FDA.reportPublic FDA data

help me

Manufacturer
Philosophy Inc. | Bio Tech Research Labs
Effective date
2012-04-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:32:02

Label at a glance#

Producthelp me broad spectrum spf 30 sunscreen retinol day treatment lotion
Active ingredientAvobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 2.0%

Homosalate 10.0%

Octisalate 5.0%

Octocrylene 1.5%

Oxybenzone 4.0%

OTC - PURPOSE SECTION

Avobenzone: Sunscreen

Homosalate: Sunscreen

Octisalate: Sunscreen

Octocrylene: Sunscreen

Oxybenzone: Sunscreen

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 right away.

INDICATIONS & USAGE SECTION

  • 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.

WARNINGS SECTION

For external use only.

Do not use on damaged or broken skin. If sensitive to retinol, use once every 2-3 days build to a daily use as tolerated.

When using this product keep out of eyes, rinse with water to remove.

Stop use and ask a doctor if rash occurs.

DOSAGE & ADMINISTRATION SECTION

  • apply liberally 15 minutes before sun exposure on clean dry skin, avoiding the eye area
  • reapply at least every 2 hours when using as a sunscreen
  • 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 a broad spectrum SPF of 15 or higher and other sun protection measures including:
                                 
                               limit time int he sun, especially from 10 a.m.-2 p.m.
                               wear long sleeve shirts, pants, hats and sunglasses
                               ask a doctor. this product should NOT be used on children of any age.

INACTIVE INGREDIENT SECTION

water, c12-15 alkyl benzoate, butylene glycol, glycerin, potassium cetyl phosphate, methyl methacrylate/glycol dimethacrylate crosspolymer, arachidyl alcohol, dimethicone, glyceryl myristate, peg-100 stearate, sodium hyaluronate, retinol, picea abies wood extract, ethylhexylglycerin, tocopheryl acetate, dipotassium glycyrrhizate, arachidyl glucoside, bentonite, allyl methacrylates crosspolymer, acrylates/c10-30 alkyl acrylate crosspolymer, behenyl alcohol, sodium hydroxide, disodium edta, bht, erythorbic acid, polysorbate 20, chlorphenesin, titanium dioxide, phenoxyethanol.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HelpMe_outerHelpMe_outer

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HelpMe_innerHelpMe_inner

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50184-1000-12019-11-13C16284748780-197449f38-d47b-f6ea-e053-dbdaa90aa703DRUG FACTS
50184-1000-22019-11-13C16284748780-197449f38-d47b-f6ea-e053-dbdaa90aa703DRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50184-1000-1help mebroad spectrum spf 30 sunscreen retinol day treatment lotion30 mL in 1 BOXLIQUID301
50184-1000-2help mebroad spectrum spf 30 sunscreen retinol day treatment lotion30 mL in 1 TUBELIQUID301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50184-1000HELP ME BROAD SPECTRUM SPF 30 SUNSCREEN RETINOL DAY TREATMENT LOTION (AVOBENZONE) LIQUID [PHILOSOPHY INC.]1Legacy NDC, 2 package rows20120523_b0dd8248-424d-44cb-a037-f2d894c8ec3a.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AvobenzoneACTIVE INGREDIENTG63QQF2NOX1
HomosalateACTIVE INGREDIENTV06SV4M95S1
OctisalateACTIVE INGREDIENT4X49Y0596W1
OctocryleneACTIVE INGREDIENT5A68WGF6WM1
OxybenzoneACTIVE INGREDIENT95OOS7VE0Y1
AvobenzoneACTIVE MOIETYG63QQF2NOX1
HomosalateACTIVE MOIETYV06SV4M95S1
OctisalateACTIVE MOIETY4X49Y0596W1
OctocryleneACTIVE MOIETY5A68WGF6WM1
OxybenzoneACTIVE MOIETY95OOS7VE0Y1
ALKYL (C12-15) BENZOATEINACTIVE INGREDIENTA9EJ3J61HQ1
ALPHA-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L01
arachidyl alcoholINACTIVE INGREDIENT1QR1QRA9BU1
arachidyl glucosideINACTIVE INGREDIENT6JVW35JOOJ1
bentoniteINACTIVE INGREDIENTA3N5ZCN45C1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171K1
butylene glycolINACTIVE INGREDIENT3XUS85K0RA1
chlorphenesinINACTIVE INGREDIENTI670DAL4SZ1
dimethiconeINACTIVE INGREDIENT92RU3N3Y1O1
DOCOSANOLINACTIVE INGREDIENT9G1OE216XY1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K1
erythorbic acidINACTIVE INGREDIENT311332OII11
ethylhexylglycerinINACTIVE INGREDIENT147D247K3P1
glycerinINACTIVE INGREDIENTPDC6A3C0OX1
glyceryl myristateINACTIVE INGREDIENT6992Y818271
GLYCYRRHIZINATE DIPOTASSIUMINACTIVE INGREDIENTCA2Y0FE3FX1
HYALURONATE SODIUMINACTIVE INGREDIENTYSE9PPT4TH1
peg-100 stearateINACTIVE INGREDIENTYD01N1999R1
phenoxyethanolINACTIVE INGREDIENTHIE492ZZ3T1
PICEA ABIES FLOWER BUDINACTIVE INGREDIENTWQZ50FAU2B1
polysorbate 20INACTIVE INGREDIENT7T1F30V5YH1
potassium cetyl phosphateINACTIVE INGREDIENT03KCY6P7UT1
retinolINACTIVE INGREDIENTG2SH0XKK911
sodium hydroxideINACTIVE INGREDIENT55X04QC32I1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JP1
WaterINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50184-100050184-1000-1, 50184-1000-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

