FDA.reportPublic FDA data

Timeless Age Defying SPF 20

Manufacturer
Merle Norman
Effective date
2017-01-23
Label type
HUMAN OTC DRUG LABEL
Version
16
Source
full-release
Hydrated at
2026-05-31 22:48:37

Label at a glance#

ProductTimeless Age Defying SPF 20 Merle Norman
Active ingredientOCTINOXATE, OXYBENZONE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients          purpose

Octinoxate 7.5%            Sunscreen

Oxybenzone 2.0%         Sunscreen

OTC - PURPOSE SECTION

Uses
· helps prevent sunburn
· If used as directed with other sun protection measures (see Directions),
decreases the risk of skin cancer and early skin aging caused by the sun

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is swallowed, get medical help or
contact a Poison Control Center right away.

INDICATIONS & USAGE SECTION

Stop use and ask a doctor if rash occurs

WARNINGS SECTION

Warnings

· For external use only
· Do not use on damaged or broken skin
· When using this product keep out of eyes. Rinse with water to remove.

DOSAGE & ADMINISTRATION SECTION

Directions

For sunscreen use:

· Apply liberally 15 minutes before sun exposure

· Use a water resistant sunscreen if swimming or sweating

· Reapply at least every 2 hours

· Sun Protection Measures. Spending time in the sun increases your risk of skin
cancer and early skin aging. To decrease this risk, regularly use a sunscreen
with broad spectrum SPF of 15 or higher and other sun protection measures
including:
· limit time in the sun, especially from 10 a.m. - 2 p.m.
· wear long-sleeve shirts, pants, hats, and sunglasses
· Children under 6 months: Ask a doctor

INACTIVE INGREDIENT SECTION

Inactive ingredients: Water (Aqua), Titanium Dioxide, Butylene Glycol, Octldodecyl Neopentanoate, Cyclopentasoloxane, Isodecyl Neopentanoate, Iron Oxides, Stearic Acid, Phenyl Trimethicone, Propylene Glycol Stearate SE, Squalane, Triethanolamine, Dipalmitoyl Hydroxyproline, Trilaurin, Ceramide 3, Hyaluronic Acid, Glycine Soja, ( Soybean) Seed Extract, Atelocollagen, Sodium Hyaluronate, Palmitoyl Oligopeptide, Ascorbyl Palmitate, Tocopheryl Acetate, Propylene Glycol Dipelargonate, Ethylene/ Acrylic Acid Copolymer, Panthenol, Allantoin, Lecithin, Glyceryl Polymethacrylate, Dimethionol, Cetyl Phosphate, Tricaprylin, Mica ( Cl 77019), Stearyl Alcohol, PEG-8, Cellulose gum, PEG-12 Dimethicone, Silica, Polyquaternium-24, Sodium Chondroitin Sulfate, Magnesium Aluminum Silicate, Carbomer, Polysorbate 20, Tetrasodium EDTA, Disodium EDTA, Diazolidinyl Urea, BHT, Ethylene Dodecanedioate Phenoxyethanol

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Timeless

Age-Defying Makeup SPF 20

Merle Norman

30 mL 1 FL. OZ.

cartoncarton

bottlebottle

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57627-115-022020-01-31C16284748780-19d75b9d0-18d9-f424-e053-dadaa90a57ceTimeless Age-Defying Makeup SPF 20

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57627-115-01Timeless Age Defying SPF 20Merle Norman30 mL in 1 BOTTLECREAM3016
57627-115-02Timeless Age Defying SPF 20Merle Norman1 in 1 BOXCREAM116

