Protector

Manufacturer: Zenith Medicosm SL
Effective date: 2012-02-21
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 22:30:59

Label at a glance#

ProductProtector R Plus

Active ingredientOCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE

Label structure4 sections

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7.5%

Titanium Dioxide 25%

Oxybenzone 6%

Description

DESCRIPTION SECTION

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

WARNINGS SECTION

TOPICAL USE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
42248-127-02	2019-11-13	C162847	48780-1	97449f38-b97e-f6ea-e053-dbdaa90aa703	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42248-127-02	ProtectorR Plus	1 in 1 BOX	CREAM	1		2
42248-127-02	ProtectorR Plus	50 mL in 1 TUBE	CREAM	50		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42248-127	PROTECTOR R PLUS (OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE) CREAM [ZENITH MEDICOSM SL]	2	Legacy NDC, 2 package rows	20120222_72ac1954-f94e-494c-99cd-3c70a321e45f.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	2
OXYBENZONE	ACTIVE INGREDIENT	95OOS7VE0Y	2
TITANIUM DIOXIDE	ACTIVE INGREDIENT	15FIX9V2JP	2
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	2
OXYBENZONE	ACTIVE MOIETY	95OOS7VE0Y	2
TITANIUM DIOXIDE	ACTIVE MOIETY	15FIX9V2JP	2
(2-CARBETHOXYETHYL)DIETHOXY(METHYL)SILANE	INACTIVE INGREDIENT	N28HAC3H5P	2
ALPHA-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	2
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	2
ASPARTIC ACID	INACTIVE INGREDIENT	30KYC7MIAI	2
BUTYLPARABEN	INACTIVE INGREDIENT	3QPI1U3FV8	2
CARBOMER 934	INACTIVE INGREDIENT	Z135WT9208	2
COLLAGEN, SOLUBLE, FISH SKIN	INACTIVE INGREDIENT	8JC99XGU4W	2
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	2
ETHYLPARABEN	INACTIVE INGREDIENT	14255EXE39	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	2
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	2
HYDROGENATED SOYBEAN LECITHIN	INACTIVE INGREDIENT	H1109Z9J4N	2
HYDROLYZED ELASTIN, BOVINE, ALKALINE (1000 MW)	INACTIVE INGREDIENT	ZR28QKN0WT	2
HYDROXYPROLINE	INACTIVE INGREDIENT	RMB44WO89X	2
IMIDUREA	INACTIVE INGREDIENT	M629807ATL	2
ISOBUTYLPARABEN	INACTIVE INGREDIENT	0QQJ25X58G	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	2
METHYLPARABEN SODIUM	INACTIVE INGREDIENT	CR6K9C2NHK	2
PEG-100 STEARATE	INACTIVE INGREDIENT	YD01N1999R	2
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	2
SODIUM COCOYL ISETHIONATE	INACTIVE INGREDIENT	518XTE8493	2
SODIUM POLYACRYLATE (8000 MW)	INACTIVE INGREDIENT	285CYO341L	2
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	2
WHITE WAX	INACTIVE INGREDIENT	7G1J5DA97F	2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 31 matching rows.

Protector R Plus
OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE
ALUMINUM OXIDE
PROPYLPARABEN
ALPHA-TOCOPHEROL ACETATE
SODIUM COCOYL ISETHIONATE
SODIUM POLYACRYLATE (8000 MW)
METHYLPARABEN SODIUM
WATER
GLYCERYL MONOSTEARATE
PEG-100 STEARATE
WHITE WAX
HYDROGENATED SOYBEAN LECITHIN
GLYCERIN
TROLAMINE
ISOBUTYLPARABEN
HYDROLYZED ELASTIN, BOVINE, ALKALINE (1000 MW)
CARBOMER 934
IMIDUREA
EDETATE DISODIUM
METHYLPARABEN
COLLAGEN, SOLUBLE, FISH SKIN
OCTINOXATE
PHENOXYETHANOL
BUTYLPARABEN
ETHYLPARABEN
TITANIUM DIOXIDE
OXYBENZONE
(2-CARBETHOXYETHYL)DIETHOXY(METHYL)SILANE
HYDROXYPROLINE
ASPARTIC ACID

