STICK FOUNDATION SPF DARK COFFEE- stick foundation cream

Stick Foundation SPF DARK COFFEE by

Drug Labeling and Warnings

Stick Foundation SPF DARK COFFEE by is a Otc medication manufactured, distributed, or labeled by MANA PRODUCTS, INC., MANA PRODUCTS, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

OCTINOXATE 7.5%
OCTISALATE 5.0%
TITANIUM DIOXIDE 2.0%

PURPOSE

Sunscreen

USE

Helps to prevent sunburn.

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

Apply liberally 15 minutes before sun exposure
Reapply at least every 2 hours
Use water resistant sunscreen if swimming or sweathing
Sun Protection Measures: Spending time in the sun decreases risk of skin cancer and early again. To decrease this risk, regulaory 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 am - 2:00 pm. Wear long sleeved shirts, pants, hats and sunglasses.
Children under 6 months: ask a doctor

INACTIVE INGREDIENTS

Alumina, Aluminum Hydroxide, Behenyl Alcohol, Butylene Glycol, C12-15 Alkyl Benzoate, Caprylic/Capric/Myristic/Stearic Triglyceride, Caprylyl Glycol, Carbomer, Cellulose Gum, Cety Alcohol, Dextrin Palmitate, Dimethicone, Dimethylacrylamide/Acrylic Acid/Plystyrene Ethyl Methacylate, Disodium EDTA, Ethoxydiglycol, Ethylhexylglycerin, Glycerin, Hexylene Glycol, Hydrogenated Lecithin, Isostearic Acid, Lycium Barbarum Fruit Extract, Lysine, Magnesium Chloride, Nordihydroguaiaretic Acid, Octyldodecyl Neopenanoate, Oleanolic Acid, Palmitoyl Hexapeptide-14, Panthenol, PEG-60 Almond Glycerides, Phenoxyethanol, Phospholipids, Phytantriol, Polygleceryl-3 Diisostearate, Polysorbate 80, Potassium Chloride, Silica, Sodium Benozate, Sodium Chloride, Sodium Dehydroacetate, Sodium Hyaluronate Crosspolymer, Sodium Hydroxide, Squalane, Steareth-2, Steareth-21, Stearic Acid, Superoxide Dismutase, Tetrahexyldecyl Ascorbate, Tocopherol, Tocopheryl Acetate, Triethoxycaprylylsilane, Triethylhexanoin, Water, Xanthan Gum, Zinc Chloride May Contain (+/-): Mica, Iron Oxides.

OTHER INFORMATION

Protect this product form excessive heat and direct sun

INDICATIONS & USAGE

Stop use and ask a doctor if rash occurs.

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.

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

STICK FOUNDATION SPF DARK COFFEE 
stick foundation cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59735-426
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
NYLON-12 (UNII: 446U8J075B)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
OCTYLDODECANOL (UNII: 461N1O614Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
YELLOW WAX (UNII: 2ZA36H0S2V)
CANDELILLA WAX (UNII: WL0328HX19)
PROPYLENE GLYCOL MONOLAURATE (UNII: 668Z5835Z3)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
TOCOPHEROL (UNII: R0ZB2556P8)
SOYBEAN OIL (UNII: 241ATL177A)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59735-426-01	1 in 1 CARTON	12/12/2013
1		14 g 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	12/12/2013

Labeler - MANA PRODUCTS, INC. (078870292)

Establishment
Name	Address	ID/FEI	Business Operations
MANA PRODUCTS, INC.		078870292	manufacture(59735-426)

Establishment
Name	Address	ID/FEI	Business Operations
MANA PRODUCTS, INC		032870270	manufacture(59735-426)