAPSULE, DELAYED RELEASE / ORAL420 mgExact identifier — unii candidate
35 equally ranked IID candidates
TalcTALC7SEV7J4R1UTABLET / SUBLINGUAL32.4 mgExact identifier — unii candidate
35 equally ranked IID candidates
TalcTALC7SEV7J4R1USUSPENSION, EXTENDED RELEASE / ORAL46 mgExact identifier — unii candidate
35 equally ranked IID candidates
TalcTALC7SEV7J4R1UTABLET, COATED / ORAL320.75 mgExact identifier — unii candidate
35 equally ranked IID candidates
TalcTALC7SEV7J4R1UTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL357 mgExact identifier — unii candidate
35 equally ranked IID candidates
TalcTALC7SEV7J4R1UGRANULE, FOR SUSPENSION / ORAL296 mgExact identifier — unii candidate
35 equally ranked IID candidates
TalcTALC7SEV7J4R1UCAPSULE, COATED, EXTENDED RELEASE / ORAL20 mgExact identifier — unii candidate
35 equally ranked IID candidates
TalcTALC7SEV7J4R1UTABLET, DELAYED RELEASE PARTICLES / ORAL56 mgExact identifier — unii candidate
35 equally ranked IID candidates
TalcTALC7SEV7J4R1UTABLET, FILM COATED, EXTENDED RELEASE / ORAL60 mgExact identifier — unii candidate
35 equally ranked IID candidates
TalcTALC7SEV7J4R1UCAPSULE, COATED PELLETS / ORAL14 mgExact identifier — unii candidate
35 equally ranked IID candidates
TalcTALC7SEV7J4R1UTABLET, CHEWABLE, EXTENDED RELEASE / ORAL18 mgExact identifier — unii candidate
35 equally ranked IID candidates
TalcTALC7SEV7J4R1UTABLET, FOR SUSPENSION / ORAL24 mgExact identifier — unii candidate
35 equally ranked IID candidates
TalcTALC7SEV7J4R1UGRANULE / ORAL322 mgExact identifier — unii candidate
35 equally ranked IID candidates
TalcTALC7SEV7J4R1UPELLET / ORAL69 mgExact identifier — unii candidate
35 equally ranked IID candidates
TalcTALC7SEV7J4R1UTABLET, CHEWABLE / ORAL202 mgExact identifier — unii candidate
35 equally ranked IID candidates
TalcTALC7SEV7J4R1UGUM, CHEWING / BUCCALNAExact identifier — unii candidate
35 equally ranked IID candidates
TalcTALC7SEV7J4R1UTABLET, EXTENDED RELEASE / ORAL300 mgExact identifier — unii candidate
35 equally ranked IID candidates

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
7d4f3728-9ac2-4b6c-9d24-5f22bb430dc91bcd928e-b137-4551-b53f-ac0bb798f4272012-10-29WarningsExact identifier
spl id: 7d4f3728-9ac2-4b6c-9d24-5f22bb430dc9
spl set id: 1bcd928e-b137-4551-b53f-ac0bb798f427

Reported adverse events (FAERS/openFDA)#

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