Timeless Age Defying SPF 20 Merle Norman

Dosage form: cream
Ingredients: OCTINOXATE 2.25g in 30mL, OXYBENZONE .6g in 30mL
Labeler: Merle Norman
NDC Code: 57627-115

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.

Timeless Age-Defying Makeup SPF 20

Active ingredients

Octinoxate 7.5%
Oxybenzone 2.0%

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

· Keep out of reach of children. If product is swallowed, get medical help or
contact a Poison Control Center right away.

Stop use and ask a doctor if rash occurs


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.

Directions

For sunscreen use:

· Apply liberally 15 minutes before sun exposure

· Use a water resistant sunscreen if swimming or sweating

· Reapply at least every 2 hours

· 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 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
· Children under 6 months: Ask a doctor

Inactive ingredients: Water (Aqua), Titanium Dioxide, Butylene Glycol, Octldodecyl Neopentanoate, Cyclopentasoloxane, Isodecyl Neopentanoate, Iron Oxides, Stearic Acid, Phenyl Trimethicone, Propylene Glycol Stearate SE, Squalane, Triethanolamine, Dipalmitoyl Hydroxyproline, Trilaurin, Ceramide 3, Hyaluronic Acid, Glycine Soja, ( Soybean) Seed Extract, Atelocollagen, Sodium Hyaluronate, Palmitoyl Oligopeptide, Ascorbyl Palmitate, Tocopheryl Acetate, Propylene Glycol Dipelargonate, Ethylene/ Acrylic Acid Copolymer, Panthenol, Allantoin, Lecithin, Glyceryl Polymethacrylate, Dimethionol, Cetyl Phosphate, Tricaprylin, Mica ( Cl 77019), Stearyl Alcohol, PEG-8, Cellulose gum, PEG-12 Dimethicone, Silica, Polyquaternium-24, Sodium Chondroitin Sulfate, Magnesium Aluminum Silicate, Carbomer, Polysorbate 20, Tetrasodium EDTA, Disodium EDTA, Diazolidinyl Urea, BHT, Ethylene Dodecanedioate Phenoxyethanol

Timeless

Age-Defying Makeup SPF 20

Merle Norman

30 mL 1 FL. OZ.

TIMELESS AGE DEFYING SPF 20  MERLE NORMAN
octinoxate, oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57627-115
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE2.25 g  in 30 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE.6 g  in 30 mL
Inactive Ingredients
Ingredient NameStrength
TITANIUM DIOXIDE 
1,3-BUTYLENE GLYCOL 
ISODECYL NEOPENTANOATE 
FERROUS OXIDE 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
FERROSOFERRIC OXIDE 
STEARIC ACID 
PHENYL TRIMETHICONE 
SQUALANE 
TROLAMINE 
DIPALMITOYL HYDROXYPROLINE 
TRILAURIN 
CERAMIDE 3 
HYALURONIC ACID 
SOYBEAN 
HYALURONATE SODIUM 
PALMITOYL OLIGOPEPTIDE 
ASCORBYL PALMITATE 
.ALPHA.-TOCOPHEROL ACETATE, D- 
PANTHENOL 
ALLANTOIN 
CETYL PHOSPHATE 
TRICAPRYLIN 
MICA 
STEARYL ALCOHOL 
POLYETHYLENE GLYCOL 400 
CARBOXYMETHYLCELLULOSE SODIUM 
PEG-12 DIMETHICONE (300 CST) 
SILICON DIOXIDE 
MAGNESIUM ALUMINUM SILICATE 
POLYSORBATE 20 
EDETATE SODIUM 
EDETATE DISODIUM 
DIAZOLIDINYL UREA 
BUTYLATED HYDROXYTOLUENE 
Packaging
#Item CodePackage Description
1NDC:57627-115-021 BOTTLE (BOTTLE) in 1 BOX
1NDC:57627-115-0130 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/05/2011
Labeler - Merle Norman (008479388)
Registrant - Merle Norman (008479388)
Establishment
NameAddressID/FEIOperations
Merle Norman008479388manufacture(57627-115)

Revised: 02/2014
 
Merle Norman

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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