PROTECTOR R PLUS- octinoxate, titanium dioxide, oxybenzone cream

Protector by

Drug Labeling and Warnings

Protector by is a Otc medication manufactured, distributed, or labeled by Zenith Medicosm SL. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Octinoxate 7.5%

Titanium Dioxide 25%

Oxybenzone 6%

Description

Made with plant squalene, marine collagen and hyaluronic acid, intensive cream with double moisturizing control provides an overall reduction of signs of ageing by progressively activating natural defence mechanisms. It strenghtens the moisture barrier and favours the skin regeneration process.  Suitable for use on very dry, dehydrated skin with wrinkles and lack of elasticity.

200ml. 6.8 fl. Oz

Warning

TOPICAL USE

PROFESSIONAL USE

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PROTECTOR  R PLUS
octinoxate, titanium dioxide, oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42248-124
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	15 mL  in 200 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	50 mL  in 200 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	12 mL  in 200 mL

Inactive Ingredients
Ingredient Name	Strength
ALUMINUM OXIDE (UNII: LMI26O6933)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)
WATER (UNII: 059QF0KO0R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
WHITE WAX (UNII: 7G1J5DA97F)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
GLYCERIN (UNII: PDC6A3C0OX)
TROLAMINE (UNII: 9O3K93S3TK)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
HYDROLYZED ELASTIN, BOVINE, ALKALINE (1000 MW) (UNII: ZR28QKN0WT)
CARBOMER 934 (UNII: Z135WT9208)
IMIDUREA (UNII: M629807ATL)
EDETATE DISODIUM (UNII: 7FLD91C86K)
METHYLPARABEN (UNII: A2I8C7HI9T)
COLLAGEN, SOLUBLE, FISH SKIN (UNII: 8JC99XGU4W)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
ETHYLPARABEN (UNII: 14255EXE39)
(2-CARBETHOXYETHYL)DIETHOXY(METHYL)SILANE (UNII: N28HAC3H5P)
HYDROXYPROLINE (UNII: RMB44WO89X)
ASPARTIC ACID (UNII: 30KYC7MIAI)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42248-124-01	200 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/01/2011

Labeler - Zenith Medicosm SL (464239694)

Registrant - Zenith Medicosm SL (464239694)

Establishment
Name	Address	ID/FEI	Business Operations
Zenith Medicosm SL		464239694	manufacture