CHINA DOLL FOUNDATION BROAD SPECTRUM SPF 15 cream

CHINA DOLL FOUNDATION BROAD SPECTRUM SPF 15 by

Drug Labeling and Warnings

CHINA DOLL FOUNDATION BROAD SPECTRUM SPF 15 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

Titanium Dioxide 4.5%
Zinc Oxide 2.97%

Purpose

Sunscreen

Uses

Helps prevent sunburn. Higher SPF gives more sunburn protection.

Warnings

For external use only.

When using this product:

keep out of eyes. Rinse with water to remove.

Stop use and see a doctor if

rash or irritation develops and lasts.

Directions

Apply evenly before sun exposure. Children under 6 months of age: ask a doctor. Reapply as needed or after towel drying, swimming or sweating.

Other Information

Moderate sun protection product. Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.

Inactive ingredients

WATER, (AQUA), ISODODECANE, OCTYLDODECYL NEOPENTANOATE, CYCLOPENTASILOXANE, BUTYLENE GLYCOL, POLYGLYCERYL-4 ISOSTEARATE, DIMETHICONE CROSSPOLYMER, SILICA, NYLON-12, TALC, DIMETHICONE CROSSPOLYMER-3, DISTEARDIMONIUM HECTORITE, SODIUM CHLORIDE, PEG/PPG 18/18 DIMETHICONE, CETYL PEG/PPG-10/1 DIMETHICONE, HEXYL LAURATE, TRIETHOXYCAPRYLYLSILANE, POLYDODECANAMIDEAMINIUM TRIAZADIPHENYLETHENESULFONATE, POLYVINYLALCOHOL CROSSPOLYMER, PROPYLENE CARBONATE, CHONDRUS CRISPUS (CARRAGEENAN), XANTHAN GUM, ALOE BARBADENSIS LEAF EXTRACT, PHYTANTRIOL, RETINYL PALMITATE, TOCOPHEROL, TETRAHEXYLDECYL ASCORBATE, SODIUM HYALURONATE, SODIUM DEHYDROACETATE, PHENOXYETHANOL, METHYLPARABEN, PROPYLPARABEN, STEARIC ACID, ALUMINUM HYDROXIDE, MAGNESIUM CHLORIDE, POTASSIUM CHLORIDE, ZINC CHLORIDE, LYSINE, MICA (CI 77019), IRON OXIDES (CI 77491, CI 77492, CI 77499), TITANIUM DIOXIDE (CI 77891).

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.

Product Labels

INGREDIENTS AND APPEARANCE

CHINA DOLL FOUNDATION BROAD SPECTRUM SPF 15 
china doll foundation broad spectrum spf 15 cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59735-500
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	2.97 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	4.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PHYTANTRIOL (UNII: 8LVI07A72W)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
TOCOPHEROL (UNII: R0ZB2556P8)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
FERRIC OXIDE RED (UNII: 1K09F3G675)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TALC (UNII: 7SEV7J4R1U)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
NYLON-12 (UNII: 446U8J075B)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CARRAGEENAN (UNII: 5C69YCD2YJ)
LYSINE (UNII: K3Z4F929H6)
MICA (UNII: V8A1AW0880)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
WATER (UNII: 059QF0KO0R)
ISODODECANE (UNII: A8289P68Y2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
XANTHAN GUM (UNII: TTV12P4NEE)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
METHYLPARABEN (UNII: A2I8C7HI9T)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
ZINC CHLORIDE (UNII: 86Q357L16B)

Product Characteristics
Color	white (LOOK 3)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59735-500-01	1 in 1 CARTON	12/12/2013
1		30 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		032870270	manufacture(59735-500)

Establishment
Name	Address	ID/FEI	Business Operations
MANA PRODUCTS, INC.		078870292	manufacture(59735-500)