FDA.reportPublic FDA data

PEDATOSOL OATTBE SYN BIO BETA GLUCANS DERMA BLEMISH BALM

Manufacturer
Mh Global Co., Ltd. | Aju cosmetic Co., Ltd.
Effective date
2021-01-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:36:38

Label at a glance#

ProductPEDATOSOL OATTBE SYN BIO BETA GLUCANS DERMA BLEMISH BALM
Active ingredientTitanium Dioxide, OCTINOXATE
Label structure9 sections

Indications and uses

BB CREAM : Offering natural-looking coverage with a flawless finish, our top-rated tinted moisturizer BB (Blemish Balm) cream can use this gentle tinted moisturizer for sensitive skin as well as normal, combination, oily, acne-prone or dry skin. Made with Hydro colloidal oat, this daily facial Blemish Balm provides UVA and UVB sun protection to help prevent sunburns and signs of premature skin aging

Dosage and administration

BB Cream protects skin with SPF 15 so you can wear a moisturizer and sunscreen in one convenient beauty product. ■ Apply on all exposed areas 15-20 minutes before sun exposure. ■ Re-apply often (every 2 hours) and after swimming, excessive perspiration and washing to ensure maximum sun protection.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 6.46%
Ethylhexyl Methoxycinnamate 3.00%

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Water, Butylene Glycol, C12-15 Alkyl Benzoate, Dimethicone, Glycerin, Hydrogenated Polydecene, PEG-10 Dimethicone, Bis-PEG-18 Methyl Ether Dimethyl Silane, Dimethicone/Vinyl Dimethicone Crosspolymer, Polymethyl Methacrylate, Sorbitan Sesquioleate, Hydrogenated Castor Oil Dimer Dilinoleate, Caprylic/Capric Triglyceride, Ozokerite, Sodium Chloride, CI 77492, Tocopheryl Acetate, Aluminum Hydroxide, Triethoxycaprylylsilane, CI 77499, Ethylhexylglycerin, Lactobacillus/Soybean Ferment Extract

PURPOSE

OTC - PURPOSE SECTION

Sunscreen

WARNINGS

WARNINGS SECTION

For external use only. Avoid contact with eyes. Discontinue use if signs of irritation or rashes appear. Replace the cap after use. Keep out of reach of children

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

Uses

INDICATIONS & USAGE SECTION

BB CREAM : Offering natural-looking coverage with a flawless finish, our top-rated tinted moisturizer BB (Blemish Balm) cream can use this gentle tinted moisturizer for sensitive skin as well as normal, combination, oily, acne-prone or dry skin. Made with Hydro colloidal oat, this daily facial Blemish Balm provides UVA and UVB sun protection to help prevent sunburns and signs of premature skin aging

Directions

DOSAGE & ADMINISTRATION SECTION

BB Cream protects skin with SPF 15 so you can wear a moisturizer and sunscreen in one convenient beauty product. ■ Apply on all exposed areas 15-20 minutes before sun exposure. ■ Re-apply often (every 2 hours) and after swimming, excessive perspiration and washing to ensure maximum sun protection.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-138809722151456GTIN-13: 8809722151456
EAN-13: 8809722151456
GTIN storage (14 digits): 08809722151456		bb carton.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73113-050-022022-07-29C16284748780-1e4f33bdf-a7d5-d8a0-e053-dadaa90a6e4e8195c06c-3fd4-4609-a026-bf91e0b62278

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73113-050-01PEDATOSOL OATTBE SYN BIO BETA GLUCANS DERMA BLEMISH BALM50 mL in 1 CONTAINERCREAM501
73113-050-02PEDATOSOL OATTBE SYN BIO BETA GLUCANS DERMA BLEMISH BALM1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73113-050PEDATOSOL OATTBE SYN BIO BETA GLUCANS DERMA BLEMISH BALM (TITANIUM DIOXIDE, ETHYLHEXYL METHOXYCINNAMATE) CREAM [MH GLOBAL CO., LTD.]1Legacy NDC, 2 package rows20210108_8195c06c-3fd4-4609-a026-bf91e0b62278.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73113-05073113-050-01, 73113-050-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
Titanium Dioxide15FIX9V2JPACTIB
OCTINOXATE4Y5P7MUD51ACTIB
Water059QF0KO0RIACT
Butylene Glycol3XUS85K0RAIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
Dimethicone92RU3N3Y1OIACT

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
b16a51f6-b7ca-4b62-a179-9769a09029578195c06c-3fd4-4609-a026-bf91e0b622782021-01-08WarningsExact identifier
spl id: b16a51f6-b7ca-4b62-a179-9769a0902957
spl set id: 8195c06c-3fd4-4609-a026-bf91e0b62278

Reported adverse events (FAERS/openFDA)#

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