FARMASI BB- avobenzone, octinoxate, homosalate, octocrylene cream

Farmasi BB by

Drug Labeling and Warnings

Farmasi BB by is a Otc medication manufactured, distributed, or labeled by TAN ALIZE KOZMETIK VE TEMIZLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts:

Active Ingredient:

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

Purpose

Sunscreen

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

Warnings:

For external use only.

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 occurs.

Keep out of reach of children.

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

Directions:

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:

• Protect this product from excessive heat and direct sun. May stain some fabrics.

Inactive Ingredients:

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?

info@farmasius.com (833) 432-7627

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

Package Labeling:

INGREDIENTS AND APPEARANCE

FARMASI BB 
avobenzone, octinoxate, homosalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78317-056
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	29.5 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	73.5 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	97.9 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	61.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
PEG-100 STEARATE (UNII: YD01N1999R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERIN (UNII: PDC6A3C0OX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DIMETHICONE (UNII: 92RU3N3Y1O)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TREHALOSE (UNII: B8WCK70T7I)
UREA (UNII: 8W8T17847W)
SERINE (UNII: 452VLY9402)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM ALGINATE (UNII: C269C4G2ZQ)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PULLULAN (UNII: 8ZQ0AYU1TT)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78317-056-00	1 in 1 CARTON	10/03/2023
1		150 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	10/03/2023

Labeler - TAN ALIZE KOZMETIK VE TEMIZLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI (365979587)