Ceramide Premier Intense Moisture and Renewal Activation Broad Spectrum SPF 30

Manufacturer
Elizabeth Arden, Inc
Effective date
2013-04-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:35:17

Label at a glance#

ProductCeramide Premier Intense Moisture and Renewal Activation Broad Spectrum SPF 30
Active ingredientOCTINOXATE, OCTISALATE, OXYBENZONE, OCTOCRYLENE, AVOBENZONE
Label structure10 sections

Indications and uses

Apply to face and throat.

Dosage and administration

To Use: Apply to cleansed face and throat. Directions For Sunscreen Use:Apply liberally 15 minutes before sun exposure. 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 mthis risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: Limit time in the sun,...

Label contents#

Full prescribing information#

DESCRIPTION

DESCRIPTION SECTION

This rich, replenishing moisture cream with skin identical Ceramide Triple Complex hydrates deeply to restore skin's natural protective barrier and ease the look of fine lines and wrinkles. Nutrient rich sea minerals including calcium help support skin’s natural processes to fortify thin, fragile looking skin. Our patented retinyl complex is clinically proven to optimize surface cell turnover to improve the appearance of age spots, discolorations and overall radiance.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

To Use: Apply to cleansed face and throat.

Directions For Sunscreen Use:Apply liberally 15 minutes before sun exposure. 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 mthis risk, regularly use a sunscreen with a 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.

 

OTC - ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: Octinoxate 7.5%, Octisalate 5.0%, Oxybenzone 4.0%, Octocrylene 3.0%, Avobenzone 2.0%.

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Water/Aqua/Eau, Dimethicone, Glycerin, Hydrogenated Polyisobutene, Petrolatum, Glyceryl Stearate, Butylene Glycol, Butyloctly Salicylate, Caprylic/Capric Triglyceride, Cetearyl Alochol, PEG-100 Stearate, Butyrospermum Parkii (Shea Butter), Hydrogenated Lecithin, Dimethylcapramide, Ceramide 1, Ceramide 3, Ceramide 6 II, Fucus Serratus Extract, Yeast Extract/Faex/Extrait de Levure, Retinyl Lonoleate, Tocopheryl Acetate, Cetearyl Dimethicone Crosspolymer, PEG-40 Hydrogenated Castor Oil, Soy Amino Acids, 3-Aminopropane Sulfonic Acid, Calcium Hydroxymethionine, Hydrolyzed Soy Protein, Methyl Methacrylate Crosspolymer, Phytosphingosine, Ammonium Acryloyldimethyltaurate/VP Copolymer, Cholesterol, Sodium Lauroyl Lactylate, PEG-8 Laurate, Polysorbate 20, Sodium Dodecylbenzenesulfonate, Styrene/Acrylates Copolymer, Behenyl Alcohol, Pentylene Glycol, Carbomer, Hydroxyethylcellulose, Polyethylene, Xanthan Gum, EDTA, Sodium Hydroxide, BHT, Disodium EDTA, Mica, Tin Oxide, Aminopropyl Dimethicone, Fragrance/Parfum, Alpha-Isomethyl Ionone, Butylpheyl Methylpropional, Citronellol, Hydroxycitronellal, Ethylparaben, Methylparaben, Phenoxyethanol, Potassium Sorbate, Propylparaben, Sodium Benzoate, Titanium Dioxide (CI 77891).

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Apply to face and throat.

OTC - KEEP OUT OF REACH OF CHILDREN

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.

OTC - PURPOSE

OTC - PURPOSE SECTION

Provides SPF 30 Sun Protection.

OTC - WHEN USING

OTC - WHEN USING SECTION

Keep out of eyes.

WARNINGS

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.

Stop use and ask a doctor if rash occurs.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PremiereActivationCartonPremiereActivationCartonPremiereActivationOnsertPremiereActivationOnsert

PremierActivationBaseLabelPremierActivationBaseLabel

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67938-1145-12020-01-31C16284748780-19d75b9d0-948a-f424-e053-dadaa90a57ceBC1145

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67938-1145-1Ceramide Premier Intense Moisture and Renewal Activation Broad Spectrum SPF 301 in 1 JARCREAM11
67938-1145-2Ceramide Premier Intense Moisture and Renewal Activation Broad Spectrum SPF 3049 g in 1 CARTONCREAM491

