SPF 15

Manufacturer: Melaleuca, Inc.
Effective date: 2010-12-14
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-05-31 22:26:39

Label at a glance#

ProductSPF 15 Fair

Active ingredientTITANIUM DIOXIDE

Label structure6 sections

Storage and handling

Other Information do not store at temperatures below 32°F (0°C) or above 120°F (49°C)

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

Directions

Apply evenly before sun exposure and as needed. Gently swirl your Sei Bella Brush across the tip and tap to remove excess.
Make sure powder is evenly distributed on brush before applying to face. Blend foundation to the desired level of coverage.

CLINICAL STUDIES SECTION

Other Information

dermatologist and allergy tested

STORAGE AND HANDLING SECTION

Other Information

do not store at temperatures below 32°F (0°C) or above 120°F (49°C)

INACTIVE INGREDIENT SECTION

Inactive ingredients

Mica (CI 77019), Bismuth Oxichloride (CI 77163), Nylon-12, C12-15 Alkyl Benzoate, Phenoxyethanol, Kaolin, Silica Dimethyl Silylate, Ascorbyl Palmitate, Chlorphensin, Potassium Sorbate, Retinly Palmitate, Lecithin, Hyaluronic Acid (and) Echinacin, Glycerin (and) Water (and) Urea (and) Trehalose (and) Polyquaternium-51 (and) Triacetin (and) Sodium Hyaluronate, Zinc PCA, Lauryl PCA, Dimethicone (and) Water (and) Silica Dimethyl Silicylate (and) Atelocollagen (and) Lysine HCI (and) Glycine (and) Sodium Chrondrotin Sulfate (and) Ornithine HCI, Zinc Oxide, Titanium Oxide (CI 778914), Iron Oxides (CI 77491, 2, 9)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of label

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient Purpose

Titanium Dioxide 7%.......Sunscreen

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
54473-174-01	2019-10-29	C162847	48780-1	960f7f55-d157-8e05-e053-dbdaa90a074a	Label of Mineral Foundation Fair

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54473-174-01	SPF 15Fair	10 g in 1 CONTAINER	POWDER	10		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54473-174	SPF 15 FAIR (TITANIUM DIOXIDE) POWDER [MELALEUCA, INC.]	3	Legacy NDC, 1 package rows	20101215_20c355ec-dbd0-4829-877d-64e83949e4ae.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
TITANIUM DIOXIDE	ACTIVE INGREDIENT	15FIX9V2JP	3
TITANIUM DIOXIDE	ACTIVE MOIETY	15FIX9V2JP	3
ALPHA-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	3
ASCORBYL PALMITATE	INACTIVE INGREDIENT	QN83US2B0N	3
BISMUTH OXYCHLORIDE	INACTIVE INGREDIENT	4ZR792I587	3
C12-15 ALKYL BENZOATE	INACTIVE INGREDIENT	A9EJ3J61HQ	3
CHLORPHENESIN	INACTIVE INGREDIENT	I670DAL4SZ	3
CHONDROITIN SULFATE (PORCINE)	INACTIVE INGREDIENT	V5E8ELO4W9	3
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	3
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	3
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	3
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	3
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	3
GLYCINE	INACTIVE INGREDIENT	TE7660XO1C	3
HYALURONATE SODIUM	INACTIVE INGREDIENT	YSE9PPT4TH	3
HYALURONIC ACID	INACTIVE INGREDIENT	S270N0TRQY	3
KAOLIN	INACTIVE INGREDIENT	24H4NWX5CO	3
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	3
LYSINE HYDROCHLORIDE	INACTIVE INGREDIENT	JNJ23Q2COM	3
MICA	INACTIVE INGREDIENT	V8A1AW0880	3
ORNITHINE HYDROCHLORIDE	INACTIVE INGREDIENT	HBK84K66XH	3
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	3
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	3
SODIUM PYRROLIDONE CARBOXYLATE	INACTIVE INGREDIENT	469OTG57A2	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	3
TREHALOSE	INACTIVE INGREDIENT	B8WCK70T7I	3
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	3
UREA	INACTIVE INGREDIENT	8W8T17847W	3
VITAMIN A PALMITATE	INACTIVE INGREDIENT	1D1K0N0VVC	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	3
ZINC OXIDE	INACTIVE INGREDIENT	SOI2LOH54Z	3
ZINC PIDOLATE	INACTIVE INGREDIENT	C32PQ86DH4	3

Products#

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

DailyMed product names page 1 of 1 · 32 matching rows.

