NOTE BB CONCEALER 01- octinoxate cream

Note BB Concealer 01 by

Drug Labeling and Warnings

Note BB Concealer 01 by is a Otc medication manufactured, distributed, or labeled by ALTONA COSMETICS TECHNOLOGY SANAYI VE TICARET ANONIM SIRKETI. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Octinoxate 0.6%

Purpose

Sunscreen

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

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

• 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

• Protect the product in this container from excessive heat and direct sun

Inactive ingredients

Cyclopentasiloxane, Water (Aqua), PEG-10 Dimethicone, Butylene Glycol, Dimethicone, HDI/Trimethylol Hexyllactone Crosspolymer, Disteardimonium Hectorite, Aluminum Starch Octenylsuccinate, Phenoxyethanol, Alcohol, Triethoxycaprylylsilane, Glycerin, Tocopheryl Acetate, Trimethylsiloxysilicate, Bran (Triticum vulgare) Extract, Sodium Chloride, Dimethicone/Vinyl Dimethicone Crosspolymer, Propylene Glycol, Ethylhexylglycerin, Silica, BHT, Bitter Orange(Citrus aurantium) Fruit Extract, Grapefruit (Citrus paradisi) Fruit Extract, Lecithin, Sorbitol, Sodium Ascorbate, Sunflower (Helianthus annus) Seed Oil, Tocopherol, Sodium Hydroxide. May contain: Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499)

Package Labeling:

INGREDIENTS AND APPEARANCE

NOTE BB CONCEALER 01 
octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70474-015
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	6 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GRAPEFRUIT (UNII: O82C39RR8C)
WHEAT (UNII: 4J2I0SN84Y)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE, UNSPECIFIED (UNII: 92RU3N3Y1O)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALCOHOL (UNII: 3K9958V90M)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
BITTER ORANGE (UNII: DQD16J2B5O)
SORBITOL (UNII: 506T60A25R)
SODIUM ASCORBATE (UNII: S033EH8359)
SUNFLOWER OIL (UNII: 3W1JG795YI)
TOCOPHEROL (UNII: R0ZB2556P8)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70474-015-01	1 in 1 CARTON	01/29/2023
1		10 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	01/29/2023

Labeler - ALTONA COSMETICS TECHNOLOGY SANAYI VE TICARET ANONIM SIRKETI (502657469)

Establishment
Name	Address	ID/FEI	Business Operations
ALTONA COSMETICS TECHNOLOGY SANAYI VE TICARET ANONIM SIRKETI		502657469	manufacture(70474-015)