FDA.reportPublic FDA data

simple ® vital vitamin DAY CREAM

Manufacturer
Cosmetic Laboratories of America
Effective date
2011-08-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:30:31

Label at a glance#

ProductSimple Vital Vitamin Day SPF 15
Active ingredientHomosalate, Octisalate, Avobenzone, Octocrylene
Label structure10 sections

Dosage and administration

After cleansing, apply evenly to face and neck with fingertips prior to sun exposure. For children under 6 months of age, ask doctor.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active Ingredients:Purpose:
Homosalate 12.0%Sunscreen
Octisalate 5.0%Sunscreen
Avobenzone 3.0%Sunscreen
Octocrylene 2.7%Sunscreen

USE

INDICATIONS & USAGE SECTION

helps prevent sunburn.

Warnings

WARNINGS SECTION

  • For external use only.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

OTC - WHEN USING SECTION

  • When using this product keep out of eyes.
    Rinse with water to remove.

OTC - STOP USE SECTION

  • Stop use and ask a doctor if a rash and irritation develops and lasts.

Other Information

SPL UNCLASSIFIED SECTION

Intended for moderate daily sun protection from incidental sun exposure. For prolonged sun exposure, use additional sunscreen.

Directions

DOSAGE & ADMINISTRATION SECTION

After cleansing, apply evenly to face and neck with fingertips prior to sun exposure. For children under 6 months of age, ask doctor.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua, Eau), Glycerin, C12-15 Alkyl Benzoate, Silica, Pentylene Glycol, Tocopheryl Acetate, Panthenol, Cetearyl Alcohol, Steareth-21, Steareth-2, Arachidyl Alcohol, Polyacrylamide, Caprylyl Glycol, Behenyl Alcohol, C13-14 Isoparaffin, Disodium EDTA, Xanthan Gum, Cetearyl Glucoside, Arachidyl Glucoside, Allantoin, Bisabolol, Laureth-7, Triethanolamine, Methylisothiazolinone, Phenoxyethanol.

Questions?

OTC - QUESTIONS SECTION

1-866-752-4602

SPL UNCLASSIFIED SECTION

Distributed by: Alberto Culver USA, Inc.
Melrose Park, IL 60160

PRINCIPAL DISPLAY PANEL - 50g Jar Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW!

simple ®

SENSITIVE SKIN EXPERTS

vital vitamin
D A Y   C R E A M
SPF 15 | UVA/UVB SUNSCREENS

KIND TO SKIN

2
VITAL
VITAMINS

3
SKIN LOVING
NUTRIENTS

0
NO PERFUME
NO DYES

Vitamin goodness
for naturally healthy
looking skin

net wt
1.7 oz | 50g

Principal Display Panel - 50g Jar Carton
Principal Display Panel - 50g Jar Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54726-2000-12019-10-29C16284748780-1960f7f55-d0a3-8e05-e053-dbdaa90a074asimple ® vital vitamin DAY CREAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54726-2000-1Simple Vital Vitamin Day SPF 151 in 1 CARTONEMULSION11
54726-2000-1Simple Vital Vitamin Day SPF 1550 g in 1 JAREMULSION501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54726-2000SIMPLE VITAL VITAMIN DAY SPF 15 (HOMOSALATE, OCTISALATE, AVOBENZONE, AND OCTOCRYLENE) EMULSION [COSMETIC LABORATORIES OF AMERICA]1Legacy NDC, 2 package rows20120103_ce6ba6de-3c73-494a-a7da-9ac7f4be6358.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AvobenzoneACTIVE INGREDIENTG63QQF2NOX1
HomosalateACTIVE INGREDIENTV06SV4M95S1
OctisalateACTIVE INGREDIENT4X49Y0596W1
OctocryleneACTIVE INGREDIENT5A68WGF6WM1
AvobenzoneACTIVE MOIETYG63QQF2NOX1
HomosalateACTIVE MOIETYV06SV4M95S1
OctisalateACTIVE MOIETY4X49Y0596W1
OctocryleneACTIVE MOIETY5A68WGF6WM1
Alkyl (C12-15) BenzoateINACTIVE INGREDIENTA9EJ3J61HQ1
AllantoinINACTIVE INGREDIENT344S277G0Z1
Arachidyl AlcoholINACTIVE INGREDIENT1QR1QRA9BU1
Arachidyl GlucosideINACTIVE INGREDIENT6JVW35JOOJ1
C13-14 IsoparaffinINACTIVE INGREDIENTE4F12ROE701
Caprylyl GlycolINACTIVE INGREDIENT00YIU5438U1
Cetearyl GlucosideINACTIVE INGREDIENT09FUA47KNA1
Cetostearyl AlcoholINACTIVE INGREDIENT2DMT128M1S1
DocosanolINACTIVE INGREDIENT9G1OE216XY1
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86K1
GlycerinINACTIVE INGREDIENTPDC6A3C0OX1
Laureth-7INACTIVE INGREDIENTZ95S6G82011
LevomenolINACTIVE INGREDIENT24WE03BX2T1
MethylisothiazolinoneINACTIVE INGREDIENT229D0E1QFA1
PanthenolINACTIVE INGREDIENTWV9CM0O67Z1
Pentylene GlycolINACTIVE INGREDIENT50C1307PZG1
PhenoxyethanolINACTIVE INGREDIENTHIE492ZZ3T1
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU41
Steareth-2INACTIVE INGREDIENTV56DFE46J51
Steareth-21INACTIVE INGREDIENT53J3F32P581
TrolamineINACTIVE INGREDIENT9O3K93S3TK1
WaterINACTIVE INGREDIENT059QF0KO0R1
Xanthan GumINACTIVE INGREDIENTTTV12P4NEE1

