TARTE AMAZONIAN CLAY BB TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN cream

TARTE AMAZONIAN CLAY BB TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN by

Drug Labeling and Warnings

TARTE AMAZONIAN CLAY BB TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by MANA PRODUCT, INC., MANA PRODUCTS, INC., MANA PRODUCTS, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

Titanium Dioxide 5%
Zinc Oxide 5%

PURPOSE

Sunscreen

USES

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 a water resistant sunscreen if swimming or sweating
• Reapply at least every 2 hours
• Children under 6 months: Ask a doctor
• Optional: apply to all skin exposed to the sun
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin 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 a.m.-2 p.m.
• Wear long-sleeved shirts, pants, hats and sunglasses

OTHER INFORMATION

Protect the product in this container from excessive heat and direct sunlight

INACTIVE INGREDIENTS

Water, cyclopentasiloxane, PEG/PPG-18/18 dimethicone, octyldodecyl neopentanoate, glycerin, dimethicone, aluminum hydroxide, stearic acid, phenoxyethanol, mica, boron nitride, sodium dehydroacetate, caprylyl glycol, sodium chloride, phytantriol, kaolin, magnesium ascorbyl phosphate, palmitic acid, dextrin palmitate, sodium hyaluronate, hexylene glycol, retinyl palmitate, tocopheryl acetate, tocopherol, tetrahexyldecyl ascorbate, methicone, butylene glycol, triethoxycaprylylsilane, calcium sodium phosphosilicate, saccharum officinarum (sugar cane) extract, pyrus malus (apple) fruit extract, citrus limon (lemon) fruit extract, citrus aurantium dulcis (orange) fruit extract, camellia oleifera leaf extract, panax ginseng root extract, ginkgo biloba leaf extract, anthemis nobilis flower extract, iron oxides.

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TARTE AMAZONIAN CLAY BB TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 
tarte amazonian clay bb tinted moisturizer broad spectrum spf 20 sunscreen cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59735-460
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	5 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
STEARIC ACID (UNII: 4ELV7Z65AP)
PHYTANTRIOL (UNII: 8LVI07A72W)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
LEMON (UNII: 24RS0A988O)
ORANGE (UNII: 5EVU04N5QU)
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE RED (UNII: 1K09F3G675)
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)
ASIAN GINSENG (UNII: CUQ3A77YXI)
GINKGO (UNII: 19FUJ2C58T)
KAOLIN (UNII: 24H4NWX5CO)
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
PALMITIC ACID (UNII: 2V16EO95H1)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TOCOPHEROL (UNII: R0ZB2556P8)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
SUGARCANE (UNII: 81H2R5AOH3)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MICA (UNII: V8A1AW0880)
BORON NITRIDE (UNII: 2U4T60A6YD)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
APPLE (UNII: B423VGH5S9)

Product Characteristics
Color	white (SHADE LIGHT)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59735-460-01	1 in 1 CARTON	05/01/2004
1		50 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	05/01/2004

Labeler - MANA PRODUCT, INC. (078870292)

Establishment
Name	Address	ID/FEI	Business Operations
MANA PRODUCTS, INC		032870270	manufacture(59735-460)

Establishment
Name	Address	ID/FEI	Business Operations
MANA PRODUCTS, INC.		078870292	manufacture(59735-460)