FDA.reportPublic FDA data

250369

Manufacturer
Elizabeth Arden, Inc | Intercos
Effective date
2013-08-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:36:25

Label at a glance#

ProductFLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE LINEN
Active ingredientOCTINOXATE, TITANIUM DIOXIDE
Label structure11 sections

Label contents#

Full prescribing information#

DESCRIPTION

DESCRIPTION SECTION

Makeup that feels like your own skin, only better. Light, breathable formula smooths on seamlessly for a naturally luminous look that lasts all day. Minimizes the look of pores and imperfections immediately and over time with continued use. Hydro-pigment color technology, vitamins and antioxidants protect and perfect, so skin looks beautifully even-toned and flawless.

INDICATIONS & USAGE

INDICATIONS & USAGE SECTION

smooth onto face.

WARNINGS

WARNINGS SECTION

For external use only

OTC - ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

OCTINOXATE 4.00%..............Sunscreen

TITANIUM DIOXIDE 1.26%....Sunscreen

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

WATER/AQUA/EAU, ISOHEXADECANE, HEXYL LAURATE, MICA, GLYCERIN, POLYGLYCERYL-4 ISOSTEARATE, POTASSIUM CETYL PHOSPHATE, CETEARYL ALCOHOL, ASCORBYL PALMITATE, BETAINE, CARBOMER, GLYCERYL STEARATE, HYDROLYZED VEGETABLE PROTEIN, LECITHIN, MAGNESIUM ALUMINUM SILICATE, PEG-100 STEARATE, POLYGLYCERYL-10 MYRISTATE, SODIUM HYDROXIDE, TOCOPHERYL ACETATE, TREMELLA FUCIFORMIS SPOROCARP EXTRACT, CHLORPHENESIN, PHENOXYETHANOL, POTASSIUM SORBATE, SODIUM BENZOATE, SODIUM DEHYDROACETATE [MAY CONTAIN/PEUT CONTENIR (+/-) IRON OXIDES (CI 77491, CI 77492, CI 77499), TITANIUM DIOXIDE (CI 77891).

OTC - DO NOT USE

OTC - DO NOT USE SECTION

Do not

use on damaged or broken skin

OTC - KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OTC - PURPOSE

OTC - PURPOSE SECTION

Provides SPF 15 sun protection.

OTC - STOP USE

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

OTC - WHEN USING

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FLAWLESS FINISH PERFECTLY NUDE MAKEUP SPF 15
FLAWLESS FINISH PERFECTLY NUDE MAKEUP SPF 15

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1c9d1af-bddd-448d-86f7-69052b7d5b47Product name120220627

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67938-2005-12020-01-31C16284748780-19d75b9d0-eefc-f424-e053-dadaa90a57ce250369

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67938-2005-1FLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE LINEN1 in 1 BOXLOTION11
67938-2005-2FLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE LINEN1500 mg in 1 BOTTLELOTION15001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67938-2005FLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE LINEN (OCTINOXATE AND TITANIUM DIOXIDE) LOTION [ELIZABETH ARDEN, INC]1Legacy NDC, 2 package rows20130802_bb561be7-6570-418a-b080-cb2ff9219c5b.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD511
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JP1
OCTINOXATEACTIVE MOIETY4Y5P7MUD511
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JP1
ASCORBYL PALMITATEINACTIVE INGREDIENTQN83US2B0N1
BETAINEINACTIVE INGREDIENT3SCV180C9W1
CHLORPHENESININACTIVE INGREDIENTI670DAL4SZ1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
HEXYL LAURATEINACTIVE INGREDIENT4CG9F9W01Q1
ISOHEXADECANEINACTIVE INGREDIENT918X1OUF1E1
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NC1
MICAINACTIVE INGREDIENTV8A1AW08801
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999R1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1
POLYGLYCERYL-4 ISOSTEARATEINACTIVE INGREDIENT820DPX33S71
POTASSIUM CETYL PHOSPHATEINACTIVE INGREDIENT03KCY6P7UT1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ41
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU1
SODIUM DEHYDROACETATEINACTIVE INGREDIENT8W46YN971G1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67938-200567938-2005-2, 67938-2005-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTINOXATE4Y5P7MUD51ACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB
WATER059QF0KO0RIACT
ISOHEXADECANE918X1OUF1EIACT
HEXYL LAURATE4CG9F9W01QIACT
MICAV8A1AW0880IACT
GLYCERINPDC6A3C0OXIACT
POLYGLYCERYL-4 ISOSTEARATE820DPX33S7IACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
ASCORBYL PALMITATEQN83US2B0NIACT
BETAINE3SCV180C9WIACT
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
PEG-100 STEARATEYD01N1999RIACT
SODIUM HYDROXIDE55X04QC32IIACT
CHLORPHENESINI670DAL4SZIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM DEHYDROACETATE8W46YN971GIACT

