Intervene Makeup SPF 15 Soft Toffee

Manufacturer
Elizabeth Arden, Inc
Effective date
2011-01-13
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:28:50

Label at a glance#

ProductIntervene Makeup SPF 15 Soft Toffee
Active ingredientOCTINOXATE
Label structure10 sections

Indications and uses

To Use: Smooth on to face before sun exposure.

Label contents#

Full prescribing information#

DESCRIPTION

DESCRIPTION SECTION

For normal skin. Medium/full coverage. Soft natural finish. This innovative liquid makeup with Biodormin technology helps delay the appearance of new lines and wrinkles as it firms the look of skin. Micro-mineral pigment technology smoothes imperfections, evens out skin tone and creates a soft natural finish that lasts all day. Provides SPF 15 sun protection. Clinitcally, dermatologist, and allergy tested.

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

To Use: Smooth on to face before sun exposure.

WARNINGS

WARNINGS SECTION

Warning: For external use only. Keep out of eyes. Stop use and see a doctor if rash or irritation develops and lasts. Keep out of reach of children.

OTC - ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Octinoxate 5% w/w.

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Other Ingredients: Cyclopentasiloxane, Water/Aqua/Eau, Isododecane, Butylene Glycol, Ethylhexyl Methoxycinnamate, Talc, Mica, Polymethyl Methacrylate, Silica Silylate, Sorbitan Tristearate, PEG/PPG-18/18 Dimethicone, Silica, Trimethylsiloxysilicate, Palmitoyl Tetrapeptide-7, Narcissus Tazetta Bulb Extract, Trifolium Pratense (Clover) Flower Extract, Ascorbyl Plamitate, Tocopherol, Lecithin, Clycerin, Hydolyzed Soy Protein, Laureth-4, Laureth-7, Steareth-20, Disteardimonium Hectorite, Deimethicone/Vinyl Dimethicone Crosspolymer, Propylene Carbonate, BHT, Sodium Chloride, Dimethicone, Dimethiconol, Fragrance/Parfum, Butylparaben, Ethylparaben, Isobutylparaben, Methylparaben, Phenoxyethanol, Propylparaben, Sodium Dehydroacetate, Iron Oxides (CI 77491, CI 77492, CI 77499), Titanium Dioxide (CI77891).

DOSAGE & ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Smooth on to face.

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 - WHEN USING

OTC - WHEN USING SECTION

Keep out of eyes.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Intervene Makeup CartonIntervene Makeup Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67938-1088-12019-10-29C16284748780-1960f7f55-c10a-8e05-e053-dbdaa90a074aBC1088

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67938-1088-1Intervene Makeup SPF 15 Soft Toffee1 in 1 BOXCREAM13
67938-1088-2Intervene Makeup SPF 15 Soft Toffee30 mL in 1 BOTTLE, PUMPCREAM303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67938-1088INTERVENE MAKEUP SPF 15 SOFT TOFFEE (OCTINOXATE) CREAM [ELIZABETH ARDEN, INC]3Legacy NDC, 2 package rows20110722_97bc9457-aba6-4c0d-8873-5babd585a72d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD513
OCTINOXATEACTIVE MOIETY4Y5P7MUD513
ALPHA-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ13
ASCORBYL PALMITATEINACTIVE INGREDIENTQN83US2B0N3
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171K3
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA3
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV83
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O3
ETHYLPARABENINACTIVE INGREDIENT14255EXE393
GLYCERININACTIVE INGREDIENTPDC6A3C0OX3
ISOBUTYLPARABENINACTIVE INGREDIENT0QQJ25X58G3
ISODODECANEINACTIVE INGREDIENTA8289P68Y23
LAURETH-4INACTIVE INGREDIENT6HQ855798J3
LAURETH-7INACTIVE INGREDIENTZ95S6G82013
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T3
MICAINACTIVE INGREDIENTV8A1AW08803
NARCISSUS TAZETTA BULBINACTIVE INGREDIENTK17762966S3
PALMITOYL TETRAPEPTIDE-7INACTIVE INGREDIENTQ41S464P1R3
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T3
PROPYLENE CARBONATEINACTIVE INGREDIENT8D08K3S51E3
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU43
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8X3
SODIUM DEHYDROACETATEINACTIVE INGREDIENT8W46YN971G3
SORBITAN TRISTEARATEINACTIVE INGREDIENT6LUM6968113
STEARETH-20INACTIVE INGREDIENTL0Q8IK9E083
TALCINACTIVE INGREDIENT7SEV7J4R1U3
TRIFOLIUM PRATENSE FLOWERINACTIVE INGREDIENT4JS08388283
WATERINACTIVE INGREDIENT059QF0KO0R3

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67938-108867938-1088-2, 67938-1088-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

