TINTED BB- octinoxate and titanium dioxide cream

Tinted BB by

Drug Labeling and Warnings

Tinted BB by is a Otc medication manufactured, distributed, or labeled by Kareway Product, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Octyl Methoxycinnamate 6%

Titanium Dioxide 8.5%

Purpose

Sunscreen

Sunscreen

Use

helps prevent sunburn

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

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 product is swallowed, get medical help or call a Poison Control Center right away.

Directions

• apply liberally 15 minutes before sun exposure
• reapply at least every 2 hours
• use water resistant sunscreen if swimming or seating
• children under 6 months: ask a doctor

Other information

• protect this product from excessive heat and direct sun

Inactive Ingredients

water, proylene glycol, glycerin, cyclo pentasiloxane, cetyl ethylhexanoate, niacinamide, polysorbate 60, stearic acide, cyclohexasiloxane, glyceryl stearate, cetyl alcohol, sorbitan sesquioleate, dimethicone, triethanolamine, dimethiconol, magnesium aluminum silicate, cl 19140, triethoxycaprylylsilane, betaine, cl 77492, methyparaben, cl 77491, xanthan gum, allantoin, propylparaben, disodium EDTA, cl 77499, tocopheryl acetate, adenosine,

Package label

BB Cream

INGREDIENTS AND APPEARANCE

TINTED BB 
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67510-0378
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	6 mg  in 100 mg
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	8.5 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
NIACINAMIDE (UNII: 25X51I8RD4)
POLYSORBATE 60 (UNII: CAL22UVI4M)
STEARIC ACID (UNII: 4ELV7Z65AP)
CETYL ALCOHOL (UNII: 936JST6JCN)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
DIMETHICONE (UNII: 92RU3N3Y1O)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
BETAINE (UNII: 3SCV180C9W)
METHYLPARABEN (UNII: A2I8C7HI9T)
XANTHAN GUM (UNII: TTV12P4NEE)
ALLANTOIN (UNII: 344S277G0Z)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)
ADENOSINE (UNII: K72T3FS567)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67510-0378-3	40 mg in 1 TUBE; Type 0: Not a Combination Product	10/11/2013
2	NDC: 67510-0378-1	30 mg in 1 TUBE; Type 0: Not a Combination Product	10/11/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	10/11/2013

Labeler - Kareway Product, Inc. (121840057)