TINTED BB- octinoxate and titanium dioxide cream 
Kareway Product, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

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

Other information

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

image of sunscreen tube

TINTED BB 
octinoxate and titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0378
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6 mg  in 100 mg
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE8.5 mg  in 100 mg
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67510-0378-340 mg in 1 TUBE; Type 0: Not a Combination Product10/11/2013
2NDC:67510-0378-130 mg in 1 TUBE; Type 0: Not a Combination Product10/11/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35210/11/2013
Labeler - Kareway Product, Inc. (121840057)

Revised: 12/2017
Document Id: 615e314b-120f-4a88-e053-2a91aa0a8cb4
Set id: 0de018dd-549c-4fbd-a5c9-3fbda53e527a
Version: 2
Effective Time: 20171227
 
Kareway Product, Inc.