Optimal Tinted Complexion Cream

Manufacturer: Janssen Cosmetics GmbH
Effective date: 2012-09-20
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: legacy-cache
Hydrated at: 2026-08-02 01:45:19

Label at a glance#

ProductOptimal Tinted Complexion

Active ingredientOCTINOXATE

Label structure3 sections

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: ethylhexyl methoxycinnamate 7.0% Purpose: Sunscreen

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Aqua [water], caprylic/capric triglyceride, butylene glycol, dicaprylyl carbonate, C12-15 alkyl benzoate, cetearyl

alcohol, methyl glucose sesquistearate, CI 77891 [titanium dioxide], glyceryl stearate, nylon-12, saccharide isomerate, ascorbyl

palmitate, BHT, tocopherol, lauroyl lysine, lecithin, disodium EDTA, citric acid, parfum [fragrance], hexyl cinnamal, hydroxyisohexyl 3-cyclohexene carboxaldehyde, butylphenyl methylpropional, alpha-isomethylionone, benzyl salicylate, citronellol, linalool, limonene, benzyl benzoate, phenoxyethanol, methylparaben, propylparaben,butylparaben, ethylparaben, isobutylparaben, CI 77 492 [iron oxides], CI 77 491 [iron oxides], CI 77 499 [iron oxides]

Warning Section

WARNINGS SECTION

Avoid contact with eyes. Keep out of reach of children. For External use only. Does not replace the use of sun products in care of sun exposure

Ask Doctor Section

OTC - ASK DOCTOR SECTION

Discontinue use and consult a doctor if signs of rash or irritation develops and persists

Direction:

INSTRUCTIONS FOR USE SECTION

Apply evenly onto cleansed skin in the morning. Ideal foundation for make-up

Principal Display

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Packaging

Principal Display Product Tube

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tube Packaging

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
24653-011-02	2019-11-27	C162847	48780-1	9855d018-ddfc-cd31-e053-dbdaa90ab51a	Optimal Tinted Complexion Cream

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
24653-011	OPTIMAL TINTED COMPLEXION (ETHYLHEXL METHOXYCINNAMATE) CREAM [JANSSEN COSMETICS GMBH]	4	Legacy NDC	20121002_fce481ed-94ef-4c80-a029-b6885d5c5092.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	4
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	4
.ALPHA.-HEXYLCINNAMALDEHYDE	INACTIVE INGREDIENT	7X6O37OK2I	4
.BETA.-CITRONELLOL, (R)-	INACTIVE INGREDIENT	P01OUT964K	4
ASCORBYL PALMITATE	INACTIVE INGREDIENT	QN83US2B0N	4
BENZYL BENZOATE	INACTIVE INGREDIENT	N863NB338G	4
BENZYL SALICYLATE	INACTIVE INGREDIENT	WAO5MNK9TU	4
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	4
BUTYLENE GLYCOL	INACTIVE INGREDIENT	3XUS85K0RA	4
BUTYLPARABEN	INACTIVE INGREDIENT	3QPI1U3FV8	4
BUTYLPHENYL METHYLPROPIONAL	INACTIVE INGREDIENT	T7540GJV69	4
C12-15 ALKYL BENZOATE	INACTIVE INGREDIENT	A9EJ3J61HQ	4
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE	INACTIVE INGREDIENT	FJ1H6M2JG9	4
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	4
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	4
DICAPRYLYL CARBONATE	INACTIVE INGREDIENT	609A3V1SUA	4
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	4
EGG PHOSPHOLIPIDS	INACTIVE INGREDIENT	1Z74184RGV	4
ETHYLPARABEN	INACTIVE INGREDIENT	14255EXE39	4
GLUCAMETACIN	INACTIVE INGREDIENT	N1EXE5EHAN	4
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	4
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE	INACTIVE INGREDIENT	QUE43B9Z2Q	4
ISOBUTYLPARABEN	INACTIVE INGREDIENT	0QQJ25X58G	4
ISOMETHYL-.ALPHA.-IONONE	INACTIVE INGREDIENT	9XP4LC555B	4
LAUROYL LYSINE	INACTIVE INGREDIENT	113171Q70B	4
LINALOOL, (+/-)-	INACTIVE INGREDIENT	D81QY6I88E	4
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	4
NYLON-12	INACTIVE INGREDIENT	446U8J075B	4
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	4
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	4
SACCHARIDE ISOMERATE	INACTIVE INGREDIENT	W8K377W98I	4
TOCOPHEROL	INACTIVE INGREDIENT	R0ZB2556P8	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	4

Products#

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

DailyMed product names page 1 of 1 · 34 matching rows.