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 · 335 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ASCORBYL PALMITATEASCORBYL PALMITATEQN83US2B0NTABLET / ORAL7.14 mgExact identifier — unii candidate
6 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISUSPENSION/ DROPS / OPHTHALMICADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, EMULSION / INTRAVENOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTRAPLEURALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / AURICULAR (OTIC)25 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / EPIDURALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ICAPSULE, COATED / ORAL0.08 mgExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRADERMAL1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL / TOPICAL3 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRATHECALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTRAMUSCULAR176 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / INTRAVASCULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET, FILM COATED / ORAL1 mgExact identifier — unii candidate
35 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCLOTH / TOPICAL0.05 mg/mgExact identifier — unii candidate
75 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4TABLET, FILM COATED, EXTENDED RELEASE / ORAL0.2 mgExact identifier — unii candidate
19 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION/ DROPS / TOPICALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / EPIDURALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR27 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / IRRIGATIONADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTRACAVITARYADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SUSPENSION / SUBCUTANEOUS1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR5.4 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISUSPENSION, EXTENDED RELEASE / INTRADERMALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ITABLET, FILM COATED / ORAL8 mgExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IFILM / BUCCAL0.09 mgExact identifier — unii candidate
174 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCSHAMPOO / TOPICAL1.25 %w/wExact identifier — unii candidate
17 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ICREAM / VAGINAL0.19 %w/wExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, CHEWABLE / ORAL12 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IGEL / TRANSDERMAL472 mgExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGUM, CHEWING / BUCCAL230 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION/ DROPS / OPHTHALMICADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / BUCCAL34 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IAEROSOL, METERED / RESPIRATORY (INHALATION)ADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / SUBCUTANEOUS450 mgExact identifier — unii candidate
75 equally ranked IID candidates
ASCORBYL PALMITATEASCORBYL PALMITATEQN83US2B0NSYSTEM / TOPICAL0.04 mgExact identifier — unii candidate
6 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXEMULSION / OPHTHALMIC3 mgExact identifier — unii candidate
75 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4SOLUTION/ DROPS / OPHTHALMIC0.47 %w/vExact identifier — unii candidate
19 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4PASTE / ORAL48 mgExact identifier — unii candidate
19 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS136.55 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISPONGE / TOPICALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXJELLY / VAGINALNAExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUPASTE, DENTIFRICE / DENTAL0.5 %w/wExact identifier — unii candidate
35 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTRASPINALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUCAPSULE / ORAL8.5 mgExact identifier — unii candidate
35 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / OPHTHALMIC12 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ITABLET, EXTENDED RELEASE / ORAL13 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTRACARDIACADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ICREAM / TOPICAL69 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ILOTION / TOPICAL21 mgExact identifier — unii candidate
174 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii candidate
6 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / TOPICAL2.5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SUSPENSION / SOFT TISSUEADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
PEG-100 STEARATEPEG-100 MONOSTEARATEYD01N1999RLOTION / TOPICAL1 %w/wExact identifier — unii candidate
3 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IGRANULE, FOR SUSPENSION / ORALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCLIQUID / ORAL82 mg/5mlExact identifier — unii candidate
17 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCTABLET / ORAL60 mgExact identifier — unii candidate
17 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / PERIDURALADJ PHExact identifier — unii candidate
174 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
7fd98d21-94a0-44c2-8101-cd461bbfc17fbb561be7-6570-418a-b080-cb2ff9219c5b2013-08-02WarningsExact identifier
spl id: 7fd98d21-94a0-44c2-8101-cd461bbfc17f
spl set id: bb561be7-6570-418a-b080-cb2ff9219c5b

Reported adverse events (FAERS/openFDA)#

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