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67938-1145CERAMIDE PREMIER INTENSE MOISTURE AND RENEWAL ACTIVATION BROAD SPECTRUM SPF 30 (OCTINOXATE, OCTISALATE, OXYBENZONE, OCTOCRYLENE, AND AVOBENZONE) CREAM [ELIZABETH ARDEN, INC]1Legacy NDC, 2 package rows20130430_ce3b375e-14fe-46d0-829e-ba850e191a42.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOX1
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD511
OCTISALATEACTIVE INGREDIENT4X49Y0596W1
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WM1
OXYBENZONEACTIVE INGREDIENT95OOS7VE0Y1
AVOBENZONEACTIVE MOIETYG63QQF2NOX1
OCTINOXATEACTIVE MOIETY4Y5P7MUD511
OCTISALATEACTIVE MOIETY4X49Y0596W1
OCTOCRYLENEACTIVE MOIETY5A68WGF6WM1
OXYBENZONEACTIVE MOIETY95OOS7VE0Y1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L01
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMERINACTIVE INGREDIENTW59H9296ZG1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171K1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA1
BUTYLOCTYL SALICYLATEINACTIVE INGREDIENT2EH13UN8D31
BUTYLPHENYL METHYLPROPIONALINACTIVE INGREDIENTT7540GJV691
CERAMIDE 1INACTIVE INGREDIENT5THT33P7X71
CERAMIDE 3INACTIVE INGREDIENT4370DF050B1
CERAMIDE 6 IIINACTIVE INGREDIENTF1X8L2B00J1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1S1
CHOLESTEROLINACTIVE INGREDIENT97C5T2UQ7J1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O1
DIMETHYL CAPRAMIDEINACTIVE INGREDIENTO29Y6X2JEZ1
DOCOSANOLINACTIVE INGREDIENT9G1OE216XY1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K1
EDETIC ACIDINACTIVE INGREDIENT9G34HU7RV01
ETHYLPARABENINACTIVE INGREDIENT14255EXE391
FUCUS SERRATUSINACTIVE INGREDIENTV8K40WNW5B1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
HIGH DENSITY POLYETHYLENEINACTIVE INGREDIENTUG00KM4WR71
HYDROGENATED SOYBEAN LECITHININACTIVE INGREDIENTH1109Z9J4N1
HYDROXYCITRONELLALINACTIVE INGREDIENT8SQ0VA4YUR1
ISOMETHYL-.ALPHA.-IONONEINACTIVE INGREDIENT9XP4LC555B1
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7U1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T1
MICAINACTIVE INGREDIENTV8A1AW08801
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999R1
PEG-8 LAURATEINACTIVE INGREDIENT762O8IWA101
PENTYLENE GLYCOLINACTIVE INGREDIENT50C1307PZG1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9U1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1
PHYTOSPHINGOSINEINACTIVE INGREDIENTGIN46U9Q2Q1
POLYOXYL 40 HYDROGENATED CASTOR OILINACTIVE INGREDIENT7YC686GQ8F1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YH1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ41
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH1
RETINYL LINOLEATEINACTIVE INGREDIENT61911N8D6W1
SHEA BUTTERINACTIVE INGREDIENTK49155WL9Y1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU1
SODIUM DODECYLBENZENESULFONATEINACTIVE INGREDIENT554127163Y1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I1
SODIUM LAUROYL LACTYLATEINACTIVE INGREDIENT7243K85WFO1
STANNIC OXIDEINACTIVE INGREDIENTKM7N50LOS61
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP1
TRAMIPROSATEINACTIVE INGREDIENT5K8EAX0G531
WATERINACTIVE INGREDIENT059QF0KO0R1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE1
YEASTINACTIVE INGREDIENT3NY3SM6B8U1

Products#

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

DailyMed product names page 1 of 2 · 55 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67938-114567938-1145-2, 67938-1145-1