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57627-115TIMELESS AGE DEFYING SPF 20 MERLE NORMAN (OCTINOXATE, OXYBENZONE) CREAM [MERLE NORMAN]16Legacy NDC, 2 package rows20170124_cae1e33b-d41f-454d-8a16-ff41bd6663dc.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD5111
OXYBENZONEACTIVE INGREDIENT95OOS7VE0Y11
OCTINOXATEACTIVE MOIETY4Y5P7MUD5111
OXYBENZONEACTIVE MOIETY95OOS7VE0Y11
.ALPHA.-TOCOPHEROL ACETATE, D-INACTIVE INGREDIENTA7E6112E4N11
1,3-BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA11
ALLANTOININACTIVE INGREDIENT344S277G0Z11
ASCORBYL PALMITATEINACTIVE INGREDIENTQN83US2B0N11
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171K11
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS31111
CERAMIDE 3INACTIVE INGREDIENT4370DF050B11
CETYL PHOSPHATEINACTIVE INGREDIENTVT07D6X67O11
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW411
DIPALMITOYL HYDROXYPROLINEINACTIVE INGREDIENTE6AHA53N1H11
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K11
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LU11
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G67511
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRT11
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F35711
FERROUS OXIDEINACTIVE INGREDIENTG7036X8B5H11
HYALURONATE SODIUMINACTIVE INGREDIENTYSE9PPT4TH11
HYALURONIC ACIDINACTIVE INGREDIENTS270N0TRQY11
ISODECYL NEOPENTANOATEINACTIVE INGREDIENTW60VYE24XC11
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NC11
MICAINACTIVE INGREDIENTV8A1AW088011
PALMITOYL OLIGOPEPTIDEINACTIVE INGREDIENTHO4ZT5S86C11
PANTHENOLINACTIVE INGREDIENTWV9CM0O67Z11
PEG-12 DIMETHICONE (300 CST)INACTIVE INGREDIENTZEL54N6W9511
PHENYL TRIMETHICONEINACTIVE INGREDIENTDR0K5NOJ4R11
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQ11
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YH11
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU411
SOYBEANINACTIVE INGREDIENTL7HT8F1ZOD11
SQUALANEINACTIVE INGREDIENTGW89575KF911
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP11
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1Y11
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP11
TRICAPRYLININACTIVE INGREDIENT6P9285898811
TRILAURININACTIVE INGREDIENT7FP2Z3RVUV11
TROLAMINEINACTIVE INGREDIENT9O3K93S3TK11

Products#

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

DailyMed product names page 1 of 1 · 40 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57627-11557627-115-01, 57627-115-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 38 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTINOXATE4Y5P7MUD51ACTIB
OXYBENZONE95OOS7VE0YACTIB
TITANIUM DIOXIDE15FIX9V2JPIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
ISODECYL NEOPENTANOATEW60VYE24XCIACT
FERROUS OXIDEG7036X8B5HIACT
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
STEARIC ACID4ELV7Z65APIACT
PHENYL TRIMETHICONEDR0K5NOJ4RIACT
SQUALANEGW89575KF9IACT
TROLAMINE9O3K93S3TKIACT
DIPALMITOYL HYDROXYPROLINEE6AHA53N1HIACT
TRILAURIN7FP2Z3RVUVIACT
CERAMIDE 34370DF050BIACT
HYALURONIC ACIDS270N0TRQYIACT
SOYBEANL7HT8F1ZODIACT
HYALURONATE SODIUMYSE9PPT4THIACT
PALMITOYL OLIGOPEPTIDEHO4ZT5S86CIACT
ASCORBYL PALMITATEQN83US2B0NIACT
.ALPHA.-TOCOPHEROL ACETATE, D-A7E6112E4NIACT
PANTHENOLWV9CM0O67ZIACT
ALLANTOIN344S277G0ZIACT
CETYL PHOSPHATEVT07D6X67OIACT
TRICAPRYLIN6P92858988IACT
MICAV8A1AW0880IACT
STEARYL ALCOHOL2KR89I4H1YIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
PEG-12 DIMETHICONE (300 CST)ZEL54N6W95IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
POLYSORBATE 207T1F30V5YHIACT
EDETATE SODIUMMP1J8420LUIACT
EDETATE DISODIUM7FLD91C86KIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT

