Tinted Moisturizer

Manufacturer: Femme Couture International, Inc | Nuworld Corporation | Nu-World Corporation
Effective date: 2011-06-03
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:29:53

Label at a glance#

ProductTinted Moisturizer SPF-15

Active ingredientOctinoxate, Octisalate, Titanium Dioxide

Label structure4 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 6%
Octisalate 4%
Titanium Dioxide 3%

OTC - PURPOSE SECTION

Sunscreen

WARNINGS SECTION

For external use only
Do not use on damaged or broken skin
When using this product keep out of eyes. Rinse with water to remove.
Stop use and ask a doctor if rash occurs
Keep out of reach of children. If product is swallowed, get medical help or
contact a Poison Control Center right away.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

a21b2c1b-2116-4fd6-b254-29f4bf1ec23f

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
76351-100-01	2019-10-29	C162847	48780-1	960f7f55-d4ff-8e05-e053-dbdaa90a074a	2ece9e34-4ca1-41d5-9c48-306ba9388643

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76351-100-01	Tinted Moisturizer SPF-15	51.03 g in 1 TUBE	CREAM	51.03		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76351-100	TINTED MOISTURIZER (OCTINOXATE, OCTISALATE AND TITANIUM DIOXIDE) CREAM [FEMME COUTURE INTERNATIONAL, INC]	1	Legacy NDC, 1 package rows	20111026_2ece9e34-4ca1-41d5-9c48-306ba9388643.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Octinoxate	ACTIVE INGREDIENT	4Y5P7MUD51	1
Octisalate	ACTIVE INGREDIENT	4X49Y0596W	1
Titanium Dioxide	ACTIVE INGREDIENT	15FIX9V2JP	1
Octinoxate	ACTIVE MOIETY	4Y5P7MUD51	1
Octisalate	ACTIVE MOIETY	4X49Y0596W	1
Titanium Dioxide	ACTIVE MOIETY	15FIX9V2JP	1
.ALPHA.-TOCOPHEROL ACETATE, D-	INACTIVE INGREDIENT	A7E6112E4N	1
Brown Iron Oxide	INACTIVE INGREDIENT	1N032N7MFO	1
Caprylyl Glycol	INACTIVE INGREDIENT	00YIU5438U	1
Carbomer 934	INACTIVE INGREDIENT	Z135WT9208	1
Cetostearyl Alcohol	INACTIVE INGREDIENT	2DMT128M1S	1
Dimethicone	INACTIVE INGREDIENT	92RU3N3Y1O	1
EDETATE TRISODIUM	INACTIVE INGREDIENT	420IP921MB	1
Ferric Oxide Red	INACTIVE INGREDIENT	1K09F3G675	1
Ferric Oxide Yellow	INACTIVE INGREDIENT	EX438O2MRT	1
Ferrosoferric Oxide	INACTIVE INGREDIENT	XM0M87F357	1
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	1
Hexyl Laurate	INACTIVE INGREDIENT	4CG9F9W01Q	1
HYALURONATE SODIUM	INACTIVE INGREDIENT	YSE9PPT4TH	1
HYDROGENATED POLYBUTENE (370 MW)	INACTIVE INGREDIENT	V5H8103878	1
Magnesium Aluminum Silicate	INACTIVE INGREDIENT	6M3P64V0NC	1
Mica	INACTIVE INGREDIENT	V8A1AW0880	1
Phenoxyethanol	INACTIVE INGREDIENT	HIE492ZZ3T	1
Polyglyceryl-4 Isostearate	INACTIVE INGREDIENT	820DPX33S7	1
SIMMONDSIA CHINENSIS SEED WAX	INACTIVE INGREDIENT	47X6Y9FJJ2	1
SODIUM STEAROYL LACTYLATE	INACTIVE INGREDIENT	IN99IT31LN	1
Sorbic Acid	INACTIVE INGREDIENT	X045WJ989B	1
Squalane	INACTIVE INGREDIENT	GW89575KF9	1
Titanium Dioxide	INACTIVE INGREDIENT	15FIX9V2JP	1
Trolamine	INACTIVE INGREDIENT	9O3K93S3TK	1
Water	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

