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

Farmasi BB Beauty Balm Cream SPF 15- 01 Light by

Drug Labeling and Warnings

Farmasi BB Beauty Balm Cream SPF 15- 01 Light by is a Otc medication manufactured, distributed, or labeled by Farmasi US LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74690-040
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	35 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74690-040-00	1 in 1 CARTON	07/01/2023
1		30 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	07/01/2023

Labeler - Farmasi US LLC (113303351)