TIMELESS AGE DEFYING SPF 20 MERLE NORMAN- octinoxate, oxybenzone cream 
Merle Norman

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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Timeless Age-Defying Makeup SPF 20

Active Ingredients          purpose

Octinoxate 7.5%            Sunscreen

Oxybenzone 2.0%         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

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.

carton

bottle

TIMELESS AGE DEFYING SPF 20  MERLE NORMAN
octinoxate, oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57627-115
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.25 g  in 30 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE.6 g  in 30 mL
Inactive Ingredients
Ingredient NameStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)  
FERROUS OXIDE (UNII: G7036X8B5H)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
SQUALANE (UNII: GW89575KF9)  
TROLAMINE (UNII: 9O3K93S3TK)  
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
TRILAURIN (UNII: 7FP2Z3RVUV)  
CERAMIDE 3 (UNII: 4370DF050B)  
HYALURONIC ACID (UNII: S270N0TRQY)  
SOYBEAN (UNII: L7HT8F1ZOD)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
PANTHENOL (UNII: WV9CM0O67Z)  
ALLANTOIN (UNII: 344S277G0Z)  
CETYL PHOSPHATE (UNII: VT07D6X67O)  
TRICAPRYLIN (UNII: 6P92858988)  
MICA (UNII: V8A1AW0880)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
EDETATE SODIUM (UNII: MP1J8420LU)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57627-115-021 in 1 BOX05/05/2011
1NDC:57627-115-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35205/05/2011
Labeler - Merle Norman (008479388)
Registrant - Merle Norman (008479388)
Establishment
NameAddressID/FEIBusiness Operations
Merle Norman008479388manufacture(57627-115)

Revised: 1/2017
Document Id: 40ef2014-88ce-4b0d-9e2c-fdfc0be386d1
Set id: cae1e33b-d41f-454d-8a16-ff41bd6663dc
Version: 16
Effective Time: 20170123
 
Merle Norman