YOUR NAME TINTED PRIMER BROAD SPECTRUM SPF 20- MEDIUM-DEEP- your name tinted primer cream

YOUR NAME TINTED PRIMER BROAD SPECTRUM SPF 20- MEDIUM-DEEP by

Drug Labeling and Warnings

YOUR NAME TINTED PRIMER BROAD SPECTRUM SPF 20- MEDIUM-DEEP 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]

Actives

Octinoxate 7.5%

Titanium Dioxide 5.00%

Purpose

Sunscreen active

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.

INDICATIONS & USAGE

Stop use and ask a doctor if rash occurs.

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 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 am - 2:00 pm. Wear long sleeved shirts, pants, hats and sunglasses.

INACTIVE INGREDIENTS

Water, Cyclopentasiloxane, Butylene Glycol, Titanium Dioxide, Zinc Oxide, Octyldodecyl Neopentanoate, PEG/PPG-18/18 Dimethicone, Dimethicone, Tocopherol, Tetrahexyldecyl Ascorbate, Retinyl Palmitate, Camellia Sinensis Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Ginkgo Biloba Leaf Extract, Panax Ginseng Root Extract, Octyldodecanol, Boron Nitride, Dextrin Palmitate, Palmitic Acid, Methicone, Stearic Acid, Magnesium Chloride, Potassium Chloride, Sodium Chloride, Zinc Chloride, Magnesium Ascorbyl Phosphate, Sodium Hyaluronate, Phytantriol, Glycerin, Triethoxycaprylylsilane, Lysine, Aluminum Hydroxide, Disodium EDTA, Hexylene Glycol, Potassium Sorbate, Sodium Dehydroacetate, Caprylyl Glycol, Phenoxyethanol

MAY CONTAIN (+/-):

Mica, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499)

OTHER INFORMATION

Protect this product from excessive heat and direct sun.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

YOUR NAME TINTED PRIMER BROAD SPECTRUM SPF 20- MEDIUM-DEEP 
your name tinted primer cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59735-187
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 36 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	5 g  in 36 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ISODODECANE (UNII: A8289P68Y2)
TOCOPHEROL (UNII: R0ZB2556P8)
CERAMIDE NP (UNII: 4370DF050B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE RED (UNII: 1K09F3G675)
LICORICE (UNII: 61ZBX54883)
HYALURONIC ACID (NON-ANIMAL STABILIZED) (UNII: B7SG5YV2SI)
NYLON-12 (UNII: 446U8J075B)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (200 CST) (UNII: 287GF3Y3WC)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
STEARIC ACID (UNII: 4ELV7Z65AP)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
BORON NITRIDE (UNII: 2U4T60A6YD)
METHICONE (20 CST) (UNII: 6777U11MKT)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
OLIVE OIL (UNII: 6UYK2W1W1E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BIS-PEG/PPG-14/14 DIMETHICONE (UNII: X2I70H0QJE)
MICA (UNII: V8A1AW0880)
NYLON 612 (MW 14000) (UNII: E7LN56Z3RX)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59735-187-01	1 in 1 CARTON	02/01/2011
1		36 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 Drug	M020	02/01/2011

Labeler - MANA Products, Inc. (078870292)

Establishment
Name	Address	ID/FEI	Business Operations
MANA Products, Inc.		078870292	manufacture(59735-187)

Establishment
Name	Address	ID/FEI	Business Operations
MANA Products,Inc.		032870270	manufacture(59735-187)