SPF 15 Fair
TITANIUM DIOXIDE
MICA
BISMUTH OXYCHLORIDE
PHENOXYETHANOL
KAOLIN
ASCORBYL PALMITATE
CHLORPHENESIN
POTASSIUM SORBATE
VITAMIN A PALMITATE
LECITHIN, SOYBEAN
HYALURONIC ACID
GLYCERIN
WATER
UREA
TREHALOSE
TRIACETIN
DIMETHICONE
LYSINE HYDROCHLORIDE
GLYCINE
CHONDROITIN SULFATE (PORCINE)
ZINC OXIDE
ALPHA-TOCOPHEROL ACETATE
C12-15 ALKYL BENZOATE
SODIUM PYRROLIDONE CARBOXYLATE
HYALURONATE SODIUM
ORNITHINE HYDROCHLORIDE
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
FERROSOFERRIC OXIDE
ZINC PIDOLATE
SILICON DIOXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
54473-174	54473-174-01

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
TITANIUM DIOXIDE	15FIX9V2JP	ACTIB
MICA	V8A1AW0880	IACT
BISMUTH OXYCHLORIDE	4ZR792I587	IACT
PHENOXYETHANOL	HIE492ZZ3T	IACT
KAOLIN	24H4NWX5CO	IACT
ASCORBYL PALMITATE	QN83US2B0N	IACT
CHLORPHENESIN	I670DAL4SZ	IACT
POTASSIUM SORBATE	1VPU26JZZ4	IACT
VITAMIN A PALMITATE	1D1K0N0VVC	IACT
LECITHIN, SOYBEAN	1DI56QDM62	IACT
HYALURONIC ACID	S270N0TRQY	IACT
GLYCERIN	PDC6A3C0OX	IACT
WATER	059QF0KO0R	IACT
UREA	8W8T17847W	IACT
TREHALOSE	B8WCK70T7I	IACT
TRIACETIN	XHX3C3X673	IACT
DIMETHICONE	92RU3N3Y1O	IACT
LYSINE HYDROCHLORIDE	JNJ23Q2COM	IACT
GLYCINE	TE7660XO1C	IACT
CHONDROITIN SULFATE (PORCINE)	V5E8ELO4W9	IACT
ZINC OXIDE	SOI2LOH54Z	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
ALPHA-TOCOPHEROL ACETATE	9E8X80D2L0	IACT
C12-15 ALKYL BENZOATE	A9EJ3J61HQ	IACT
SODIUM PYRROLIDONE CARBOXYLATE	469OTG57A2	IACT
HYALURONATE SODIUM	YSE9PPT4TH	IACT
ORNITHINE HYDROCHLORIDE	HBK84K66XH	IACT
FERRIC OXIDE YELLOW	EX438O2MRT	IACT
FERRIC OXIDE RED	1K09F3G675	IACT
FERROSOFERRIC OXIDE	XM0M87F357	IACT
ZINC PIDOLATE	C32PQ86DH4	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	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 6 · 323 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
ZINC OXIDE	ZINC OXIDE	SOI2LOH54Z	INJECTION / SUBCUTANEOUS	0.02 %w/v		Exact identifier — unii candidate 6 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	FILM / BUCCAL		3 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
TRIACETIN	TRIACETIN	XHX3C3X673	TABLET, FILM COATED / ORAL	15.12 mg		Exact identifier — unii candidate 14 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
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION, EXTENDED RELEASE / ORAL		2000 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, COATED / ORAL		17 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE / ORAL		300 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	0.2 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	PASTE / DENTAL	34 %w/w		Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	FILM, EXTENDED RELEASE / TRANSDERMAL	49 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
TRIACETIN	TRIACETIN	XHX3C3X673	SYSTEM / TRANSDERMAL	22.1 mg		Exact identifier — unii candidate 14 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / NASAL	25 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
KAOLIN	KAOLIN	24H4NWX5CO	SYSTEM / TOPICAL		420 mg	Exact identifier — unii candidate 13 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SPONGE / TOPICAL	2 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, COATED / ORAL		3 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, CHEWABLE / ORAL		254 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
UREA	UREA	8W8T17847W	TABLET, EXTENDED RELEASE / ORAL	0.01 mg		Exact identifier — unii candidate 7 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	FILM, SOLUBLE / ORAL		2 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	GEL / OPHTHALMIC	0.88 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
TRIACETIN	TRIACETIN	XHX3C3X673	SUSPENSION, EXTENDED RELEASE / ORAL		4 mg	Exact identifier — unii candidate 14 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	CREAM / TOPICAL		57 mg	Exact identifier — unii candidate 6 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
