NDC 52685-354 Shiseido Advanced Hydro-liquid Compact (refill) I100

Product Information

Product Code	52685-354
Proprietary Name What is the Proprietary Name? The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.	Shiseido Advanced Hydro-liquid Compact (refill) I100
Product Labeler Information What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.	Shiseido Co., Ltd.
Labeler Code	52685
Start Marketing Date What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.	08-01-2011
Listing Expiration Date What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.	12-31-2017
Exclude Flag What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".	I
NDC Code Structure	52685 - Shiseido Co., Ltd. 52685-354 - Shiseido Advanced Hydro-liquid Compact (refill) 52685-354-30

Usage Information

This product is used as Sunscreen

Product Packages

NDC 52685-354-30

Package Description: 1 TRAY in 1 CARTON > 12 g in 1 TRAY

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Product Details

Shiseido Advanced Hydro-liquid Compact (refill) I100 is product labeled by Shiseido Co., Ltd.. The product's dosage form is and is administered via form.

What are Shiseido Advanced Hydro-liquid Compact (refill) I100 Active Ingredients?

The following is the list of active ingredients in this product. An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (Active Moiety)

Inactive Ingredient(s)

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

CYCLOMETHICONE (UNII: NMQ347994Z)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
PARAFFIN (UNII: I9O0E3H2ZE)
PETROLATUM (UNII: 4T6H12BN9U)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
ROSEMARY OIL (UNII: 8LGU7VM393)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
LAVENDER OIL (UNII: ZBP1YXW0H8)
ALUMINUM OXIDE (UNII: LMI26O6933)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
PALMITIC ACID (UNII: 2V16EO95H1)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
BARIUM SULFATE (UNII: 25BB7EKE2E)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
METHICONE (20 CST) (UNII: 6777U11MKT)
TETRADECENE (UNII: FW23481S7S)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CYCLOMETHICONE (UNII: NMQ347994Z)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
PARAFFIN (UNII: I9O0E3H2ZE)
PETROLATUM (UNII: 4T6H12BN9U)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
ROSEMARY OIL (UNII: 8LGU7VM393)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
LAVENDER OIL (UNII: ZBP1YXW0H8)
ALUMINUM OXIDE (UNII: LMI26O6933)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
PALMITIC ACID (UNII: 2V16EO95H1)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
BARIUM SULFATE (UNII: 25BB7EKE2E)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
METHICONE (20 CST) (UNII: 6777U11MKT)
TETRADECENE (UNII: FW23481S7S)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CYCLOMETHICONE (UNII: NMQ347994Z)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
PARAFFIN (UNII: I9O0E3H2ZE)
PETROLATUM (UNII: 4T6H12BN9U)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
ROSEMARY OIL (UNII: 8LGU7VM393)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
LAVENDER OIL (UNII: ZBP1YXW0H8)
ALUMINUM OXIDE (UNII: LMI26O6933)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
PALMITIC ACID (UNII: 2V16EO95H1)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
BARIUM SULFATE (UNII: 25BB7EKE2E)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
METHICONE (20 CST) (UNII: 6777U11MKT)
TETRADECENE (UNII: FW23481S7S)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

* Please review the disclaimer below.

Shiseido Advanced Hydro-liquid Compact (refill) I100 Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

OTHER
ACTIVE INGREDIENT
PURPOSE
USE
WARNINGS
OTC - DO NOT USE
OTC - WHEN USING
OTC - STOP USE
OTC - KEEP OUT OF REACH OF CHILDREN
DIRECTIONS
INACTIVE INGREDIENTS
OTHER INFORMATION
QUESTIONS OR COMMENTS?
PRINCIPAL DISPLAY PANEL - 12G CARTON (B00)
PRINCIPAL DISPLAY PANEL - 12G CARTON (B100)
PRINCIPAL DISPLAY PANEL - 12G CARTON (WB40)
PRINCIPAL DISPLAY PANEL - 12G CARTON (WB60)
PRINCIPAL DISPLAY PANEL - 12G CARTON (I100)
PRINCIPAL DISPLAY PANEL - 12G CARTON (O00)

Other

Drug Facts

Active Ingredient

TITANUIM DIOXIDE 4.5%

Purpose

Sunscreen

Use

helps prevent sunburn

Warnings

For external use only

Otc - Do Not Use

Do not use on damaged or broken skin

Otc - When Using

When using this product keep out of eyes. Rinse with water to remove.

Otc - Stop Use

Stop use and ask a doctor if rash occurs

Otc - 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.

Directions

For sunscreen use:

apply liberally 15 minutes before sun exposure
use a water resistant sunscreen if swimming or sweating
reapply at least every 2 hours
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 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-sleeve shirts, pants, hats, and sunglasses
- children under 6 months: Ask a doctor

Inactive Ingredients

CYCLOMETHICONE, WATER, GLYCERIN, DIMETHICONE, DIPROPYLENE GLYCOL, PARAFFIN, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, SORBITAN SESQUIISOSTEARATE, PETROLATUM, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, MICROCRYSTALLINE WAX, PEG/PPG-36/41 DIMETHYL ETHER, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF OIL, SODIUM HYALURONATE, LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL, POLYSILICONE-2, ALUMINA, HYDROGEN DIMETHICONE, DISTEARYLDIMONIUM CHLORIDE, PALMITIC ACID, PEG-10 DIMETHICONE, ALUMINUM HYDROXIDE, BARIUM SULFATE, TOCOPHEROL, ISOPROPYL ALCOHOL, DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE, METHICONE, TITANIUM DIOXIDE, TETRADECENE, PHENOXYETHANOL, IRON OXIDES, MICA,

Other Information

12g NET WT. .42 OZ.

PRINCIPAL DISPLAY PANEL - 12g Carton (O00) - smk 06