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 22:26:40

Label at a glance#

ProductSPF 15 Medium

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 top 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 (CI77019), Bismuth Oxichloride (CI 77163), Nylon-12, C12-15 Alkyl Benzoate, Phenoxyethanol, Kaolin, Silica Dimethyl Silylate, Ascorbyl Palmitate, Chlorphensin, Potassium Sorbate, Retinyl 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 Silylate (and) Atelocollagen (and) Lysine HCI (and) Glycine (and) Sodium Chondrotin Sulfate (and) Ornithine HCI, Zinc Oxide, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, 2, 9)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of label

OTC - ACTIVE INGREDIENT SECTION

Active ingredients Purpose

Titanium Dioxide.............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
54473-176-01	2019-10-29	C162847	48780-1	960f7f55-cd52-8e05-e053-dbdaa90a074a	Label of Mineral Foundation Medium

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54473-176-01	SPF 15Medium	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
54473-176	SPF 15 MEDIUM (TITANIUM DIOXIDE) POWDER [MELALEUCA, INC.]	3	Legacy NDC, 1 package rows	20101215_935a09ac-7523-4260-a50c-281dc74b7eaa.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 Medium
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
54473-176	54473-176-01

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
GLYCINE	GLYCINE	TE7660XO1C	INJECTION / INTRAMUSCULAR		68 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, COATED / ORAL		3 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET / BUCCAL		1 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	PASTE / ORAL		48 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SPRAY, METERED / NASAL		13 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	CAPSULE, COATED / ORAL	0.01 mg		Exact identifier — unii candidate 20 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	CREAM / TOPICAL	0.25 %w/w		Exact identifier — unii candidate 19 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER / ORAL		602 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CREAM / VAGINAL		51 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
GLYCINE	GLYCINE	TE7660XO1C	TABLET, ORALLY DISINTEGRATING / ORAL		60 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER, FOR SOLUTION / ORAL		280 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	GRANULE, FOR SUSPENSION / ORAL		80 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / RESPIRATORY (INHALATION)	5 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	SOLUTION / ORAL	1000 mg/15ml		Exact identifier — unii candidate 19 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SOAP / TOPICAL	1 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
UREA	UREA	8W8T17847W	TABLET, COATED / ORAL	0.02 mg		Exact identifier — unii candidate 7 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION/ DROPS / OPHTHALMIC		12 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	DROPS / ORAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
ASCORBYL PALMITATE	ASCORBYL PALMITATE	QN83US2B0N	TABLET / ORAL	7.14 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
TRIACETIN	TRIACETIN	XHX3C3X673	SUSPENSION / ORAL		7 mg	Exact identifier — unii candidate 14 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	AEROSOL / TOPICAL	3 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE / ORAL	5000 mg		Exact identifier — unii candidate 49 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
ZINC OXIDE	ZINC OXIDE	SOI2LOH54Z	SUPPOSITORY / RECTAL	375 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / NASAL		20 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
GLYCINE	GLYCINE	TE7660XO1C	TABLET / ORAL	163.31 mg		Exact identifier — unii candidate 20 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	JELLY / TOPICAL	NA		Exact identifier — unii candidate 75 equally ranked IID candidates
TRIACETIN	TRIACETIN	XHX3C3X673	CAPSULE, DELAYED RELEASE / ORAL	5.1 mg		Exact identifier — unii candidate 14 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE, FOR SOLUTION / ORAL	1.8 mg/120ml		Exact identifier — unii candidate 49 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	DOUCHE / VAGINAL	1 %w/w		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
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION / INTRADERMAL	1.6 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	PASTE, DENTIFRICE / DENTAL	0.4 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SHAMPOO, SUSPENSION / TOPICAL	3 %w/v		Exact identifier — unii candidate 40 equally ranked IID candidates
GLYCINE	GLYCINE	TE7660XO1C	INJECTION, SOLUTION / INTRAVENOUS	0.42 %w/v		Exact identifier — unii candidate 20 equally ranked IID candidates
ASCORBYL PALMITATE	ASCORBYL PALMITATE	QN83US2B0N	SYSTEM / TOPICAL	0.04 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SYSTEM / TRANSDERMAL		35 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
GLYCINE	GLYCINE	TE7660XO1C	INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS	0.5 mg		Exact identifier — unii candidate 20 equally ranked IID candidates
GLYCINE	GLYCINE	TE7660XO1C	SOLUTION / ORAL	50 mg		Exact identifier — unii candidate 20 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		336 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	CAPSULE, EXTENDED RELEASE / ORAL		7 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
TRIACETIN	TRIACETIN	XHX3C3X673	TABLET, COATED / ORAL	1 mg		Exact identifier — unii candidate 14 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
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / ORAL		750 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SPONGE / TOPICAL	2 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	CAPSULE, EXTENDED RELEASE / ORAL	1.49 mg		Exact identifier — unii candidate 10 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	GRANULE, FOR SUSPENSION / ORAL		143 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CLOTH / TOPICAL	0.05 mg/mg		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
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, DELAYED RELEASE / ORAL		66 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	FILM / BUCCAL	0.27 mg		Exact identifier — unii candidate 20 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION/ DROPS / OPHTHALMIC	2.5 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
TRIACETIN	TRIACETIN	XHX3C3X673	TABLET / ORAL		208 mg	Exact identifier — unii candidate 14 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CREAM / TOPICAL		1720 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCINE	GLYCINE	TE7660XO1C	PASTE, DENTIFRICE / DENTAL	0.34 %w/w		Exact identifier — unii candidate 20 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	LOTION / TOPICAL	1 %w/w		Exact identifier — unii candidate 6 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
TRIACETIN	TRIACETIN	XHX3C3X673	TABLET, EXTENDED RELEASE / ORAL		26 mg	Exact identifier — unii candidate 14 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	CONCENTRATE / ORAL		1 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, EXTENDED RELEASE / ORAL		450 mg	Exact identifier — unii candidate 49 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
b3c10e1a-4d87-45e1-8e8e-90fed0f8657e			935a09ac-7523-4260-a50c-281dc74b7eaa	2010-12-14		Exact identifier spl id: b3c10e1a-4d87-45e1-8e8e-90fed0f8657e spl set id: 935a09ac-7523-4260-a50c-281dc74b7eaa

Reported adverse events (FAERS/openFDA)#

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