FLAWLESS SKIN TOTAL PROTECTION CONCEALER SPF 25

Manufacturer: PRESCRIPTIVES INC | ELGC K.K. | Estee Lauder Pennsylvania Distribution Center 2 (PADC 2) | Estee Lauder Inc. | ESTEE LAUDER COSMETICS DISTRIBUTION CENTER | ESTEE LAUDER COSMETICS, LTD | ESTEE LAUDER COSMETICS, LTD. | ESTEE LAUDER N.V. | LEN-RON MANUFACTURING DIVISION OF ARAMIS INC | NORTEC KEYSTONE | NORTHTEC BRISTOL | NORTHTEC KEYSTONE | WHITMAN LABORATORIES, LTD. | Aveda Corporation | Pennsylvania Logistics Center | Toshiki Pigment Company Limited
Effective date: 2012-09-11
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:33:03

Label at a glance#

ProductFLAWLESS SKIN TOTAL PROTECTION CONCEALER SPF 25

Active ingredientTITANIUM DIOXIDE

Label structure6 sections

Label contents#

Full prescribing information#

Usage

INDICATIONS & USAGE SECTION

Apply before sun exposure.

WARNING

WARNINGS SECTION

Keep out of eyes.

OTC - STOP USE SECTION

Stop use if irritation occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

TITANIUM DIOXIDE 4.20%

INGREDIENTS

INACTIVE INGREDIENT SECTION

ISOCETYL MYRISTATE • METHYL METHACRYLATE CROSSPOLYMER • DIISOSTEARYL MALATE • COPERNICIA CERIFERA (CARNAUBA) WAX\CERA CARNAUBA\CIRE DE CARNAUBA • POLYGLYCERYL-2 OLEATE • EUPHORBIA CERIFERA (CANDELILLA) WAX\CANDELILLA CERA\CIRE DE CANDELILLA • POLYETHYLENE • GLYCINE SOJA (SOYBEAN) OIL • TOCOPHERYL ACETATE • PORIA COCOS SCLEROTIUM EXTRACT • ISOPROPYL TITANIUM TRIISOSTEARATE • ROSMARINUS OFFICINALIS (ROSEMARY) EXTRACT • SODIUM RNA • PHYTOSPHINGOSINE • SANTALUM ALBUM SEED EXTRACT • HYDROGENATED COTTONSEED OIL • ALLYL METHACRYLATES CROSSPOLYMER • SILICA • DIMETHICONE • DIMETHICONE SILYLATE • ALUMINA • TIN OXIDE • BHT • [+/- MICA • TITANIUM DIOXIDE (CI 77891) • IRON OXIDES (CI 77491, CI 77492, CI 77499)] <ILN33642>

SPL UNCLASSIFIED SECTION

PRESCRIPTIVES CO., DIST.
NEW YORK, N.Y. 10022

PRINCIPAL DISPLAY PANEL - 3.5g Container Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PX
PRESCRIPTIVES

Flawless Skin

Total Protection Concealer
UVA/UVB SPF 25

Net Wt./Poids Net . 11 Oz. / 3.5g e

PRINCIPAL DISPLAY PANEL - 3.5g Container Carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
baf7f49c-75b6-496b-a00e-8e766a8e4f03	Product name	1	20210127
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210
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
59158-914-01	2020-01-31	C162847	48780-1	9d75b9d0-2e6f-f424-e053-dadaa90a57ce	FLAWLESS SKIN TOTAL PROTECTION CONCEALER SPF 25

