Anti-Aging Tinted Moisturizer 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: 61016-0001

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 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)

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 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 ) OXYBENZONE 4 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ISOEICOSANE 
POTASSIUM CETYL PHOSPHATE 
CETOSTEARYL ALCOHOL 
DIMETHICONE 
GLYCERIN 
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) 
SILICON DIOXIDE 
SORBITAN SESQUIOLEATE 
ISOHEXADECANE 
PHENOXYETHANOL 
CAPRYLYL GLYCOL 
ETHYLHEXYLGLYCERIN 
POLYSORBATE 60 
HEXYLENE GLYCOL 
TITANIUM DIOXIDE 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
FERROSOFERRIC OXIDE 
Packaging
#Item CodePackage Description
1NDC:61016-0001-145 mL in 1 TUBE
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/FEIOperations
Columbia Cosmetics Manufacturing, Inc.068267863manufacture

Revised: 02/2012
 
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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