PROTECTOR R PLUS- octinoxate, titanium dioxide, oxybenzone cream
Zenith Medicosm SL

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

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.

50ml. 1.7 fl. Oz

Warning

TOPICAL USE

PROTECTOR R PLUS
octinoxate, titanium dioxide, oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:42248-127
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.75 mL in 50 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	12.5 mL in 50 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	3 mL in 50 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description
Packaging
1	NDC:42248-127-02	1 in 1 BOX
1		50 mL in 1 TUBE

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

Labeler - Zenith Medicosm SL (464239694)

Registrant - Zenith Medicosm SL (464239694)

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