LORAC FOUNDATION MEDIUM SPF20- octinoxate, octisalate, avobenzone emulsion

Lorac Foundation Medium by

Drug Labeling and Warnings

Lorac Foundation Medium by is a Otc medication manufactured, distributed, or labeled by Lorac Cosmetics, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Avobenzone 3.0%

Octinoxate 7.5%

Ocitsalate 5.0%

Purpose

Sunscreen

Uses

• Helps prevent sunburn
• If used as directed with other sun protection measures (See Directions), decreases the rist of skin cancer and early skin-aging cause by the sun.

Warnings

For exteral use Only

• Keep away  from the eye area
• Stop use if irritation occurs
• If irritation persists consult a health practitioner

Keep out of reach of children

Do not use on damaged or broken skin

Directions

Apply 15 minutes prior to sun exposure and reapply as needed

• 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 value at 15 or higher and other sun protection measures including
• Limit time in the sun, expecially from 10 a.m. to 2 p.m.
• Wear long-sleeved shirts, hats, pants 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

WATER, CYCLOPENTASILOXANE, POLYMETHYLSILSESUIOXANE, ETHYLHEXYL PALMITATE, GLYCERIN, NEOPENTYL GLYCOL DIHEPTANOATE, TRIMETHYLSILOXYSILICATE,  HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, QUATERNIUM-90 BENTONITE, MAGNESIUM SULFATE, SODIUM CHLORIDE, SODIUM BENZOATE, POTASSIUM SORBATE, PHENYL TRIMETHICONE, TOCOPHERYL ACETATE, POLYGLYCERYL-3 BEESWAX,  MICROCRYSTALINE WAX, PROPYLENE CARBONATE, RETINYL PALMITATE, POLYHYDROXYSTEARIC ACID, LECITHIN, ISOPROPYL MYRISTATE, ISOSTEARIC ACID, POLYGLYCERYL-3 POLYRICINOLEATE, CETYL PEG/PPG-10/1 DIMETHICONE, POLYGLYCERYL-3 DIISOSTEARATE, OLEA EUROPAEA (OLIVE) LEAF EXTRACT, PHENOXYETHANOL, CAPRYLYL GLYCOL, CHLORPHENESIN, TRIETHOXYCAPRYLYLSILANE, CARICA PAPAYA (PAPAYA) FRUIT EXTRACT, CITRUS MEDICA LIMONUM (LEMON) FRUIT EXTRACT, MAY CONTAIN : TITANIUM DIOXIDE (CI 77891), IRON OXIDES (CI77492, CI 77491, CI 77499), MICA (CI 77019).

Questions or Comments

Call Customer Care 1-800-845-0705

Mon-Fri between 8 am - 4pm PST

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LORAC FOUNDATION MEDIUM  SPF20
octinoxate, octisalate, avobenzone emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52773-238
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5.0 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3.0 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
GLYCERIN (UNII: PDC6A3C0OX)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
HEXAMETHYLENE DIISOCYANATE (UNII: 0I70A3I1UF)
BENTOQUATAM (UNII: 7F465U79Q1)
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ISOSTEARIC ACID (UNII: X33R8U0062)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CARICA PAPAYA WHOLE (UNII: S0U63B0Q51)
CITRUS MEDICA FRUIT (UNII: ZE5Q6PN9ON)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52773-238-02	1 in 1 CARTON	10/01/2013
1	NDC: 52773-238-01	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 not final	part352	10/01/2013

Labeler - Lorac Cosmetics, Inc. (940915473)