Flormar BB Cream BB01 Fair

Manufacturer
Kosan Kozmetik Sanayi ve Ticaret Anonim Sirketi
Effective date
2019-10-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:00:59

Label at a glance#

ProductFlormar BB BB01 Fair
Active ingredientOCTINOXATE
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

Shake well before use. After use, close the cap properly. 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, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun pr...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 5%

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 damaged 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

OTC - STOP USE SECTION

if rash occurs

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Posion Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Shake well before use.
  • After use, close the cap properly.
  • 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, regularly 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.
  • Children under 6 months of age: Ask a doctor.

Other information

SPL UNCLASSIFIED SECTION

  • Protect the product in this container from excessive heat and direct sun.
  • Keep the product cool.
  • After use, close the tube properly with cap.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Cyclopentasiloxane, Polysilicone-11, Cetyl PEG/PPG-10/1 Dimethicone, Dimethicone, PEG-10 Dimethicone, Trimethylsiloxysilicate, Disteardimonium Hectorite, Glycerin, SD Alcohol 40-B., Polymethylsilsesquioxane, Phenoxyethanol, Methyl Methacrylate Crosspolymer, Sodium Chloride, Fragrance, Sodium PCA, Ethylhexylglycerin, Urea, Algae Extract, Laureth-12, Soluble Collagen, Triethoxycaprylylsilane, Trehalose, Leuconostoc/Radish Root Ferment Filtrate, Aluminum Hydroxide, Polyquaternium-51, Sodium Hyaluronate, Chlorphenesin, Propylene Glycol, Fig (Ficus Carica) Fruit Extract, Cotton (Gossypium Hirsutum) Seed Extract, Linseed (Linum Usitatissimum) Seed Extract, Sodium Dehydroacetate, Caprylyl GLycol, May Contain: Titanium Dioxide, Iron Oxides

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label5Label5

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61722-362-002021-01-29C16284748780-1ba0f9c33-1f70-a910-e053-dadaa90a0b85Flormar BB Cream BB01 Fair

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61722-362-00Flormar BB BB01 Fair35 mL in 1 TUBECREAM352
61722-362-00Flormar BB BB01 Fair1 in 1 BOXCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61722-362FLORMAR BB BB01 FAIR (OCTINOXATE) CREAM [KOSAN KOZMETIK SANAYI VE TICARET ANONIM SIRKETI]2Legacy NDC, 2 package rows20191019_5e288ae2-bb6d-4fe8-96f5-faa37751ab3d.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
61722-36261722-362-00

Ingredients#

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

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

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
95311aaf-c2ff-5a25-e053-2a95a90a83545e288ae2-bb6d-4fe8-96f5-faa37751ab3d2019-10-18WarningsExact identifier
spl id: 95311aaf-c2ff-5a25-e053-2a95a90a8354
spl set id: 5e288ae2-bb6d-4fe8-96f5-faa37751ab3d

Reported adverse events (FAERS/openFDA)#

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