Name, UNII, Kind table
NameUNIIKind
AvobenzoneG63QQF2NOXACTIB
HomosalateV06SV4M95SACTIB
Octisalate4X49Y0596WACTIB
Octocrylene5A68WGF6WMACTIB
Oxybenzone95OOS7VE0YACTIB
Water059QF0KO0RIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
butylene glycol3XUS85K0RAIACT
glycerinPDC6A3C0OXIACT
potassium cetyl phosphate03KCY6P7UTIACT
arachidyl alcohol1QR1QRA9BUIACT
dimethicone92RU3N3Y1OIACT
glyceryl myristate6992Y81827IACT
peg-100 stearateYD01N1999RIACT
HYALURONATE SODIUMYSE9PPT4THIACT
retinolG2SH0XKK91IACT
PICEA ABIES FLOWER BUDWQZ50FAU2BIACT
ethylhexylglycerin147D247K3PIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
GLYCYRRHIZINATE DIPOTASSIUMCA2Y0FE3FXIACT
arachidyl glucoside6JVW35JOOJIACT
bentoniteA3N5ZCN45CIACT
DOCOSANOL9G1OE216XYIACT
sodium hydroxide55X04QC32IIACT
EDETATE DISODIUM7FLD91C86KIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
erythorbic acid311332OII1IACT
polysorbate 207T1F30V5YHIACT
chlorphenesinI670DAL4SZIACT
titanium dioxide15FIX9V2JPIACT
phenoxyethanolHIE492ZZ3TIACT