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
54726-200054726-2000-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
HomosalateV06SV4M95SACTIB
Octisalate4X49Y0596WACTIB
AvobenzoneG63QQF2NOXACTIB
Octocrylene5A68WGF6WMACTIB
Water059QF0KO0RIACT
GlycerinPDC6A3C0OXIACT
Alkyl (C12-15) BenzoateA9EJ3J61HQIACT
Silicon DioxideETJ7Z6XBU4IACT
Pentylene Glycol50C1307PZGIACT
PanthenolWV9CM0O67ZIACT
Cetostearyl Alcohol2DMT128M1SIACT
Steareth-2153J3F32P58IACT
Steareth-2V56DFE46J5IACT
Arachidyl Alcohol1QR1QRA9BUIACT
Caprylyl Glycol00YIU5438UIACT
Docosanol9G1OE216XYIACT
C13-14 IsoparaffinE4F12ROE70IACT
Edetate Disodium7FLD91C86KIACT
Xanthan GumTTV12P4NEEIACT
Cetearyl Glucoside09FUA47KNAIACT
Arachidyl Glucoside6JVW35JOOJIACT
Allantoin344S277G0ZIACT
Levomenol24WE03BX2TIACT
Laureth-7Z95S6G8201IACT
Trolamine9O3K93S3TKIACT
Methylisothiazolinone229D0E1QFAIACT
PhenoxyethanolHIE492ZZ3TIACT