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 8 · 475 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
POLYSORBATE 20POLYSORBATE 207T1F30V5YHINJECTION / INTRAVENOUS30 mgExact identifier — unii candidate
28 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHINJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR60 mgExact identifier — unii candidate
28 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KINJECTION, POWDER, FOR SOLUTION / INTRAVENOUSNAExact identifier — unii candidate
32 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, DELAYED RELEASE PARTICLES / ORAL170 mgExact identifier — unii candidate
49 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311FILM / BUCCAL18 mgExact identifier — unii candidate
44 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311POWDER, FOR SUSPENSION / INTRAMUSCULAR0.7 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357CAPSULE, COATED / ORAL0.11 mgExact identifier — unii candidate
10 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APIMPLANT / SUBCUTANEOUS1.04 mgExact identifier — unii candidate
26 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KDROPS / OPHTHALMIC0.05 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APAEROSOL, FOAM / TOPICAL8 %w/wExact identifier — unii candidate
26 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKAEROSOL, FOAM / TOPICAL2.6 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
HYALURONATE SODIUMHYALURONATE SODIUMYSE9PPT4THINJECTION, SUSPENSION / INTRAVITREAL23 mgExact identifier — unii candidate
5 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET, COATED / ORAL1 mgExact identifier — unii candidate
20 equally ranked IID candidates
ASCORBYL PALMITATEASCORBYL PALMITATEQN83US2B0NSYSTEM / TOPICAL0.04 mgExact identifier — unii candidate
6 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, FOR SUSPENSION / ORAL220 mgExact identifier — unii candidate
49 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET / SUBLINGUAL9 mgExact identifier — unii candidate
26 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311PASTE, DENTIFRICE / DENTAL1.2 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KTABLET, FOR SUSPENSION / ORAL0.1 mgExact identifier — unii candidate
32 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPINSERT, EXTENDED RELEASE / OPHTHALMIC0.4 mgExact identifier — unii candidate
40 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCTABLET, EXTENDED RELEASE / ORAL70 mgExact identifier — unii candidate
17 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSPRAY / RESPIRATORY (INHALATION)0.05 %w/wExact identifier — unii candidate
77 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL0.15 mgExact identifier — unii candidate
21 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311INJECTION / INTRA-ARTICULAR25 mgExact identifier — unii candidate
44 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHEMULSION / TOPICAL2 %w/wExact identifier — unii candidate
28 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUSOAP / TOPICAL0.12 %w/wExact identifier — unii candidate
12 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KCAPSULE, LIQUID FILLED / ORAL0.1 mgExact identifier — unii candidate
32 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SOLUTION / ORAL3480 mgExact identifier — unii candidate
44 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPGUM, CHEWING / BUCCAL182 mgExact identifier — unii candidate
40 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCTABLET / ORAL60 mgExact identifier — unii candidate
17 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS0.02 mgExact identifier — unii candidate
32 equally ranked IID candidates
ASCORBYL PALMITATEASCORBYL PALMITATEQN83US2B0NCAPSULE / ORAL12 mgExact identifier — unii candidate
6 equally ranked IID candidates
DIAZOLIDINYL UREADIAZOLIDINYL UREAH5RIZ3MPW4LOTION / TOPICAL3 %w/wExact identifier — unii candidate
3 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUCAPSULE / ORAL1 mgExact identifier — unii candidate
12 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQSYRUP / ORAL740 mgExact identifier — unii candidate
36 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQSOLUTION/ DROPS / OPHTHALMIC1 %w/vExact identifier — unii candidate
36 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311CAPSULE / ORAL160 mgExact identifier — unii candidate
44 equally ranked IID candidates
STEARYL ALCOHOLSTEARYL ALCOHOL2KR89I4H1YAEROSOL, FOAM / TOPICAL37 mgExact identifier — unii candidate
12 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQSOLUTION / TOPICAL11100 mgExact identifier — unii candidate
36 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQFILM, SOLUBLE / ORAL29 mgExact identifier — unii candidate
36 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KTABLET, ORALLY DISINTEGRATING / ORAL1 mgExact identifier — unii candidate
32 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357TABLET, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
10 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / AURICULAR (OTIC)0.1 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SUSPENSION / ORAL1080 mgExact identifier — unii candidate
44 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4PASTE / DENTAL34 %w/wExact identifier — unii candidate
49 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUINJECTION, SOLUTION / INTRAVENOUS0.04 %w/vExact identifier — unii candidate
12 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKSOLUTION / NASALNAExact identifier — unii candidate
22 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQSUPPOSITORY / VAGINAL30 mgExact identifier — unii candidate
36 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KTABLET, ORALLY DISINTEGRATING / ORAL3 mgExact identifier — unii candidate
77 equally ranked IID candidates
FERROUS OXIDEFERROUS OXIDEG7036X8B5HTABLET, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
3 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675LOTION / TOPICALNAExact identifier — unii candidate
21 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQCAPSULE, LIQUID FILLED / ORAL1122 mgExact identifier — unii candidate
36 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APSOAP / TOPICAL6 %w/wExact identifier — unii candidate
26 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, COATED / ORAL42.4 mgExact identifier — unii candidate
26 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / INFILTRATION6 mgExact identifier — unii candidate
77 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQCONCENTRATE / ORAL3000 mgExact identifier — unii candidate
36 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KINJECTION / INTRAVENOUSNAExact identifier — unii candidate
32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KINJECTION, SOLUTION / INTRAVENOUSNAExact identifier — unii candidate
32 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KGEL / TRANSDERMAL1 mgExact identifier — unii candidate
77 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357CAPSULE, DELAYED RELEASE / ORAL6 mgExact identifier — unii candidate
10 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKAEROSOL, METERED / RECTALADJ PHExact identifier — unii candidate
22 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
40ef2014-88ce-4b0d-9e2c-fdfc0be386d1cae1e33b-d41f-454d-8a16-ff41bd6663dc2017-01-23WarningsExact identifier
spl id: 40ef2014-88ce-4b0d-9e2c-fdfc0be386d1
spl set id: cae1e33b-d41f-454d-8a16-ff41bd6663dc

Reported adverse events (FAERS/openFDA)#

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