FDA.reportPublic FDA data

Unisex BB Tint- It s Clear - 6552

Manufacturer
Faberlic Joint Stock Company
Effective date
2021-12-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:46:33

Label at a glance#

ProductUnisex BB Tint- It s Clear - 6552
Active ingredientTITANIUM DIOXIDE
Label structure7 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 Children undre 6 months of age: Ask a doctor 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, reguarly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures i...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide, 7.47%

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

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

on damage or broken skin

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove 

Stop use and ask a doctor if

OTC - STOP USE SECTION

rash occurs

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is swallowed get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure
  • Children undre 6 months of age: Ask a doctor
  • 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, reguarly use a sunscreen with a Broad Spectrum 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

SPL UNCLASSIFIED SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aqua/Water, Coco-Caprylate*, Dicaprylyl Carbonate*, Shea Butter Ethyl Ester*, C15-19 Alkane*, Glycerin*, Magnesium Stearate*, Polyglyceryl-6 Polyhydroxystearate*, Polyglyceryl-6 Polyricinoleate*, Silica*, Jojoba Esters*, Persea Gratissima (Avocado) Oil*, Hydrogenated Vegetable Oil*, Sodium Chloride*, Glyceryl Behenate*, Magnesium Sulfate*, Sodium Hyaluronate*, Panax Ginseng Root Extract**, CentellaAsiatica Extract**, Tocopherol*, Polyhydroxystearic Acid*, Phenoxyethanol, Ethylhexylglycerin, Sodium Benzoate, Potassium Sorbate, Parfum/Fragrance, Citric Acid, Iron Oxides Red*, Iron Oxides Black, Iron Oxides Yellow*.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label3Label3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82063-6552-02022-07-29C16284748780-1e4f33bdf-ab46-d8a0-e053-dadaa90a6e4eUnisex BB Tint- It's Clear - 6552

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82063-6552-0Unisex BB Tint- It s Clear - 65521 in 1 CARTONCREAM11
82063-6552-0Unisex BB Tint- It s Clear - 655230 mL in 1 TUBECREAM301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82063-6552UNISEX BB TINT- IT S CLEAR - 6552 (TITANIUM DIOXIDE) CREAM [FABERLIC JOINT STOCK COMPANY]1Legacy NDC, 2 package rows20220111_bf8594e3-e3b4-4c90-b38f-3d9ec3830c5f.zip

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82063-655282063-6552-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
COCO-CAPRYLATE4828G836N6IACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
SHEA BUTTER ETHYL ESTERSV2CI786FPGIACT
C15-19 ALKANECI87N1IM01IACT
GLYCERINPDC6A3C0OXIACT
MAGNESIUM STEARATE70097M6I30IACT
POLYGLYCERYL-6 POLYRICINOLEATEYPM0ZOC2HRIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
AVOCADO OIL6VNO72PFC1IACT
SODIUM CHLORIDE451W47IQ8XIACT
MAGNESIUM SULFATE, UNSPECIFIED FORMDE08037SABIACT
HYALURONATE SODIUMYSE9PPT4THIACT
ASIAN GINSENGCUQ3A77YXIIACT
CENTELLA ASIATICA TRITERPENOIDS4YS74Q4G4JIACT
TOCOPHEROLR0ZB2556P8IACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
SODIUM BENZOATEOJ245FE5EUIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
FERRIC OXIDE RED1K09F3G675IACT
FERROSOFERRIC OXIDEXM0M87F357IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB

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
d418c2d7-bc1f-44aa-e053-2995a90ad9d0bf8594e3-e3b4-4c90-b38f-3d9ec3830c5f2021-12-26WarningsExact identifier
spl id: d418c2d7-bc1f-44aa-e053-2995a90ad9d0
spl set id: bf8594e3-e3b4-4c90-b38f-3d9ec3830c5f

Reported adverse events (FAERS/openFDA)#

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