LIVESTS MOIST FOUNDATION 121- titanium dioxide liquid

LIVESTS MOIST FOUNDATION 121 by

Drug Labeling and Warnings

LIVESTS MOIST FOUNDATION 121 by is a Otc medication manufactured, distributed, or labeled by ARSOA HONSHA CORPORATION, NIPPON SHIKIZAI, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Titanium dioxide 10.2%

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.
• higher SPF gives more sunburn protection.
• provides moderate protection against sunburn and tanning.

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.

Stop use and ask a doctor if rash or irritation develops and lasts.

• side effects occur. You may report side effects to FDA at 1-800-FDA-1088.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

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 from10a.m.-2p.m.
• wear long-sleeved shirts, pants, hats, and sunglasses.
• Shake well before use.
• Use a normal foundation.
• Apply liberally and evenly 15 minutes before sun exposure.
• Reapply as needed or after towel drying, swimming or perspiring.
• Children under 6 months of age: ask a doctor.

Inactive ingredients

water, cyclopentasiloxane, butylene glycol, Cl 77891, talc, titanium dioxide, octyldodecyl neopentanoate, glycerin, phenyltrimethicone, peg-9 polydimethylsiloxyethyl dimethicone, cetyl ethylhexanoate, neopentyl glycol diethylhexanoate, dimethicone, mica, acrylates/dimethicone copolymer, aluminum hydroxide, Cl 77492, betaine, polymethylsilsesquioxane, phytosteryl/isostearyl/cetyl/stearyl/behenyl dimer dilinoleate, dimethicone/vinyl dimethicone crosspolymer, stearic acid, sodium chloride, phenoxyethanol, polyglyceryl-2 triisostearate, Cl 77491, triethoxycaprylylsilane, CI77499, tocopherol, hydrogen dimethicone, hydroxyapatite, stearyl glycyrrhetinate, hydroxyproline, squalane, phytosteryl/ocfyldodecyl lauroyl glutamate, phytosteryl macadamiate, zinc oxide, palmitoyl proline, glycyrrhiza glabra(licorice) root extract, sodium palmitoyl sarcosinate, magnesium palmitoyl glutamate, palmitic acid, alumina, saxifraga sarmentosa extract, cynara scolymus (artichoke) leaf extract

Other Information

• protect the product in this container from excessive heat and direct sun.

Principal Display Panel - 20 mL Carton Label

LIVEST'S

MOIST LIQUID FOUNDATION 121

Liqud Foundation SUNSCREEN

BROAD SPECTRUM

SPF 15

Warnings:

The safety of this product has not been determined.

NET 0.67 FL.OZ.

(20 ML)

INGREDIENTS AND APPEARANCE

LIVESTS MOIST FOUNDATION 121 
titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55655-269
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP)	Titanium dioxide	2.31 g  in 20 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TALC (UNII: 7SEV7J4R1U)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
GLYCERIN (UNII: PDC6A3C0OX)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C)
DIMETHICONE (UNII: 92RU3N3Y1O)
MICA (UNII: V8A1AW0880)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
BETAINE (UNII: 3SCV180C9W)
PHYTOSTERYL/ISOSTEARYL/CETYL/STEARYL/BEHENYL DIMER DILINOLEATE (UNII: 8N725H4EFN)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
STEARIC ACID (UNII: 4ELV7Z65AP)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYGLYCERYL-2 TRIISOSTEARATE (UNII: 68DUY2D39A)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TOCOPHEROL (UNII: R0ZB2556P8)
HYDROXYPROLINE (UNII: RMB44WO89X)
SQUALANE (UNII: GW89575KF9)
PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE (UNII: 65954KGO9Q)
PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M)
ZINC OXIDE (UNII: SOI2LOH54Z)
PALMITOYL PROLINE (UNII: I49727TDYF)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
SODIUM PALMITOYL SARCOSINATE (UNII: 7297LY09YF)
MAGNESIUM PALMITOYL GLUTAMATE (UNII: DH37YM1F48)
PALMITIC ACID (UNII: 2V16EO95H1)
ALUMINUM OXIDE (UNII: LMI26O6933)
SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H)
CYNARA SCOLYMUS LEAF (UNII: B71UA545DE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55655-269-31	1 in 1 BOX	12/09/2016
1		20 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/09/2016

Labeler - ARSOA HONSHA CORPORATION (694245452)

Establishment
Name	Address	ID/FEI	Business Operations
NIPPON SHIKIZAI, INC		694869178	ANALYSIS(55655-269) , LABEL(55655-269) , MANUFACTURE(55655-269) , PACK(55655-269) , PARTICLE SIZE REDUCTION(55655-269) , RELABEL(55655-269) , REPACK(55655-269) , STERILIZE(55655-269)