ANTI-AGING TINTED MOISTURIZER BROAD SPECTRUM SPF 30- avobenzone, octinoxate, octisalate, oxybenzone cream 
Columbia Cosmetics Manufacturing, 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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Anti-Aging Tinted Moisturizer Broad Spectrum SPF 30

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

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)

Columbia Cosmetics Sunscreen

ANTI-AGING TINTED MOISTURIZER BROAD SPECTRUM SPF 30 
avobenzone, octinoxate, octisalate, oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61016-0001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 mg  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 mg  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 mg  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE4 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61016-0001-145 mL in 1 TUBE; Type 0: Not a Combination Product02/23/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35202/23/2012
Labeler - Columbia Cosmetics Manufacturing, Inc. (068267863)
Establishment
NameAddressID/FEIBusiness Operations
Columbia Cosmetics Manufacturing, Inc.068267863manufacture(61016-0001)

Revised: 10/2021
 
Columbia Cosmetics Manufacturing, Inc.