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 53 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 13 · 778 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4CONCENTRATE / ORAL1 mgExact identifier — unii candidate
19 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4SOLUTION / RECTAL6.67 %w/vExact identifier — unii candidate
19 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INFILTRATIONADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UEMULSION / TOPICAL7.8 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / RECTALNAExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INFILTRATIONADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ICREAM / VAGINAL0.19 %w/wExact identifier — unii candidate
174 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT, AUGMENTED / TOPICAL81.94 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXELIXIR / ORAL5621 mgExact identifier — unii candidate
75 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4AEROSOL, FOAM / TOPICAL8 mgExact identifier — unii candidate
19 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / SUBCUTANEOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
EDETIC ACIDEDETIC ACID9G34HU7RV0SUSPENSION / AURICULAR (OTIC)NAExact identifier — unii candidate
13 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM, AUGMENTED / TOPICAL10 mgExact identifier — unii candidate
6 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSUSPENSION / TOPICAL0.24 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KTABLET, COATED / ORAL0.21 mgExact identifier — unii candidate
77 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION, SUSPENSION / INTRAMUSCULAR0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INTRACAUDALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE / DENTAL20 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / SOFT TISSUE0.15 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHPOWDER / ORALNAExact identifier — unii candidate
68 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KGEL / TRANSDERMAL1 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION/ DROPS / OPHTHALMIC0.13 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KAEROSOL, FOAM / TOPICAL4 mgExact identifier — unii candidate
32 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ILOTION, AUGMENTED / TOPICALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7OINTMENT / OPHTHALMICNAExact identifier — unii candidate
18 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSOLUTION / NASAL140 mgExact identifier — unii candidate
68 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UCREAM / TOPICAL3300 mgExact identifier — unii candidate
18 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KAEROSOL, FOAM / TOPICAL0.05 %w/wExact identifier — unii candidate
77 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TGEL / VAGINAL8 mgExact identifier — unii candidate
79 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRAMUSCULAR450 mgExact identifier — unii candidate
75 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHINJECTION / SUBCUTANEOUSNAExact identifier — unii candidate
28 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IFILM, EXTENDED RELEASE / TRANSDERMAL0.85 mgExact identifier — unii candidate
174 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7TAPE / TOPICALNAExact identifier — unii candidate
18 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ILIQUID / INTRAMUSCULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUENEMA / RECTAL60 mgExact identifier — unii candidate
35 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UGEL / TOPICAL12 mgExact identifier — unii candidate
18 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7PASTE / DENTAL60 mgExact identifier — unii candidate
18 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUPASTE / ORAL28 mgExact identifier — unii candidate
35 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SCAPSULE, EXTENDED RELEASE / ORAL9.43 mgExact identifier — unii candidate
9 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / DENTAL15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSOLUTION / RESPIRATORY (INHALATION)0.01 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHTABLET / ORAL0.2 mgExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TPOWDER, FOR SOLUTION / ORAL126 mgExact identifier — unii candidate
79 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEENEMA / RECTAL150 mgExact identifier — unii candidate
29 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPSUPPOSITORY, EXTENDED RELEASE / INTRAUTERINE1 mgExact identifier — unii candidate
40 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET / PERIODONTAL0.53 mgExact identifier — unii candidate
75 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPSOAP / TOPICAL1 %w/wExact identifier — unii candidate
40 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ICAPSULE, COATED PELLETS / ORAL0.01 mgExact identifier — unii candidate
174 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPPOWDER / RESPIRATORY (INHALATION)2 mgExact identifier — unii candidate
40 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KSOLUTION / TOPICAL3 mgExact identifier — unii candidate
32 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KDROPS / AURICULAR (OTIC)0.05 %w/wExact identifier — unii candidate
77 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRA-ARTERIALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHSOAP / TOPICAL0.02 %w/wExact identifier — unii candidate
28 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSUSPENSION, EXTENDED RELEASE / ORAL4 mgExact identifier — unii candidate
68 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISPRAY, METERED / NASALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE, DENTIFRICE / DENTAL18 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, EXTENDED RELEASE / ORAL67 mgExact identifier — unii candidate
40 equally ranked IID candidates
CHOLESTEROLCHOLESTEROL97C5T2UQ7JINJECTABLE, LIPOSOMAL / INFILTRATION0.47 %w/vExact identifier — unii candidate
10 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCAPSULE, EXTENDED RELEASE / ORAL2 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
565e6022-cfef-4384-b96c-b5269ae5e711ce3b375e-14fe-46d0-829e-ba850e191a422013-04-30WarningsExact identifier
spl id: 565e6022-cfef-4384-b96c-b5269ae5e711
spl set id: ce3b375e-14fe-46d0-829e-ba850e191a42

Reported adverse events (FAERS/openFDA)#

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