Anti-Aging Daily Moisturizer Sunscreen Broad-Spectrum SPF 30

Dosage form: cream
Ingredients: AVOBENZONE 3mL in 100mL, OCTINOXATE 7.5mL in 100mL, OCTISALATE 5mL in 100mL, OXYBENZONE 4mL in 100mL
Labeler: Columbia Cosmetics Manufacturing, Inc.
NDC Code: 61016-0003

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.

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:
  • helps prevent sunburn
  • if used as directed with other sun protection measure (see Directions), decrease 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.

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:
  • 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 value of 15 or higher and other sun protection measures including:
  • limit time in the sun especially from 10 AM to 2 PM
  • wear long-sleeved shirts, pants, hats and sunglasses.

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:
  • protect this product from excessive heat and direct sun.

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)

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 AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (AVOBENZONE) AVOBENZONE3 mL  in 100 mL
OCTINOXATE (OCTINOXATE) OCTINOXATE7.5 mL  in 100 mL
OCTISALATE (OCTISALATE) OCTISALATE5 mL  in 100 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE4 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ISOPROPYL PALMITATE 
ISOEICOSANE 
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) 
POTASSIUM CETYL PHOSPHATE 
GLYCERIN 
SILICON DIOXIDE 
DIMETHICONE 
POLYGLYCERYL-3 DIISOSTEARATE 
CETOSTEARYL ALCOHOL 
PHENOXYETHANOL 
GLYCERYL MONOSTEARATE 
PEG-100 STEARATE 
CAPRYLYL GLYCOL 
ETHYLHEXYLGLYCERIN 
HEXYLENE GLYCOL 
TETRAHEXYLDECYL ASCORBATE 
.ALPHA.-TOCOPHEROL ACETATE 
BUTYLENE GLYCOL 
POMEGRANATE 
Packaging
#Item CodePackage Description
1NDC:61016-0003-259 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/19/2012
Labeler - Columbia Cosmetics Manufacturing, Inc. (068267863)
Establishment
NameAddressID/FEIOperations
Columbia Cosmetics Manufacturing, Inc.068267863manufacture

Revised: 04/2012
 
Columbia Cosmetics Manufacturing, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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