ANTI-AGING TINTED MOISTURIZER BROAD SPECTRUM SPF 30- avobenzone, octinoxate, octisalate, oxybenzone cream

Anti-Aging Tinted Moisturizer Broad Spectrum SPF 30 by

Drug Labeling and Warnings

Anti-Aging Tinted Moisturizer Broad Spectrum SPF 30 by is a Otc medication manufactured, distributed, or labeled by Columbia Cosmetics Manufacturing, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

AVOBENZONE (3.0%)
OCTINOXATE (7.5%)                                   
OCTISALATE (5.0%)
OXYBENZONE (4.0%)

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

Directions

apply liberally 15 minutes before sun exposure 

use a water-resistant sunscreen if swimming or sweating 

reapply at least every 2 hours 

children under 6 months: Ask a doctor

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 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-sleeve shirts, pants, hats, and sunglasses

Inactive Ingredients

WATER (AQUA), ISOEICOSANE, POTASSIUM CETYL PHOSPHATE, CETEARYL ALCOHOL, CETYL DIMETHICONE, DIMETHICONE, ETHYHEXYL METHOXYCRYLENE, GLYCERIN, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, SILICA,SORBITAN SESQUIOLEATE, ISOHEXADECANE, PHENOXYETHANOL, CAPRYLYL GLYCOL, ETHYLHEXYLGLYCERIN, POLYSORBATE 60, HEXYLENE GLYCOL,TITANIUM DIOXIDE CI 77891, IRON OXIDES CI 77491, CI 77492, CI 77499.

Other Information

protect this product from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL

Anti-Aging Tinted Moisturizer Sunscreen Broad-spectrum SPF 30   Paraben-free   Oil-free    NET WT. 1.5 OZ (45mL)  Contains the antioxidants Vitamin A and E, and extracts of pomegranate and white tea.  Made in USA.

Anti-Aging Tinted Moisturizer Broad Spectrum SPF 30 45ml (

61016-0001-1)

INGREDIENTS AND APPEARANCE

ANTI-AGING TINTED MOISTURIZER BROAD SPECTRUM SPF 30 
avobenzone, octinoxate, octisalate, oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61016-0001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 mg  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 mg  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 mg  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	4 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISOEICOSANE (UNII: AR294KAG3T)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
ISOHEXADECANE (UNII: 918X1OUF1E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
POLYSORBATE 60 (UNII: CAL22UVI4M)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61016-0001-1	45 mL in 1 TUBE; Type 0: Not a Combination Product	02/23/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	02/23/2012

Labeler - Columbia Cosmetics Manufacturing, Inc. (068267863)

Establishment
Name	Address	ID/FEI	Business Operations
Columbia Cosmetics Manufacturing, Inc.		068267863	manufacture(61016-0001)