Tinted Moisturizer SPF-15
Octinoxate, Octisalate and Titanium Dioxide
Octinoxate
Octisalate
Water
Carbomer 934
EDETATE TRISODIUM
Glycerin
Magnesium Aluminum Silicate
Dimethicone
Cetostearyl Alcohol
Phenoxyethanol
Sorbic Acid
Caprylyl Glycol
Polyglyceryl-4 Isostearate
HYDROGENATED POLYBUTENE (370 MW)
Hexyl Laurate
SIMMONDSIA CHINENSIS SEED WAX
Squalane
.ALPHA.-TOCOPHEROL ACETATE, D-
SODIUM STEAROYL LACTYLATE
Trolamine
HYALURONATE SODIUM
Mica
Ferric Oxide Yellow
Ferric Oxide Red
Ferrosoferric Oxide
Brown Iron Oxide
Titanium Dioxide

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
76351-100	76351-100-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Octinoxate	4Y5P7MUD51	ACTIB
Octisalate	4X49Y0596W	ACTIB
Water	059QF0KO0R	IACT
Carbomer 934	Z135WT9208	IACT
EDETATE TRISODIUM	420IP921MB	IACT
Glycerin	PDC6A3C0OX	IACT
Magnesium Aluminum Silicate	6M3P64V0NC	IACT
Dimethicone	92RU3N3Y1O	IACT
Dimethicone	92RU3N3Y1O	IACT
Cetostearyl Alcohol	2DMT128M1S	IACT
Phenoxyethanol	HIE492ZZ3T	IACT
Sorbic Acid	X045WJ989B	IACT
Caprylyl Glycol	00YIU5438U	IACT
Polyglyceryl-4 Isostearate	820DPX33S7	IACT
Dimethicone	92RU3N3Y1O	IACT
HYDROGENATED POLYBUTENE (370 MW)	V5H8103878	IACT
Hexyl Laurate	4CG9F9W01Q	IACT
SIMMONDSIA CHINENSIS SEED WAX	47X6Y9FJJ2	IACT
Squalane	GW89575KF9	IACT
.ALPHA.-TOCOPHEROL ACETATE, D-	A7E6112E4N	IACT
SODIUM STEAROYL LACTYLATE	IN99IT31LN	IACT
Trolamine	9O3K93S3TK	IACT
HYALURONATE SODIUM	YSE9PPT4TH	IACT
Mica	V8A1AW0880	IACT
Ferric Oxide Yellow	EX438O2MRT	IACT
Ferric Oxide Red	1K09F3G675	IACT
Ferrosoferric Oxide	XM0M87F357	IACT
Brown Iron Oxide	1N032N7MFO	IACT
Titanium Dioxide	15FIX9V2JP	IACT
Titanium Dioxide	15FIX9V2JP	ACTIB

