MINERAL LP FOUNDATION OATMEAL- mineral lp foundation cream

MINERAL LP FOUNDATION Oatmeal by

Drug Labeling and Warnings

MINERAL LP FOUNDATION Oatmeal by is a Otc medication manufactured, distributed, or labeled by JENTRY KELLEY, MANA Products, Inc., MANA Products, Inc, MANA Products,Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Actives

Titanium Dioxide 6%

Zinc Oxide 3%

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. Stop use and ask doctor if rash occurs.

INDICATIONS & USAGE

When using this product keep out of eyes. Rinse with water to remove.

KEEP OUT OF REACH OF CHILDREN

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

Directions

Apply liberally 15 minutes before sun exposure. Use a water-resistant sunscreen if swimming or sweating. Reapply at least every 2 hours, Children under 6 months: ask a doctor.

Sun Protection Measures: Spending time in the sun increases risk of skin cancer and early 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 10:00 a.m. - 2:00 p.m. Wear long sleeved shirts, pants, hats, and sunglasses.

Inactive Ingredients

Cyclopentasiloxane, Aqua/Water/Eau, Dimethicone Crosspolymer, Octyldodecyl Neopentanoate, Butylene Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Polyglyceryl-4 Isostearate, Aluminum Hydroxide, Stearic Acid, Dimethicone, Hexyl Laurate, Silica, Tocopherol, Tetrahexyldecyl Ascorbate, Sodium Hyaluronate, PEG/PPG-18/18 Dimethicone, Phytantriol, Nylon-12, Sodium Chloride, Nylon-12 Fluorescent Brightener 230 Salt, Polyvinylalcohol Crosspolymer, Octyldodecanol, Magnesium Chloride, Potassium Chloride, Zinc Chloride , Lysine, Methicone, Triethoxycaprylylsilane, Disodium EDTA, Hexylene Glycol, Caprylyl Glycol, Phenoxyethanol, Potassium Sorbate,Mica ,Titanium Dioxide (CI 77891), Iron Oxides (CI 77492), Iron Oxides (CI 77491), Iron Oxides (CI 77499)

Other Information

Protect this product from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MINERAL LP FOUNDATION OATMEAL 
mineral lp foundation cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84179-208
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	3 g  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	6 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
DIMETHICONE (UNII: 92RU3N3Y1O)
DISODIUM 4,4'-BIS((4-ANILINO-6-((2-CARBAMOYLETHYL)(2-HYDROXYETHYL)AMINO)-S-TRIAZIN-2-YL)AMINO)-2,2'-STILBENEDISULFONATE (UNII: 30I2S866LK)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
ZINC CHLORIDE (UNII: 86Q357L16B)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
LYSINE (UNII: K3Z4F929H6)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
WATER (UNII: 059QF0KO0R)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
METHICONE (20 CST) (UNII: 6777U11MKT)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
STEARIC ACID (UNII: 4ELV7Z65AP)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
NYLON-12 (UNII: 446U8J075B)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 3) (UNII: G300307ZXP)
TOCOPHEROL (UNII: R0ZB2556P8)
PHYTANTRIOL (UNII: 8LVI07A72W)
OCTYLDODECANOL (UNII: 461N1O614Y)
EDETATE DISODIUM (UNII: 7FLD91C86K)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84179-208-01	1 in 1 CARTON	08/01/2011
1		30 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	08/01/2011

Labeler - JENTRY KELLEY (040036679)

Registrant - MANA Products, Inc. (078870292)

Establishment
Name	Address	ID/FEI	Business Operations
MANA Products, Inc		078870292	manufacture(84179-208)

Establishment
Name	Address	ID/FEI	Business Operations
MANA Products,Inc		032870270	manufacture(84179-208)