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
59158-914-01	FLAWLESS SKIN TOTAL PROTECTION CONCEALER SPF 25	3.5 g in 1 CONTAINER	PASTE	3.5		1
59158-914-01	FLAWLESS SKIN TOTAL PROTECTION CONCEALER SPF 25	1 in 1 CARTON	PASTE	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59158-914	FLAWLESS SKIN TOTAL PROTECTION CONCEALER SPF 25 (TITANIUM DIOXIDE) PASTE [PRESCRIPTIVES INC]	1	Legacy NDC, 2 package rows	20120918_cc4e3809-cf43-457d-bea2-3ff474e2723b.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
TITANIUM DIOXIDE	ACTIVE INGREDIENT	15FIX9V2JP	1
TITANIUM DIOXIDE	ACTIVE MOIETY	15FIX9V2JP	1
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	1
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	1
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	1
CANDELILLA WAX	INACTIVE INGREDIENT	WL0328HX19	1
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	1
DIISOSTEARYL MALATE	INACTIVE INGREDIENT	QBS8A3XZGQ	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	1
HIGH DENSITY POLYETHYLENE	INACTIVE INGREDIENT	UG00KM4WR7	1
HYDROGENATED COTTONSEED OIL	INACTIVE INGREDIENT	Z82Y2C65EA	1
ISOCETYL MYRISTATE	INACTIVE INGREDIENT	69AX3BRR5N	1
ISOPROPYL TITANIUM TRIISOSTEARATE	INACTIVE INGREDIENT	949E3KBJ1I	1
MICA	INACTIVE INGREDIENT	V8A1AW0880	1
PHYTOSPHINGOSINE	INACTIVE INGREDIENT	GIN46U9Q2Q	1
ROSEMARY	INACTIVE INGREDIENT	IJ67X351P9	1
SANTALUM ALBUM SEED	INACTIVE INGREDIENT	7RZT0U509Y	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	1
SOYBEAN OIL	INACTIVE INGREDIENT	241ATL177A	1
STANNIC OXIDE	INACTIVE INGREDIENT	KM7N50LOS6	1

