RAE CLIMATE CONTROL MOISTURIZING MINERAL TINT 35%- zinc oxide, titanium dioxide cream

RAE Climate Control Moisturizing Mineral Tint 35% by

Drug Labeling and Warnings

RAE Climate Control Moisturizing Mineral Tint 35% by is a Otc medication manufactured, distributed, or labeled by Rae Cosmetics, Mana Product, Inc, Mana Products,Inc, Mana Products, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

Titanium Dioxide 5.00%

Zinc Oxide 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.

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.

OTHER INFORMATION

Protect this product from exessive heat and direct sun.

INDICATIONS & USAGE

Stop use and ask a doctor if rash occurs.

INACTIVE INGREDIENT

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)

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

RAE CLIMATE CONTROL MOISTURIZING MINERAL TINT 35% 
zinc oxide, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84645-177
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	5 g  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	5 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
TOCOPHEROL (UNII: R0ZB2556P8)
ASIAN GINSENG (UNII: CUQ3A77YXI)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
METHICONE (20 CST) (UNII: 6777U11MKT)
STEARIC ACID (UNII: 4ELV7Z65AP)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BORON NITRIDE (UNII: 2U4T60A6YD)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CHAMOMILE (UNII: FGL3685T2X)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
MICA (UNII: V8A1AW0880)
PALMITIC ACID (UNII: 2V16EO95H1)
WATER (UNII: 059QF0KO0R)
GINKGO (UNII: 19FUJ2C58T)
OCTYLDODECANOL (UNII: 461N1O614Y)
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
HYALURONIC ACID (NON-ANIMAL STABILIZED) (UNII: B7SG5YV2SI)
PHYTANTRIOL (UNII: 8LVI07A72W)
DIMETHICONE (UNII: 92RU3N3Y1O)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)
EDETATE DISODIUM (UNII: 7FLD91C86K)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
FERRIC OXIDE RED (UNII: 1K09F3G675)
ZINC CHLORIDE (UNII: 86Q357L16B)
GLYCERIN (UNII: PDC6A3C0OX)
LYSINE (UNII: K3Z4F929H6)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84645-177-01	1 in 1 CARTON	02/01/2011
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	02/01/2011

Labeler - Rae Cosmetics (361655314)

Registrant - Mana Product, Inc (078870292)

Establishment
Name	Address	ID/FEI	Business Operations
Mana Products,Inc		032870270	manufacture(84645-177)

Establishment
Name	Address	ID/FEI	Business Operations
Mana Products, Inc		078870292	manufacture(84645-177)