Optimal Tinted Complexion
ethylhexl methoxycinnamate
OCTINOXATE
WATER
BUTYLENE GLYCOL
DICAPRYLYL CARBONATE
C12-15 ALKYL BENZOATE
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE
CETOSTEARYL ALCOHOL
GLUCAMETACIN
GLYCERYL MONOSTEARATE
NYLON-12
SACCHARIDE ISOMERATE
LAUROYL LYSINE
EGG PHOSPHOLIPIDS
ASCORBYL PALMITATE
BUTYLATED HYDROXYTOLUENE
TOCOPHEROL
EDETATE DISODIUM
CITRIC ACID MONOHYDRATE
.ALPHA.-HEXYLCINNAMALDEHYDE
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE
BUTYLPHENYL METHYLPROPIONAL
ISOMETHYL-.ALPHA.-IONONE
BENZYL SALICYLATE
.BETA.-CITRONELLOL, (R)-
LINALOOL, (+/-)-
BENZYL BENZOATE
PHENOXYETHANOL
METHYLPARABEN
PROPYLPARABEN
BUTYLPARABEN
ETHYLPARABEN
ISOBUTYLPARABEN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
24653-011	24653-011-01, 24653-011-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 32 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
OCTINOXATE	4Y5P7MUD51	ACTIB
WATER	059QF0KO0R	IACT
BUTYLENE GLYCOL	3XUS85K0RA	IACT
DICAPRYLYL CARBONATE	609A3V1SUA	IACT
C12-15 ALKYL BENZOATE	A9EJ3J61HQ	IACT
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE	FJ1H6M2JG9	IACT
CETOSTEARYL ALCOHOL	2DMT128M1S	IACT
GLUCAMETACIN	N1EXE5EHAN	IACT
GLYCERYL MONOSTEARATE	230OU9XXE4	IACT
NYLON-12	446U8J075B	IACT
SACCHARIDE ISOMERATE	W8K377W98I	IACT
LAUROYL LYSINE	113171Q70B	IACT
EGG PHOSPHOLIPIDS	1Z74184RGV	IACT
ASCORBYL PALMITATE	QN83US2B0N	IACT
BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	IACT
TOCOPHEROL	R0ZB2556P8	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
.ALPHA.-HEXYLCINNAMALDEHYDE	7X6O37OK2I	IACT
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE	QUE43B9Z2Q	IACT
BUTYLPHENYL METHYLPROPIONAL	T7540GJV69	IACT
ISOMETHYL-.ALPHA.-IONONE	9XP4LC555B	IACT
BENZYL SALICYLATE	WAO5MNK9TU	IACT
.BETA.-CITRONELLOL, (R)-	P01OUT964K	IACT
LINALOOL, (+/-)-	D81QY6I88E	IACT
BENZYL BENZOATE	N863NB338G	IACT
PHENOXYETHANOL	HIE492ZZ3T	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
BUTYLPARABEN	3QPI1U3FV8	IACT
ETHYLPARABEN	14255EXE39	IACT
ISOBUTYLPARABEN	0QQJ25X58G	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 8 · 421 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / INTRAMUSCULAR	0.13 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / INTRA-ARTICULAR	0.24 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, SOLUTION / INTRA-ARTICULAR	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION, CONCENTRATE / INTRAVENOUS	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, SUSPENSION / INTRAMUSCULAR		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, FILM COATED / ORAL	4 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, SUSPENSION / INTRA-ARTICULAR		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	OINTMENT / TOPICAL		1 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION, CONCENTRATE / ORAL	0.2 mg/1ml		Exact identifier — unii candidate 68 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SUSPENSION / ORAL		269 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	FILM, EXTENDED RELEASE / TRANSDERMAL	1.38 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	CAPSULE, EXTENDED RELEASE / ORAL	0.22 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	FILM, SOLUBLE / BUCCAL		1 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
TOCOPHEROL	TOCOPHEROL	R0ZB2556P8	CAPSULE / ORAL	NA		Exact identifier — unii candidate 5 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	TABLET, CHEWABLE / ORAL	1.28 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	CREAM / VAGINAL	0.49 %w/w		Exact identifier — unii candidate 88 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, ORALLY DISINTEGRATING / ORAL		3 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	LIQUID / RESPIRATORY (INHALATION)	0.13 %w/w		Exact identifier — unii candidate 88 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	TABLET, EXTENDED RELEASE / ORAL	0.12 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	TABLET, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	POWDER, FOR SOLUTION / TOPICAL	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	POWDER, FOR SOLUTION / ORAL		13 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / NASAL	250 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SHAMPOO, SUSPENSION / TOPICAL	0.25 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	AEROSOL, FOAM / TOPICAL	0.04 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
ASCORBYL PALMITATE	ASCORBYL PALMITATE	QN83US2B0N	CREAM / TOPICAL	0.02 %w/w		Exact identifier — unii candidate 6 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / INTRAMUSCULAR	0.05 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRABURSAL	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	CREAM / TOPICAL		836 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRACARDIAC		2 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	EMULSION / ORAL	NA		Exact identifier — unii candidate 21 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION/ DROPS / OPHTHALMIC	0.05 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / AURICULAR (OTIC)	0.2 %w/v		Exact identifier — unii candidate 88 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	AEROSOL, FOAM / TOPICAL	0.05 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	CREAM / VAGINAL		3 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INTRALESIONAL	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	CREAM / VAGINAL		140 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	FILM / BUCCAL	0.22 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / TOPICAL		216 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / SUBCUTANEOUS	0.16 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	DROPS / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 9 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SOLUTION / INTRAMUSCULAR		5 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION/ DROPS / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / RECTAL		97 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SHAMPOO, SUSPENSION / TOPICAL	0.15 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION, EXTENDED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION/ DROPS / AURICULAR (OTIC)	0.04 %w/w		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	LIQUID / ORAL		114 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
EGG PHOSPHOLIPIDS	EGG PHOSPHOLIPIDS	1Z74184RGV	EMULSION / INTRAVENOUS	1.2 %w/v		Exact identifier — unii candidate 5 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	0.8 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / RECTAL	0.13 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / ORAL		346 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SYRUP / ORAL	722 mg/5ml		Exact identifier — unii candidate 88 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SYSTEM / TOPICAL		21 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	LOTION / TOPICAL		1000 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRABURSAL	0.01 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / INTRAVENOUS	0.02 %w/v		Exact identifier — unii candidate 68 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
77ae783e-cda1-4c8b-9c25-d3d3a9fd8a3a			fce481ed-94ef-4c80-a029-b6885d5c5092	2012-09-20	Warnings	Exact identifier spl id: 77ae783e-cda1-4c8b-9c25-d3d3a9fd8a3a spl set id: fce481ed-94ef-4c80-a029-b6885d5c5092

Reported adverse events (FAERS/openFDA)#

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