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

FLAWLESS SKIN TOTAL PROTECTION CONCEALER SPF 25
TITANIUM DIOXIDE
ISOCETYL MYRISTATE
DIISOSTEARYL MALATE
CARNAUBA WAX
CANDELILLA WAX
HIGH DENSITY POLYETHYLENE
SOYBEAN OIL
.ALPHA.-TOCOPHEROL ACETATE
ISOPROPYL TITANIUM TRIISOSTEARATE
ROSEMARY
PHYTOSPHINGOSINE
SANTALUM ALBUM SEED
HYDROGENATED COTTONSEED OIL
SILICON DIOXIDE
DIMETHICONE
ALUMINUM OXIDE
STANNIC OXIDE
BUTYLATED HYDROXYTOLUENE
MICA
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
59158-914	59158-914-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
TITANIUM DIOXIDE	15FIX9V2JP	ACTIB
ISOCETYL MYRISTATE	69AX3BRR5N	IACT
DIISOSTEARYL MALATE	QBS8A3XZGQ	IACT
CARNAUBA WAX	R12CBM0EIZ	IACT
CANDELILLA WAX	WL0328HX19	IACT
HIGH DENSITY POLYETHYLENE	UG00KM4WR7	IACT
SOYBEAN OIL	241ATL177A	IACT
.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	IACT
ISOPROPYL TITANIUM TRIISOSTEARATE	949E3KBJ1I	IACT
ROSEMARY	IJ67X351P9	IACT
PHYTOSPHINGOSINE	GIN46U9Q2Q	IACT
SANTALUM ALBUM SEED	7RZT0U509Y	IACT
HYDROGENATED COTTONSEED OIL	Z82Y2C65EA	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
DIMETHICONE	92RU3N3Y1O	IACT
ALUMINUM OXIDE	LMI26O6933	IACT
STANNIC OXIDE	KM7N50LOS6	IACT
BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	IACT
MICA	V8A1AW0880	IACT
FERRIC OXIDE RED	1K09F3G675	IACT
FERRIC OXIDE YELLOW	EX438O2MRT	IACT
FERROSOFERRIC OXIDE	XM0M87F357	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 4 · 184 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	TABLET, DELAYED RELEASE / ORAL		6 mg	Exact identifier — unii candidate 10 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
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TAMPON / VAGINAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	TABLET, COATED / ORAL	NA		Exact identifier — unii candidate 10 equally ranked IID candidates
HYDROGENATED COTTONSEED OIL	HYDROGENATED COTTONSEED OIL	Z82Y2C65EA	TABLET / ORAL		72 mg	Exact identifier — unii candidate 7 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 11 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE, FOR SUSPENSION / ORAL		200 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
HIGH DENSITY POLYETHYLENE	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	TABLET, EXTENDED RELEASE / ORAL	0.64 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / SUBLINGUAL		10 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
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	TABLET / ORAL		8 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
HIGH DENSITY POLYETHYLENE	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	JELLY / VAGINAL	42.6 %w/w		Exact identifier — unii candidate 18 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
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	TABLET, EXTENDED RELEASE / ORAL		8 mg	Exact identifier — unii candidate 10 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	TABLET / ORAL		3 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
HIGH DENSITY POLYETHYLENE	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	PASTE / TOPICAL	2.5 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
HIGH DENSITY POLYETHYLENE	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	SYSTEM / TRANSDERMAL	NA		Exact identifier — unii candidate 18 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 YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	POWDER, FOR SUSPENSION / ORAL		3 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	GUM, CHEWING / BUCCAL		5 mg	Exact identifier — unii candidate 32 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
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET, COATED / ORAL		1 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
HIGH DENSITY POLYETHYLENE	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
HIGH DENSITY POLYETHYLENE	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	TAPE / TOPICAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	INSERT / VAGINAL		8 mg	Exact identifier — unii candidate 49 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
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET, FILM COATED / ORAL		6 mg	Exact identifier — unii candidate 20 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
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
HIGH DENSITY POLYETHYLENE	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	TABLET / ORAL	50 mg		Exact identifier — unii candidate 18 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
CANDELILLA WAX	CANDELILLA WAX	WL0328HX19	TABLET / ORAL		4 mg	Exact identifier — unii candidate 4 equally ranked IID candidates
HYDROGENATED COTTONSEED OIL	HYDROGENATED COTTONSEED OIL	Z82Y2C65EA	CAPSULE, EXTENDED RELEASE / ORAL	58 mg		Exact identifier — unii candidate 7 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / DENTAL	19 %w/w		Exact identifier — unii candidate 49 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
HIGH DENSITY POLYETHYLENE	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	OINTMENT / TOPICAL	94 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
HIGH DENSITY POLYETHYLENE	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	TABLET, COATED / ORAL	25 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SHAMPOO / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 32 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	TABLET, EXTENDED RELEASE / ORAL		7 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FOR SUSPENSION / ORAL		220 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
CANDELILLA WAX	CANDELILLA WAX	WL0328HX19	TABLET, DELAYED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 4 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	GEL / TOPICAL		8 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 11 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	GUM, CHEWING / BUCCAL		10 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
CANDELILLA WAX	CANDELILLA WAX	WL0328HX19	TABLET, FILM COATED / ORAL	0.8 mg		Exact identifier — unii candidate 4 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	TABLET, EXTENDED RELEASE / ORAL		2150 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
SOYBEAN OIL	SOYBEAN OIL	241ATL177A	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	10 %w/v		Exact identifier — unii candidate 7 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	PELLET / ORAL		34 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	SUSPENSION, EXTENDED RELEASE / ORAL	2.7 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SUPPOSITORY / RECTAL		1 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
HIGH DENSITY POLYETHYLENE	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	OINTMENT / OPHTHALMIC	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
SOYBEAN OIL	SOYBEAN OIL	241ATL177A	INJECTION, EMULSION / INTRAVENOUS		107100 mg	Exact identifier — unii candidate 7 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	CAPSULE / ORAL	2 mg		Exact identifier — unii candidate 3 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	AEROSOL, FOAM / TOPICAL		4 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	TABLET, DELAYED RELEASE / ORAL	230 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET, DELAYED RELEASE / ORAL		7 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	DROPS / ORAL	NA		Exact identifier — unii candidate 21 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
ec997f74-4a04-4f65-b9fa-dc00edba452d			cc4e3809-cf43-457d-bea2-3ff474e2723b	2012-09-11	Warnings	Exact identifier spl id: ec997f74-4a04-4f65-b9fa-dc00edba452d spl set id: cc4e3809-cf43-457d-bea2-3ff474e2723b

Reported adverse events (FAERS/openFDA)#

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