ANTI-AGING DAILY MOISTURIZER SUNSCREEN 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 Daily Moisturizer Sunscreen Broad-Spectrum SPF 30

Drug Facts


Purpose

Sunscreen

Active ingredients:

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

Uses:

Warnings:

For external use only

Do not use

on damaged or broken skin.

Stop use and ask a doctor

if rash occurs.

When using this product

keep out of eyes.  Rinse with water to remove.

Keep out of reach of children.

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

Directions:

Inactive ingredients:

WATER (AQUA), ISOPROPYL PALMITATE, ISOEICOSANE, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, POTASSIUM CETYL PHOSPHATE, GLYCERIN, CETYL DIMETHICONE, ETHYHEXYL METHOXYCRYLENE, SILICA, DIMETHICONE, POLYGLYCERYL-3 DIISOSTEARATE, CETEARYL ALCOHOL, HYDROXYETHYLCELLULOSE, PHENOXYETHANOL, GLYCERYL STEARATE, PEG-100 STEARATE, CAPRYLYL GLYCOL, ETHYLHEXYLGLYCERIN, HEXYLENE GLYCOL, TETRAHEXYLDECYL ASCORBATE, TOCOPHERYL ACETATE, BUTYLENE GLYCOL, CAMELIA OLEIFERA LEAF EXTRACT, PUNICA GRANATUM FRUIT EXTRACT.

Other information:

Anti-Aging Daily Moisturizer  Sunscreen Broad-Spectrum SPF 30  Paraben-free  Sulfate-free    2.0 FL OZ  59mL   MADE IN USA   A light easily absorbed SPF day creme formulated with Antioxidants and Extracts of White Tea and Pomegranate.

Anti-Aging Daily Moisturizer Sunscreen Broad-Spectrum SPF 30 2oz/59ml (61016-0003-2)

image description

ANTI-AGING DAILY MOISTURIZER SUNSCREEN BROAD-SPECTRUM SPF 30 
avobenzone, octinoxate, octisalate, oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61016-0003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE40 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
ISOEICOSANE (UNII: AR294KAG3T)  
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
GLYCERIN (UNII: PDC6A3C0OX)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
POMEGRANATE (UNII: 56687D1Z4D)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61016-0003-259 mL in 1 BOTTLE; Type 0: Not a Combination Product04/19/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/19/2012
Labeler - Columbia Cosmetics Manufacturing, Inc. (068267863)
Establishment
NameAddressID/FEIBusiness Operations
Columbia Cosmetics Manufacturing, Inc.068267863manufacture(61016-0003)

Revised: 10/2021
Document Id: cf47b4fc-c0e2-65f4-e053-2995a90a8885
Set id: d644d41c-30f3-49e5-a3b7-1fe16ddac29f
Version: 3
Effective Time: 20211026
 
Columbia Cosmetics Manufacturing, Inc.