TAKE COVER ANTI-AGING FOUNDATION FAIR- octinoxate cream

take cover anti-aging foundation by

Drug Labeling and Warnings

take cover anti-aging foundation by is a Otc medication manufactured, distributed, or labeled by LAURA GELLER MAKE UP INC., Oxygen Development. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Octinoxate 7.0%
Titanium Dioxide 3.50%
Zinc Oxide 1.95%

Purpose

Sunscreen

Use

• 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 generously 15 minutes before sun exposure.
  
• Reapply:
• • after 40 minutes of swimming or sweating
  • immediately after towel drying
  • 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 a broad spectrum SPF value 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-sleeved shirts, pants, hats and sunglasses
• Children under 6 months of age: Ask a doctor.
  

Other Information

• Protect the product in this container from excessive heat and direct sun.
  

Inactive Ingredients

Cyclopentasiloxane,Water(Aqua), Trimethylolpropane, Triisostearate, Dimethicone, Isododecane, PEG/PPG-18/ 18 Dimethicone, Butylene Glycol, Hexyl Laurate, Disteardimonium Hectorite, C12-C15 Alkyl Benzoate, Polyglyceryl-4 Isostearate, Dimethiconol, Dipalmitoyl Hydroxyproline, Dimethicone/Divinyldimethicone/Silses-quioxane Crosspolymer, Polysilicone-11, Phenoxyethanol, Sodium Chloride, Magnesium Aluminium Silicate, PEG-10 Dimethicone, Coco-Caprylate/Caprate, Lecithin, Theobroma Grandiflorum Seed Butter, Cetyl PEG/PPG-10 Dimethicone, Tribehenin, Stearic Acid, Propylene Carbonate, Alumina, Methylparaben, Tocopheryl Acetate, Ceramide 2, PEG-10 Rapeseed Sterol, Triethoxycaprylysilane, Butylparaben, Ethylparaben, Dimethylacrylamide/Acrylic Acid/Polystyrene Ethyl Methacrylate Copolymer, Propylparaben, Decyl Glucoside, Isobutylparaben, Retinyl Palmitate, Tetrahexyldecyl Ascorbate, Caprylyl Glycol, Hexylene Glycol,Laureth-12, Plamitoyl Oligopeptide May Contain:Titanium Dioxide(CI 77891),Mica(CI 77019), Iron Oxides(CI 77492,CI 77491, CI 77499)

Questions or comments?

Call Laura Geller Make-up, Inc., 1(800) MAKE UP4

PRINCIPAL DISPLAY PANEL

LAURA GELLER
BEAUTY INGENUITY
take cover
anti-aging
foundation
broad spectrum
SPF 20
with
Skin Self-Defense
ComplexTM
FAIR
Net Wt.
1 fl. oz./30 ml

INGREDIENTS AND APPEARANCE

TAKE COVER ANTI-AGING FOUNDATION  FAIR
octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51389-113
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.5 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	1.95 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
WATER (UNII: 059QF0KO0R)
TRIMETHYLOLPROPANE (UNII: 090GDF4HBD)
DIMETHICONE (UNII: 92RU3N3Y1O)
ISODODECANE (UNII: A8289P68Y2)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
DIMETHICONOL (250000 MW) (UNII: RKI3S914RT)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
THEOBROMA GRANDIFLORUM SEED BUTTER (UNII: I711F13FXM)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
STEARIC ACID (UNII: 4ELV7Z65AP)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
ALUMINUM OXIDE (UNII: LMI26O6933)
METHYLPARABEN (UNII: A2I8C7HI9T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CERAMIDE 2 (UNII: C04977SRJ5)
PEG-10 RAPESEED STEROL (UNII: 258O76T85M)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
ETHYLPARABEN (UNII: 14255EXE39)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
LAURETH-12 (UNII: OAH19558U1)
PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51389-113-03	29.57 g in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/08/2012

Labeler - LAURA GELLER MAKE UP INC. (199474524)

Establishment
Name	Address	ID/FEI	Business Operations
Oxygen Development		137098492	manufacture