FDA.reportPublic FDA data

Limited Line Edition 2018 MISSHA M Perfect Cover BB Cream

Manufacturer
Able C&C Co., Ltd. | HANACOS CO., LTD.
Effective date
2019-10-22
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:01:17

Label at a glance#

ProductLimited Line Edition 2018 MISSHA M Perfect Cover BB No 23
Active ingredientOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE
Label structure11 sections

Indications and 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 caused by the sun

Dosage and administration

apply liberally 15 minutes before sun exposure reapply at least every 2 hours use a water-resistant sunscreen if swimming or sweating Sun Protection Measures . Spending time in the sun increases your risk of skin cancer and early skin againg. To decrease this risk, regularly use a sunscreen with SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10a.m.-2p....

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7.5%

Zinc Oxide 7%

Titanium Dioxide 4.19%

PURPOSE

OTC - PURPOSE SECTION

Sunscreen

Uses

INSTRUCTIONS FOR USE SECTION

  • helps prevent sunburn
  • if used as directed with other sun protection measures(see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to Remove.

Directions

DESCRIPTION SECTION

  • apply liberally 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a water-resistant sunscreen if swimming or sweating

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

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

Other Information

OTHER SAFETY INFORMATION

protect the product in this container from excessive heat and direct sun

Inactive Ingredient

INACTIVE INGREDIENT SECTION

WATER, CYCLOMETHICONE, CAPRYLIC/CAPRIC TRIGLYCERIDE, ARBUTIN, MINERAL OIL, TALC, PHENYL TRIMETHICONE, METHYLPARABEN, DIMETHICONE, PROPYLPARABEN, ROSA RUBIGINOSA SEED OIL, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL, SQUALANE, MACADAMIA TERNIFOLIA SEED OIL

Questions of comments?

INFORMATION FOR OWNERS/CAREGIVERS SECTION

Visit www.misshaus.com or call 1-888-985-9887(Ext 104)

[Limited Line Edition 2018] MISSHA M Perfect Cover BB No 21

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LineEditionMisshaBB21LineEditionMisshaBB21

[Limited Line Edition 2018] MISSHA M Perfect Cover BB No 23

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LineEditionMisshaBB23LineEditionMisshaBB23

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d676a241-be05-4740-b3ee-1a5f2ed422d2Product name420180615
dd8bd48f-20d6-43c7-b471-3ae872868afaProduct name320180125
d41954ff-bc63-4b2c-aba0-9146707659d7Product name220151117

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
13733-411-012022-01-28C16284748780-1d6a99b39-b96f-a426-e053-dadaa90af4c2Limited Line Edition 2018 MISSHA M Perfect Cover BB Cream
13733-412-012022-01-28C16284748780-1d6a99b39-b96f-a426-e053-dadaa90af4c2Limited Line Edition 2018 MISSHA M Perfect Cover BB Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13733-411-01Limited Line Edition 2018 MISSHA M Perfect Cover BB No 2320 g in 1 TUBECREAM202
13733-412-01Limited Line Edition 2018 MISSHA M Perfect Cover BB No 2150 g in 1 TUBECREAM502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13733-411LIMITED LINE EDITION 2018 MISSHA M PERFECT COVER BB NO 23 (OCTINOXATE, ZINC OXIDE, TITANIUM DIOXIDE) CREAM LIMITED LINE EDITION 2018 MISSHA M PERFECT COVER BB NO 21 (OCTINOXATE, ZINC OXIDE, TITANIUM DIOXIDE) CREAM [ABLE C&C CO., LTD.]2Legacy NDC, 1 package rows20191023_839e929a-c38e-728e-e053-2a91aa0a61e4.zip
13733-412LIMITED LINE EDITION 2018 MISSHA M PERFECT COVER BB NO 23 (OCTINOXATE, ZINC OXIDE, TITANIUM DIOXIDE) CREAM LIMITED LINE EDITION 2018 MISSHA M PERFECT COVER BB NO 21 (OCTINOXATE, ZINC OXIDE, TITANIUM DIOXIDE) CREAM [ABLE C&C CO., LTD.]2Legacy NDC, 1 package rows20191023_839e929a-c38e-728e-e053-2a91aa0a61e4.zip

Products#

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

DailyMed product names page 1 of 1 · 37 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
13733-41213733-412-01
13733-41113733-411-01

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 68 matching rows.

Name, UNII, Kind table
NameUNIIKind
JOJOBA OIL724GKU717MIACT
CYCLOMETHICONENMQ347994ZIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
HYALURONATE SODIUMYSE9PPT4THIACT
WHITE WAX7G1J5DA97FIACT
HIGH DENSITY POLYETHYLENEUG00KM4WR7IACT
GLYCERINPDC6A3C0OXIACT
FERRIC OXIDE RED1K09F3G675IACT
ARBUTINC5INA23HXFIACT
WATER059QF0KO0RIACT
MINERAL OILT5L8T28FGPIACT
TRIS(TRIMETHYLSILOXY)PHENYLSILANES3QI0ZXT5XIACT
METHYLPARABENA2I8C7HI9TIACT
SQUALANEGW89575KF9IACT
MACADAMIA OIL515610SU8CIACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)V2W71V8T0XIACT
PEG/PPG-18/18 DIMETHICONE9H0AO7T794IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM CHLORIDE451W47IQ8XIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
DIMETHICONE92RU3N3Y1OIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
ADENOSINEK72T3FS567IACT
CAVIAR, UNSPECIFIED020K6HLU0OIACT
ROSEMARYIJ67X351P9IACT
FAGUS SYLVATICA FLOWER BUD6D5V13045WIACT
CERAMIDE 6 IIF1X8L2B00JIACT
TALC7SEV7J4R1UIACT
PROPYLPARABENZ8IX2SC1OHIACT
ROSA RUBIGINOSA SEED OIL8M1P49MWAPIACT
OCTINOXATE4Y5P7MUD51ACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIB
JOJOBA OIL724GKU717MIACT
CYCLOMETHICONENMQ347994ZIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
HYALURONATE SODIUMYSE9PPT4THIACT
WHITE WAX7G1J5DA97FIACT
HIGH DENSITY POLYETHYLENEUG00KM4WR7IACT

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
95814d3d-0659-4bbb-e053-2a95a90aef71839e929a-c38e-728e-e053-2a91aa0a61e42019-10-22Exact identifier
spl id: 95814d3d-0659-4bbb-e053-2a95a90aef71
spl set id: 839e929a-c38e-728e-e053-2a91aa0a61e4

Reported adverse events (FAERS/openFDA)#

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