FDA.reportPublic FDA data

Farmasi BB Cream

Manufacturer
TAN ALIZE KOZMETIK VE TEMIZLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI
Effective date
2023-11-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:58:51

Label at a glance#

ProductFarmasi BB
Active ingredientAVOBENZONE, OCTINOXATE, HOMOSALATE, OCTOCRYLENE
Label structure8 sections

Indications and uses

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

Dosage and administration

For Sunscreen Use Apply generously 15 minutes before sun exposure. Reapply at least every 2 hours. Reapply atleast every 2 hours. Use a water resistant sunscreen if swimming or sweating.  Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including. Sun Pro...

Label contents#

Full prescribing information#

Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

Butyl Methoxydibenzoylmethane 2.95% Ethylhexyl Methoxycinnamate 7.35% Homosalate 9.79% Octocrylene 6.15%


Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses:

INDICATIONS & USAGE SECTION

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

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 if

OTC - STOP USE SECTION

rash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions:

DOSAGE & ADMINISTRATION SECTION

For Sunscreen Use

  • Apply generously 15 minutes before sun exposure. Reapply at least every 2 hours.
  • Reapply atleast every 2 hours.
  • Use a water resistant sunscreen if swimming or sweating.
  •  Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including. Sun Protection Measures:
  • 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 this product from excessive heat and direct sun. May stain some fabrics.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Water/Aqua, C 12-15 Alkyl Benzoate, Peg-100 Stearate, Glyceryl Stearate, Cetearyl Alcohol, Glycerin, Silica, Cyclopentasiloxane, Ceteareth-20, Dicaprylyl Carbonate, Ethylhexyl Palmitate, Phenoxyethanol, Dimethicone, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Ethylhexylglycerin, Tocopheryl Acetate, Trehalose, Urea, Serine, Pentylene Glycol, Xanthan Gum, Algin, Caprylyl Glycol, Sodium Hyaluronate, Pullulan, Disodium EDTA, Triethanolamine.

Questions or Comments?

OTC - QUESTIONS SECTION

info@farmasius.com (833) 432-7627

Monday - Friday (9 a.m - 9 p.m. EST)

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer LabelOuter LabelInner LabelInner Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78317-056-00Farmasi BB1 in 1 CARTONCREAM12
78317-056-00Farmasi BB150 mL in 1 TUBECREAM1502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78317-056FARMASI BB (AVOBENZONE, OCTINOXATE, HOMOSALATE, OCTOCRYLENE) CREAM [TAN ALIZE KOZMETIK VE TEMIZLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI]2Current NDC, 2 package rows20231106_042817f9-675e-056a-e063-6394a90a2d97.zip

Products#

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

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78317-05678317-056-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
PEG-100 STEARATEYD01N1999RIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
GLYCERINPDC6A3C0OXIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
CYCLOMETHICONE 50THT5PCI0RIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
ETHYLHEXYL PALMITATE2865993309IACT
PHENOXYETHANOLHIE492ZZ3TIACT
DIMETHICONE92RU3N3Y1OIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TREHALOSEB8WCK70T7IIACT
UREA8W8T17847WIACT
SERINE452VLY9402IACT
PENTYLENE GLYCOL50C1307PZGIACT
XANTHAN GUMTTV12P4NEEIACT
SODIUM ALGINATEC269C4G2ZQIACT
CAPRYLYL GLYCOL00YIU5438UIACT
HYALURONATE SODIUMYSE9PPT4THIACT
PULLULAN8ZQ0AYU1TTIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
TROLAMINE9O3K93S3TKIACT
AVOBENZONEG63QQF2NOXACTIB
OCTINOXATE4Y5P7MUD51ACTIB
HOMOSALATEV06SV4M95SACTIB
OCTOCRYLENE5A68WGF6WMACTIB

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
Farmasi BBAVOBENZONE, OCTINOXATE, HOMOSALATE, OCTOCRYLENETAN ALIZE KOZMETIK VE TEMIZLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI042817f9-675e-056a-e063-6394a90a2d972023-11-05WarningsExact identifier
ndc (package): 78317-056-00
ndc (product): 78317-056
ndc11 (package): 78317005600
spl id: 0973ce0d-48d1-5977-e063-6394a90ad88e
spl set id: 042817f9-675e-056a-e063-6394a90a2d97

Reported adverse events (FAERS/openFDA)#

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