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
42248-127	42248-127-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ALUMINUM OXIDE	LMI26O6933	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
ALPHA-TOCOPHEROL ACETATE	9E8X80D2L0	IACT
SODIUM COCOYL ISETHIONATE	518XTE8493	IACT
SODIUM POLYACRYLATE (8000 MW)	285CYO341L	IACT
METHYLPARABEN SODIUM	CR6K9C2NHK	IACT
WATER	059QF0KO0R	IACT
GLYCERYL MONOSTEARATE	230OU9XXE4	IACT
PEG-100 STEARATE	YD01N1999R	IACT
WHITE WAX	7G1J5DA97F	IACT
HYDROGENATED SOYBEAN LECITHIN	H1109Z9J4N	IACT
GLYCERIN	PDC6A3C0OX	IACT
TROLAMINE	9O3K93S3TK	IACT
ISOBUTYLPARABEN	0QQJ25X58G	IACT
HYDROLYZED ELASTIN, BOVINE, ALKALINE (1000 MW)	ZR28QKN0WT	IACT
CARBOMER 934	Z135WT9208	IACT
IMIDUREA	M629807ATL	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
COLLAGEN, SOLUBLE, FISH SKIN	8JC99XGU4W	IACT
OCTINOXATE	4Y5P7MUD51	ACTIB
PHENOXYETHANOL	HIE492ZZ3T	IACT
BUTYLPARABEN	3QPI1U3FV8	IACT
ETHYLPARABEN	14255EXE39	IACT
TITANIUM DIOXIDE	15FIX9V2JP	ACTIB
OXYBENZONE	95OOS7VE0Y	ACTIB
(2-CARBETHOXYETHYL)DIETHOXY(METHYL)SILANE	N28HAC3H5P	IACT
HYDROXYPROLINE	RMB44WO89X	IACT
ASPARTIC ACID	30KYC7MIAI	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 7 · 419 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	GRANULE, FOR SUSPENSION / ORAL		80 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	AEROSOL / TOPICAL	3 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	CREAM, AUGMENTED / TOPICAL	10 %w/w		Exact identifier — unii candidate 15 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS	0.02 %w/v		Exact identifier — unii candidate 22 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	LIQUID / ORAL		162 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
CARBOMER 934	CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)	Z135WT9208	SOLUTION / TOPICAL		10 mg	Exact identifier — unii candidate 14 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, EMULSION / INTRAVENOUS		24100 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	POWDER / ORAL	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION / OPHTHALMIC	0.06 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	GEL, METERED / TRANSDERMAL		14 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION/ DROPS / AURICULAR (OTIC)	0.01 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / ORAL	100 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, SOLUTION / INTRAMUSCULAR		4 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / PERIDURAL	1 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET / SUBLINGUAL	1.23 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / AURICULAR (OTIC)	63.64 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CREAM, AUGMENTED / TOPICAL		55 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	CREAM / VAGINAL		40 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	CAPSULE, DELAYED RELEASE / ORAL		15 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	POWDER / ORAL	NA		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SYSTEM / TOPICAL		42 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION, EXTENDED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SPRAY, METERED / NASAL		13 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / INTRAVENOUS		95 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	AEROSOL, FOAM / VAGINAL	0.1 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	CAPSULE / ORAL	2 mg		Exact identifier — unii candidate 3 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / INTRA-ARTICULAR	0.24 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / RECTAL		1808 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	ENEMA / RECTAL		60 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / TOPICAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	CREAM / TOPICAL		57 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
IMIDUREA	IMIDUREA	M629807ATL	SHAMPOO / TOPICAL		60 mg	Exact identifier — unii candidate 3 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / INTRAMUSCULAR	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SYSTEM / IONTOPHORESIS	0.1 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, DELAYED RELEASE / ORAL		100 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / ORAL		432 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / RESPIRATORY (INHALATION)	5 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
BUTYLPARABEN	BUTYLPARABEN	3QPI1U3FV8	SYRUP / ORAL	28.4 mg/1ml		Exact identifier — unii candidate 15 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION / SUBCUTANEOUS	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	AEROSOL, FOAM / TOPICAL	0.16 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	OINTMENT, AUGMENTED / TOPICAL		429 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 79 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CLOTH / TOPICAL	0.05 mg/mg		Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	CONCENTRATE / ORAL	2.5 mg/5ml		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	TABLET / ORAL	0.2 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SYRUP / ORAL		40 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / NASAL	140 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	CREAM, AUGMENTED / TOPICAL		2 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION/ DROPS / OPHTHALMIC	0.13 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	GEL / TOPICAL		4 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	LIQUID / TOPICAL	2.5 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / INTRAVENOUS	0.13 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / RESPIRATORY (INHALATION)		43 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CREAM, AUGMENTED / TOPICAL		2 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / OPHTHALMIC	0.02 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
HYDROGENATED SOYBEAN LECITHIN	HYDROGENATED SOYBEAN LECITHIN	H1109Z9J4N	SUSPENSION / AURICULAR (OTIC)	0.15 %w/v		Exact identifier — unii candidate 4 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, SUSPENSION / SUBCUTANEOUS	0.16 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INTRAVENOUS		6 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	JELLY / TOPICAL		180 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION / AURICULAR (OTIC)	0.01 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
c1540d77-5935-458f-b238-50e2e49b57cf			72ac1954-f94e-494c-99cd-3c70a321e45f	2012-02-21	Warnings	Exact identifier spl id: c1540d77-5935-458f-b238-50e2e49b57cf spl set id: 72ac1954-f94e-494c-99cd-3c70a321e45f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.