FDA.reportPublic FDA data

MISSHA M Perfect Cover BB Cream SPF42 (No. 25)

Manufacturer
Able C&C Co., Ltd. | HANACOS CO., LTD.
Effective date
2024-12-05
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:40:33

Label at a glance#

ProductMISSHA M Perfect Cover BB Cream SPF42 (No. 25)
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE, OCTINOXATE
Label structure10 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 aging. To decrease this risk, regulary use a sunscreen with SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. - 2 ...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7.5%, Active Ingredients: Zinc Oxide 7.0%, Titanium Dioxide 4.20%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE 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

Directions

DOSAGE & ADMINISTRATION 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 aging. To decrease this risk, regulary use a sunscreen with SPF value 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-sleeved shirts, pants, hats and sunglasses

Other Information

OTHER SAFETY INFORMATION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Cyclomethicone, Propylene Glycol, Caprylic/Capric Triglyceride, PEG-10 Dimethicone, Iron Oxides (CI 77492), Cetyl PEG/PPG-10/1 Dimethicone, Arbutin, Mineral Oil, Glycerin, Polyethylene, Talc, Beeswax (Cera Alba), Phenyl Trimethicone, Sodium Chloride, Iron Oxides (CI 77491 ), Methylparaben, Iron Oxides (CI 77499), Dimethicone, Propylparaben, Rosa Canina Fruit Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Squalane, Macadamia Ternifolia Seed Oil, Hydrolyzed Collagen, Disodium EDTA, Adenosine, Algae Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Fagus Sylvatica Bud Extract, Sodium Hyaluronate, Ceramide 3, Chamomilla Recutita (Matricaria) Flower Extract, Fragrance (Parfum), Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde, Butylphenyl Methylpropional, Benzyl Salicylate, Hydroxycitronellal, Alpha-Isomethyl Ionone, Hexyl Cinnamal, Linalool, Citronellol

Questions or Comments?

OTC - QUESTIONS SECTION

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

WARNINGS SECTION

Warnings:
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 ocurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton ImageCarton Image

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
d676a241-be05-4740-b3ee-1a5f2ed422d2Product name420180615
dd8bd48f-20d6-43c7-b471-3ae872868afaProduct name320180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d41954ff-bc63-4b2c-aba0-9146707659d7Product name220151117
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13733-165-01MISSHA M Perfect Cover BB Cream SPF42 (No. 25)50 mL in 1 CARTONCREAM504
13733-165-02MISSHA M Perfect Cover BB Cream SPF42 (No. 25)1 mL in 1 PACKETCREAM14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13733-165MISSHA M PERFECT COVER BB CREAM SPF42 (NO. 25) (ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE) CREAM [ABLE C&C CO., LTD.]4Current NDC, Legacy NDC, 2 package rows20241207_604e7a49-7986-11ee-e053-2a91aa0a1bee.zip

Products#

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

DailyMed product names page 1 of 2 · 48 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
13733-16513733-165-01, 13733-165-02

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 45 matching rows.

Name, UNII, Kind table
NameUNIIKind
PHENOXYETHANOLHIE492ZZ3TIACT
TROPOLONE7L6DL16P1TIACT
SODIUM CHLORIDE451W47IQ8XIACT
MACADAMIA OIL515610SU8CIACT
HYALURONATE SODIUMYSE9PPT4THIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
TALC7SEV7J4R1UIACT
WATER059QF0KO0RIACT
CYCLOMETHICONENMQ347994ZIACT
HIGH DENSITY POLYETHYLENEUG00KM4WR7IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)V2W71V8T0XIACT
ARBUTINC5INA23HXFIACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
MINERAL OILT5L8T28FGPIACT
TRIS(TRIMETHYLSILOXY)PHENYLSILANES3QI0ZXT5XIACT
ABRONIA VILLOSA LEAFA138B5260AIACT
PROPYLPARABENZ8IX2SC1OHIACT
JOJOBA OIL724GKU717MIACT
TOCOPHEROLR0ZB2556P8IACT
YELLOW WAX2ZA36H0S2VIACT
CYCLOMETHICONE 4CZ227117JEIACT
LAMINARIA HYPERBOREANXA595GQ1KIACT
CHAMOMILE FLOWER OIL60F80Z61A9IACT
CERAMIDE APF1X8L2B00JIACT
FERRIC OXIDE RED1K09F3G675IACT
METHYLPARABENA2I8C7HI9TIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
DIMETHICONE92RU3N3Y1OIACT
SQUALANEGW89575KF9IACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
ADENOSINEK72T3FS567IACT
ROSEMARYIJ67X351P9IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
FAGUS SYLVATICA FLOWER BUD6D5V13045WIACT
CAPRYLYL GLYCOL00YIU5438UIACT
BENZYL ALCOHOLLKG8494WBHIACT
1,2-HEXANEDIOLTR046Y3K1GIACT

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
MISSHA M Perfect Cover BB Cream SPF42 (No. 25)ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATEAble C&C Co., Ltd.604e7a49-7986-11ee-e053-2a91aa0a1bee2024-12-05WarningsExact identifier
ndc (package): 13733-165-02
ndc (package): 13733-165-01
ndc (product): 13733-165
ndc11 (package): 13733016501
ndc11 (package): 13733016502
spl id: 28828529-f980-2e24-e063-6394a90adb5b
spl set id: 604e7a49-7986-11ee-e053-2a91aa0a1bee

Reported adverse events (FAERS/openFDA)#

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