FDA.reportPublic FDA data

250404

Manufacturer
Elizabeth Arden, Inc | Intercos
Effective date
2013-08-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:36:39

Key Label Information#

Active Ingredients And Purpose

OTC - ACTIVE INGREDIENT

OCTINOXATE 4.00%..............Sunscreen TITANIUM DIOXIDE 1.26%....Sunscreen

OTC - PURPOSE

Provides SPF 15 sun protection.

Uses

INDICATIONS & USAGE

smooth onto face.

Warnings

WARNINGS

For external use only

OTC - DO NOT USE

Do not use on damaged or broken skin

Other Label Information

INACTIVE INGREDIENT

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).

Label Images#

250404-figure-1-250480-2-figure-1-250483-2-figure-1-250369-figure-1-249999_released
250404-figure-1-250480-2-figure-1-250483-2-figure-1-250369-figure-1-249999_released

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
67938-2011-12020-01-31C16284748780-19d75b9cf-e72c-f424-e053-dadaa90a57ce250404

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67938-2011-1FLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE GOLDEN NUDE1 in 1 BOXLOTION11
67938-2011-2FLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE GOLDEN NUDE1500 mg in 1 BOTTLELOTION15001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67938-2011FLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE GOLDEN NUDE (OCTINOXATE AND TITANIUM DIOXIDE) LOTION [ELIZABETH ARDEN, INC]1Legacy NDC, 2 package rows20130820_44c8bd53-e8fa-4e2d-bf9b-c23e2b820b33.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#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67938-201167938-2011-2, 67938-2011-1

Ingredients#

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

Complete SPL Sections#

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.

Source Document#

Source XML