Source Document#

Source XML · Source PDF

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 5 · 267 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	SOAP / TOPICAL	1 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
Squalane	SQUALANE	GW89575KF9	CREAM, AUGMENTED / TOPICAL		120 mg	Exact identifier — unii candidate 5 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SHAMPOO / TOPICAL	5 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	PASTE / DENTAL	0.5 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION / AURICULAR (OTIC)	63.64 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	FILM, SOLUBLE / BUCCAL		11 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
Magnesium Aluminum Silicate	MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	CREAM / TOPICAL	3 %w/w		Exact identifier — unii candidate 17 equally ranked IID candidates
Ferric Oxide Yellow	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET, ORALLY DISINTEGRATING / ORAL		2 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SUSPENSION, EXTENDED RELEASE / ORAL		2000 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Ferric Oxide Yellow	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
Squalane	SQUALANE	GW89575KF9	AEROSOL, FOAM / TOPICAL	2.23 %w/w		Exact identifier — unii candidate 5 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / INTRAMUSCULAR	15 %w/v		Exact identifier — unii candidate 75 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
Carbomer 934	CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)	Z135WT9208	OINTMENT / TOPICAL	0.5 %w/w		Exact identifier — unii candidate 14 equally ranked IID candidates
HYALURONATE SODIUM	HYALURONATE SODIUM	YSE9PPT4TH	LOTION / TOPICAL	0.01 %w/w		Exact identifier — unii candidate 5 equally ranked IID candidates
Sorbic Acid	SORBIC ACID	X045WJ989B	SOLUTION / OPHTHALMIC	0.2 %w/v		Exact identifier — unii candidate 19 equally ranked IID candidates
Magnesium Aluminum Silicate	MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	LOTION / TOPICAL	1.5 %w/w		Exact identifier — unii candidate 17 equally ranked IID candidates
Magnesium Aluminum Silicate	MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	GRANULE, FOR SUSPENSION / ORAL	12.5 mg/5ml		Exact identifier — unii candidate 17 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	GEL / OPHTHALMIC	0.88 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SUSPENSION / AURICULAR (OTIC)	0.05 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	ELIXIR / ORAL		5621 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Phenoxyethanol	PHENOXYETHANOL	HIE492ZZ3T	CREAM / TOPICAL		57 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
Sorbic Acid	SORBIC ACID	X045WJ989B	TABLET, DELAYED RELEASE / ORAL	0.03 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
Cetostearyl Alcohol	CETOSTEARYL ALCOHOL	2DMT128M1S	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 9 equally ranked IID candidates
Sorbic Acid	SORBIC ACID	X045WJ989B	TABLET / SUBLINGUAL	0.16 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	INJECTION / SUBCUTANEOUS		450 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	FILM, EXTENDED RELEASE / TRANSDERMAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	CONCENTRATE / ORAL		1800 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION / RESPIRATORY (INHALATION)	5 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SUPPOSITORY / RECTAL		440 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Ferric Oxide Red	FERRIC OXIDE RED	1K09F3G675	TABLET, COATED / ORAL	1 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, EXTENDED RELEASE / ORAL		67 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION/ DROPS / OPHTHALMIC		12 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Magnesium Aluminum Silicate	MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	SUSPENSION / ORAL	5000 mg/5ml		Exact identifier — unii candidate 17 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	CLOTH / TOPICAL	0.05 mg/mg		Exact identifier — unii candidate 75 equally ranked IID candidates
Phenoxyethanol	PHENOXYETHANOL	HIE492ZZ3T	LOTION / TOPICAL	1 %w/w		Exact identifier — unii candidate 6 equally ranked IID candidates
Ferric Oxide Red	FERRIC OXIDE RED	1K09F3G675	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	3.6 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
Sorbic Acid	SORBIC ACID	X045WJ989B	AEROSOL, FOAM / TOPICAL		6 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
Ferric Oxide Red	FERRIC OXIDE RED	1K09F3G675	CAPSULE, COATED / ORAL	0.12 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET / ORAL		232 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
Trolamine	TROLAMINE	9O3K93S3TK	POWDER / TOPICAL	0.02 mg/mg		Exact identifier — unii candidate 22 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	TABLET, COATED / ORAL	1 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
Ferric Oxide Red	FERRIC OXIDE RED	1K09F3G675	CAPSULE / ORAL		5 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	POWDER / ORAL	2 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
Cetostearyl Alcohol	CETOSTEARYL ALCOHOL	2DMT128M1S	CREAM / TOPICAL		1428 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
Ferric Oxide Red	FERRIC OXIDE RED	1K09F3G675	CAPSULE, EXTENDED RELEASE / ORAL		5 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SYSTEM / IONTOPHORESIS	168.1 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
Ferric Oxide Yellow	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET, COATED / ORAL		1 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	GEL / TRANSDERMAL		500 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
HYALURONATE SODIUM	HYALURONATE SODIUM	YSE9PPT4TH	GEL / TOPICAL		463 mg	Exact identifier — unii candidate 5 equally ranked IID candidates
Brown Iron Oxide	BROWN IRON OXIDE	1N032N7MFO	CAPSULE / ORAL	NA		Exact identifier — unii candidate 3 equally ranked IID candidates
Magnesium Aluminum Silicate	MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	SHAMPOO / TOPICAL	1.25 %w/w		Exact identifier — unii candidate 17 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	LIQUID / ORAL		2400 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Ferric Oxide Red	FERRIC OXIDE RED	1K09F3G675	TABLET, CHEWABLE / ORAL		2 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
Squalane	SQUALANE	GW89575KF9	POWDER / ORAL	0.02 mg		Exact identifier — unii candidate 5 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, EXTENDED RELEASE / ORAL		90 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
Trolamine	TROLAMINE	9O3K93S3TK	LOTION / TOPICAL		360 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
Carbomer 934	CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)	Z135WT9208	TABLET, ORALLY DISINTEGRATING / ORAL		1 mg	Exact identifier — unii candidate 14 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	DROPS / ORAL	300 mg/1ml		Exact identifier — unii candidate 75 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
9fcf3934-4860-4dcb-99a4-bbcc5ae2c9ee			2ece9e34-4ca1-41d5-9c48-306ba9388643	2011-06-03	Warnings	Exact identifier spl id: 9fcf3934-4860-4dcb-99a4-bbcc5ae2c9ee spl set id: 2ece9e34-4ca1-41d5-9c48-306ba9388643

Reported adverse events (FAERS/openFDA)#

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