Source Document#

Source XML · Source PDF

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 · 459 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCONCENTRATE / ORAL20 mgExact identifier — unii candidate
77 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SUSPENSION / INTRAVENOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARYADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KCREAM / VAGINAL0.05 %w/wExact identifier — unii candidate
32 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCREAM / VAGINAL3 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / INTRAMUSCULAR10 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
polysorbate 20POLYSORBATE 207T1F30V5YHTAMPON / VAGINAL64.8 mgExact identifier — unii candidate
28 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KOINTMENT / TOPICAL57 mgExact identifier — unii candidate
32 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTRAVENOUS456 mgExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ITABLET, EXTENDED RELEASE / ORAL13 mgExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / SUBCONJUNCTIVALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXTABLET, CHEWABLE / ORAL12 mgExact identifier — unii candidate
75 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPOINTMENT / TOPICAL5 %w/wExact identifier — unii candidate
40 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / NASAL25 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVERNOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, SUSPENSION / SOFT TISSUE1 mgExact identifier — unii candidate
77 equally ranked IID candidates
polysorbate 20POLYSORBATE 207T1F30V5YHINJECTION / SUBCUTANEOUSNAExact identifier — unii candidate
28 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXINJECTION / SUBCUTANEOUS450 mgExact identifier — unii candidate
75 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS78.36 mgExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / INTRATHECALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KLIQUID / ORAL0.5 mg/1mlExact identifier — unii candidate
77 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii candidate
75 equally ranked IID candidates
polysorbate 20POLYSORBATE 207T1F30V5YHINJECTION, POWDER, FOR SOLUTION / INTRAVENOUSNAExact identifier — unii candidate
28 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCAPSULE / ORAL3487 mgExact identifier — unii candidate
75 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / PERINEURALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ISUSPENSION, EXTENDED RELEASE / INTRADERMALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCREAM, AUGMENTED / TOPICAL2 mgExact identifier — unii candidate
77 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KTABLET / ORAL3 mgExact identifier — unii candidate
32 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSUSPENSION / OPHTHALMIC58 mgExact identifier — unii candidate
75 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPSUPPOSITORY, EXTENDED RELEASE / INTRAUTERINE1 mgExact identifier — unii candidate
40 equally ranked IID candidates
polysorbate 20POLYSORBATE 207T1F30V5YHSOLUTION / TOPICAL15 %w/wExact identifier — unii candidate
28 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION, CONCENTRATE / ORAL200 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION/ DROPS / OPHTHALMIC0.13 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ISUSPENSION/ DROPS / AURICULAR (OTIC)ADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSUSPENSION / ORAL26208 mgExact identifier — unii candidate
75 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR0.35 %w/vExact identifier — unii candidate
174 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXEMULSION / OPHTHALMIC3 mgExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / NASAL100 mg/100mlExact identifier — unii candidate
77 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / RETROBULBARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
polysorbate 20POLYSORBATE 207T1F30V5YHCREAM / TOPICAL108 mgExact identifier — unii candidate
28 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INTRAMUSCULAR78 mgExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ILIQUID / INTRAMUSCULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KINJECTION, POWDER, FOR SOLUTION / INTRAVENOUSNAExact identifier — unii candidate
32 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTRAVITREALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTRA-ARTERIAL176 mgExact identifier — unii candidate
174 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii candidate
75 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / PARENTERALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS6 mgExact identifier — unii candidate
77 equally ranked IID candidates
bentoniteBENTONITEA3N5ZCN45CSYSTEM / TRANSDERMAL9.86 mgExact identifier — unii candidate
11 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ISUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR5.4 mgExact identifier — unii candidate
174 equally ranked IID candidates
bentoniteBENTONITEA3N5ZCN45CPOWDER, DENTIFRICE / DENTAL0.05 mg/mgExact identifier — unii candidate
11 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / AURICULAR (OTIC)0.8 %w/wExact identifier — unii candidate
174 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KGEL / TRANSDERMAL1 mgExact identifier — unii candidate
77 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ICAPSULE / ORAL60 mgExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ITABLET, COATED / ORALNAExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / SUBCUTANEOUS6 mgExact identifier — unii candidate
77 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPCAPSULE, DELAYED RELEASE PELLETS / ORAL24 mgExact identifier — unii candidate
40 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / RESPIRATORY (INHALATION)43 mgExact identifier — unii candidate
77 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ICREAM / VAGINAL0.19 %w/wExact identifier — unii candidate
174 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
438aff74-9816-41f3-967b-0c02dc008179b0dd8248-424d-44cb-a037-f2d894c8ec3a2012-04-11WarningsExact identifier
spl id: 438aff74-9816-41f3-967b-0c02dc008179
spl set id: b0dd8248-424d-44cb-a037-f2d894c8ec3a

Reported adverse events (FAERS/openFDA)#

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