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 9 · 523 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KCAPSULE, EXTENDED RELEASE / ORAL0.03 mgExact identifier — unii candidate
32 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAVENOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / INTRAMUSCULAR95 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION, SUSPENSION / SUBCUTANEOUS0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, FILM COATED / ORAL1.55 mgExact identifier — unii candidate
75 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TPOWDER, FOR SUSPENSION / ORAL75 mgExact identifier — unii candidate
79 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / OPHTHALMIC6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SUSPENSION / INTRAVENOUS0.9 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHPOWDER, FOR SOLUTION / ORAL13 mgExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSYSTEM / TOPICAL42 mgExact identifier — unii candidate
79 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XDROPS / ORALNAExact identifier — unii candidate
134 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS15 mgExact identifier — unii candidate
79 equally ranked IID candidates
TALCTALC7SEV7J4R1UGRANULE, FOR SUSPENSION / ORAL296 mgExact identifier — unii candidate
35 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRATUMOR1.2 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KGEL / TOPICAL8 mgExact identifier — unii candidate
32 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XELIXIR / ORAL1 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XGEL / OPHTHALMIC0.9 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
TALCTALC7SEV7J4R1USUSPENSION / ORAL234 mgExact identifier — unii candidate
35 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8CAPSULE / ORALNAExact identifier — unii candidate
15 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION, SOLUTION / INTRAMUSCULAR5 mgExact identifier — unii candidate
68 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / EPIDURAL3535 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION / RESPIRATORY (INHALATION)108 mgExact identifier — unii candidate
134 equally ranked IID candidates
TALCTALC7SEV7J4R1UGUM, CHEWING / BUCCALNAExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, EXTENDED RELEASE / ORAL300 mgExact identifier — unii candidate
35 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / AURICULAR (OTIC)63.64 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR226 mgExact identifier — unii candidate
134 equally ranked IID candidates
ASCORBYL PALMITATEASCORBYL PALMITATEQN83US2B0NSYSTEM / TOPICAL0.04 mgExact identifier — unii candidate
6 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, DELAYED RELEASE PARTICLES / ORAL56 mgExact identifier — unii candidate
35 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / SUBCUTANEOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TJELLY / TOPICAL420 mgExact identifier — unii candidate
79 equally ranked IID candidates
ASCORBYL PALMITATEASCORBYL PALMITATEQN83US2B0NSUPPOSITORY / RECTAL16 mgExact identifier — unii candidate
6 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSUSPENSION / OPHTHALMIC10 mgExact identifier — unii candidate
134 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDROPS / NASAL10 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXJELLY / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XTABLET, DELAYED RELEASE / ORAL97 mgExact identifier — unii candidate
134 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KSUPPOSITORY / RECTAL1 mgExact identifier — unii candidate
32 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION / EPIDURAL0.9 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET / ORAL1000 mgExact identifier — unii candidate
35 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SUSPENSION / SOFT TISSUE26 mgExact identifier — unii candidate
134 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TENEMA / RECTAL0.18 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET / ORAL750 mgExact identifier — unii candidate
49 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINHALANT / RESPIRATORY (INHALATION)3 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XPOWDER, FOR SOLUTION / OPHTHALMIC0.9 %w/wExact identifier — unii candidate
134 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSOLUTION / INTRAMUSCULAR0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSUSPENSION / RESPIRATORY (INHALATION)43 mgExact identifier — unii candidate
134 equally ranked IID candidates
TALCTALC7SEV7J4R1UELIXIR / ORAL4.5 mg/5mlExact identifier — unii candidate
35 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHTABLET / ORAL0.2 mgExact identifier — unii candidate
68 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXELIXIR / ORAL5621 mgExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSUPPOSITORY / VAGINALNAExact identifier — unii candidate
68 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KOINTMENT / TOPICAL57 mgExact identifier — unii candidate
32 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSUSPENSION / AURICULAR (OTIC)NAExact identifier — unii candidate
68 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / AURICULAR (OTIC)25 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SUSPENSION, LIPOSOMAL / EPIDURAL11 mgExact identifier — unii candidate
134 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION/ DROPS / OPHTHALMIC0.05 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / INTRATHECAL131 mgExact identifier — unii candidate
134 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4FILM, EXTENDED RELEASE / TRANSDERMAL49 mgExact identifier — unii candidate
49 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXEMULSION / INTRAVENOUS2.2 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XLIQUID / NASAL7.4 mg/1mlExact identifier — unii candidate
134 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TFILM / BUCCAL1 mgExact identifier — unii candidate
79 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
e5a7e429-a4c6-4bfa-88fb-d2346d42cfe997bc9457-aba6-4c0d-8873-5babd585a72d2011-01-13WarningsExact identifier
spl id: e5a7e429-a4c6-4bfa-88fb-d2346d42cfe9
spl set id: 97bc9457-aba6-4c0d-8873-5babd585a72d

Reported adverse events (FAERS/openFDA)#

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