FARMASI BB BEAUTY BALM CREAM SPF 15- 01 LIGHT- titanium dioxide cream 
Farmasi US LLC

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Farmasi BB Beauty Balm Cream SPF 15- 01 Light

Drug Facts:

Active Ingredient:

Titanium Dioxide 3.5%

Purpose

Sunscreen

Use:

Helps prevent sunburn.

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 the reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. Shake well before use. 

Directions:

 • Apply 15 minutes before sun exposure. • 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. For Sunscreen Use Sun Protection Measures:

Other Information:

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

Inactive Ingredients:

Water/Aqua, Cyclopentasiloxane, Butylene Glycol, PEG-10 Dimethicone, Dimethicone, Disteardimonium Hectorite, Tr i m e t h y l s i l o x y s i l i c a t e , Phenoxyethanol, Phenethyl Alcohol, Sodium Chloride, Sodium Carrageenan, Silica, Sea Salt/Maris Sal, Polymethylsilsesquioxane, Jojoba Esters, Tocopherol, Tocopheryl Acetate, E t h y l h e x y l g l y c e r i n , Triethoxycaprylylsilane, Fragrance. [+/- May Contain: Titanium  Dioxide/77891, Iron Oxides/CI 77491, CI 77492, CI77499.]

Questions or Comments?

info@farmasius.com (833)432-7627 Monday – Friday (9 a.m. - ) p.m. EST)

Package Labeling:

Outer PackageInner Package

FARMASI BB BEAUTY BALM CREAM SPF 15- 01 LIGHT 
titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74690-040
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE35 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
CARRAGEENAN SODIUM (UNII: 7CY8BVL34N)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
TOCOPHEROL (UNII: R0ZB2556P8)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74690-040-001 in 1 CARTON07/01/2023
130 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02007/01/2023
Labeler - Farmasi US LLC (113303351)

Revised: 11/2023
Document Id: 09734a55-efe4-3b22-e063-6394a90ad2d2
Set id: 97c1da03-b79c-46a3-a9f0-7aeb94ed66da
Version: 2
Effective Time: 20231105
 
Farmasi US LLC