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

Timeless Age Defying SPF 20 by

Drug Labeling and Warnings

Timeless Age Defying SPF 20 by is a Otc medication manufactured, distributed, or labeled by Merle Norman. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients          purpose

Octinoxate 7.5%            Sunscreen

Oxybenzone 2.0%         Sunscreen

PURPOSE

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

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

INDICATIONS & USAGE

Stop use and ask a doctor if rash occurs

WARNINGS

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.

DOSAGE & ADMINISTRATION

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 INGREDIENT

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

PRINCIPAL DISPLAY PANEL

Timeless

Age-Defying Makeup SPF 20

Merle Norman

30 mL 1 FL. OZ.

INGREDIENTS AND APPEARANCE

TIMELESS AGE DEFYING SPF 20  MERLE NORMAN
octinoxate, oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57627-115
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.25 g  in 30 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	.6 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57627-115-02	1 in 1 BOX	05/05/2011
1	NDC: 57627-115-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	05/05/2011

Labeler - Merle Norman (008479388)

Registrant - Merle Norman (008479388)

Establishment
Name	Address	ID/FEI	Business Operations
Merle Norman		008479388	manufacture(57627-115)