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
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, LIQUID FILLED / ORAL		106 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SYSTEM / TOPICAL		420 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	225 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	CAPSULE, DELAYED RELEASE / ORAL		6 mg	Exact identifier — unii candidate 10 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / TOPICAL		1971 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / ORAL		750 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	AEROSOL, FOAM / TOPICAL		21 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, COATED PELLETS / ORAL	4.4 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE / ORAL		3487 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	TABLET / SUBLINGUAL	1 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	EMULSION / INTRAVENOUS	2.2 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 20 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE, FOR SUSPENSION / ORAL		200 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	POWDER, FOR SUSPENSION / ORAL	NA		Exact identifier — unii candidate 10 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	CAPSULE / ORAL		14 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	TABLET / ORAL		8 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
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	CAPSULE / ORAL		11 mg	Exact identifier — unii candidate 10 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	PASTE / DENTAL	20 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	CREAM, AUGMENTED / TOPICAL		10 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	FILM / BUCCAL	0.09 mg		Exact identifier — unii candidate 3 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	TABLET, FILM COATED / ORAL	0.2 mg		Exact identifier — unii candidate 10 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	POWDER, FOR SUSPENSION / ORAL		1 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	POWDER, FOR SUSPENSION / ORAL		3 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / DENTAL	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET, CHEWABLE / ORAL		14 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
GLYCINE	GLYCINE	TE7660XO1C	POWDER, FOR SUSPENSION / ORAL		400 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	TABLET, COATED / ORAL	NA		Exact identifier — unii candidate 10 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION/ DROPS / AURICULAR (OTIC)		25 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
KAOLIN	KAOLIN	24H4NWX5CO	POWDER, FOR SUSPENSION / ORAL	NA		Exact identifier — unii candidate 13 equally ranked IID candidates
TRIACETIN	TRIACETIN	XHX3C3X673	TABLET, EXTENDED RELEASE / ORAL		26 mg	Exact identifier — unii candidate 14 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / DENTAL	19 %w/w		Exact identifier — unii candidate 49 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	EMULSION / OPHTHALMIC		3 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	LOTION / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 19 equally ranked IID candidates
GLYCINE	GLYCINE	TE7660XO1C	INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS	0.5 mg		Exact identifier — unii candidate 20 equally ranked IID candidates
LECITHIN, SOYBEAN	SOYBEAN LECITHIN	1DI56QDM62	TABLET, FILM COATED / ORAL	0.33 mg		Exact identifier — unii candidate 7 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
22e7a4e4-595f-49e7-8380-ee3cce81200e			20c355ec-dbd0-4829-877d-64e83949e4ae	2010-12-14		Exact identifier spl id: 22e7a4e4-595f-49e7-8380-ee3cce81200e spl set id: 20c355ec-dbd0-4829-877d-64e83949e4ae

Reported adverse events (FAERS/openFDA)#

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