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 5 · 276 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4TABLET, DELAYED RELEASE / ORAL1190 mgExact identifier — unii candidate
49 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXOINTMENT / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
Cetostearyl AlcoholCETOSTEARYL ALCOHOL2DMT128M1SCREAM / TOPICAL1428 mgExact identifier — unii candidate
9 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSHAMPOO / TOPICAL5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXTABLET, EXTENDED RELEASE / ORAL7 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
Cetostearyl AlcoholCETOSTEARYL ALCOHOL2DMT128M1SAEROSOL, FOAM / TOPICAL21 mgExact identifier — unii candidate
9 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4TABLET, EXTENDED RELEASE / ORAL450 mgExact identifier — unii candidate
49 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEESOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC0.6 %w/wExact identifier — unii candidate
29 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEEPOWDER, FOR SUSPENSION / ORAL600 mgExact identifier — unii candidate
29 equally ranked IID candidates
TrolamineTROLAMINE9O3K93S3TKEMULSION / TOPICAL0.5 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEESUSPENSION/ DROPS / ORAL22 mgExact identifier — unii candidate
29 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXELIXIR / ORAL5621 mgExact identifier — unii candidate
75 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4TABLET, COATED / ORAL176 mgExact identifier — unii candidate
49 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION / SUBCUTANEOUS450 mgExact identifier — unii candidate
75 equally ranked IID candidates
TrolamineTROLAMINE9O3K93S3TKLIQUID / TOPICALNAExact identifier — unii candidate
22 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KSOLUTION / TOPICAL1 mgExact identifier — unii candidate
77 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCREAM, AUGMENTED / TOPICAL55 mgExact identifier — unii candidate
75 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KGEL / TOPICAL24 mgExact identifier — unii candidate
77 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KSUSPENSION/ DROPS / AURICULAR (OTIC)0.01 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KINJECTION, SOLUTION / INTRAMUSCULAR4 mgExact identifier — unii candidate
77 equally ranked IID candidates
Steareth-21STEARETH-2153J3F32P58LOTION / TOPICAL3 %w/wExact identifier — unii candidate
2 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KSUSPENSION/ DROPS / ORAL4 mgExact identifier — unii candidate
77 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION, CONCENTRATE / ORAL200 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KENEMA / RECTAL60 mgExact identifier — unii candidate
77 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4POWDER / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
49 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KSPRAY / RESPIRATORY (INHALATION)0.05 %w/wExact identifier — unii candidate
77 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KSUSPENSION, EXTENDED RELEASE / ORAL40 mgExact identifier — unii candidate
77 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXJELLY / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEESUSPENSION, EXTENDED RELEASE / ORAL186.8 mgExact identifier — unii candidate
29 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KSOLUTION / ORAL432 mgExact identifier — unii candidate
77 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4LOZENGE / ORAL120 mgExact identifier — unii candidate
49 equally ranked IID candidates
TrolamineTROLAMINE9O3K93S3TKLOTION / TOPICAL360 mgExact identifier — unii candidate
22 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KSYRUP / ORAL40 mgExact identifier — unii candidate
77 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION/ DROPS / AURICULAR (OTIC)25 mgExact identifier — unii candidate
75 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEESUSPENSION / OPHTHALMIC2 mgExact identifier — unii candidate
29 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEEGRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL2350 mgExact identifier — unii candidate
29 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSYSTEM / TOPICAL18144 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXTABLET / ORAL42 mgExact identifier — unii candidate
75 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS19 mgExact identifier — unii candidate
77 equally ranked IID candidates
TrolamineTROLAMINE9O3K93S3TKCREAM / VAGINAL56 mgExact identifier — unii candidate
22 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSYSTEM / IONTOPHORESIS168.1 mgExact identifier — unii candidate
75 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KINJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS0.4 mgExact identifier — unii candidate
77 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KSUSPENSION / AURICULAR (OTIC)0.01 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSPRAY, METERED / NASAL13 mgExact identifier — unii candidate
75 equally ranked IID candidates
Cetostearyl AlcoholCETOSTEARYL ALCOHOL2DMT128M1STABLET, EXTENDED RELEASE / ORAL800 mgExact identifier — unii candidate
9 equally ranked IID candidates
PhenoxyethanolPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KSPRAY / NASAL1 mgExact identifier — unii candidate
77 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4TABLET, ORALLY DISINTEGRATING / ORAL68 mgExact identifier — unii candidate
49 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXEMULSION / INTRAVENOUS2.2 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4SOLUTION / ORAL336 mgExact identifier — unii candidate
49 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUSPENSION / AURICULAR (OTIC)0.05 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEESOLUTION / OPHTHALMIC0.6 %w/vExact identifier — unii candidate
29 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KSPRAY, METERED / NASAL4 mgExact identifier — unii candidate
77 equally ranked IID candidates
TrolamineTROLAMINE9O3K93S3TKSOAP / TOPICAL0.08 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4GEL / VAGINAL8 %w/wExact identifier — unii candidate
49 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCAPSULE, EXTENDED RELEASE / ORAL265 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / OPHTHALMIC2.5 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSPRAY / NASAL22.3 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4TABLET / ORAL750 mgExact identifier — unii candidate
49 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
776c244d-d5c0-427f-bc9c-32e43af267dfce6ba6de-3c73-494a-a7da-9ac7f4be63582011-08-31WarningsExact identifier
spl id: 776c244d-d5c0-427f-bc9c-32e43af267df
spl set id: ce6ba6de-3c73-494a-a7da-9ac7f4be6358

Reported adverse events (FAERS/openFDA)#

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