FDA.reportPublic FDA data

PHELITYL DAY SPF 15

Product NDC
59735-475
11-digit product format
597350475
Labeler code
59735
Product ID
59735-475_4f84c06a-ed67-e186-e063-6394a90ac546
Type
HUMAN OTC DRUG
Nonproprietary name
PHELITYL DAY SPF 15
Dosage form
CREAM
Route
TOPICAL
Labeler
PML NYC, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-04-10
Substance
OCTINOXATE; AVOBENZONE
Active strength
5; 2 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
PHELITYL DAY SPF 15
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTINOXATE5 g/100g
AVOBENZONE2 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4Y5P7MUD51Internal UNII lookup
G63QQF2NOXInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ea9d33d9-6f9f-0a66-e053-2a95a90abd42Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59735-475-01PHELITYL DAY SPF 151 in 1 CARTONCREAM13
59735-475-01PHELITYL DAY SPF 1590 g in 1 JARCREAM903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59735-475PHELITYL DAY SPF 15 CREAM [MANA PRODUCTS, INC.]2Current NDC, Legacy NDC, 2 package rows20240104_ea9d33d9-6f9f-0a66-e053-2a95a90abd42.zip

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 120 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEESTHETICS BY RIKI LLC387d5194-bc12-68c1-e063-6394a90ab1522025-12-15Exact identifier
application number: M020
Tinted Mineral Sun ProtectantTITANIUM DIOXIDE, ZINC OXIDEPANDA PAMPERING LLC387c23c2-a9f0-f484-e063-6394a90a41042025-12-15Exact identifier
application number: M020
Tinted Mineral Sun ProtectantTITANIUM DIOXIDE, ZINC OXIDEPANDA PAMPERING LLC387be96f-8cda-ce02-e063-6394a90abea52025-12-15Exact identifier
application number: M020
Serum Lightly TintedZINC OXIDEPANDA PAMPERING LLC387c593b-c65b-62b5-e063-6294a90ac4c22025-12-15Exact identifier
application number: M020
Serum Lightly TintedZINC OXIDEPANDA PAMPERING LLC387c9167-638c-1e30-e063-6394a90a93742025-12-15Exact identifier
application number: M020
REJUVN8TITANIUM DIOXIDE, ZINC OXIDEFLEUR DE VIE LLC37ede476-43b6-a7c8-e063-6294a90a3e8f2025-12-15Exact identifier
application number: M020
REJUVN8TITANIUM DIOXIDE, ZINC OXIDEFLEUR DE VIE LLC37efa5e1-e88e-d251-e063-6394a90a93712025-12-15Exact identifier
application number: M020
Non-Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDETHE BEAUTY ROOM OC INC3dd330bf-92e4-3664-e063-6294a90a04752025-12-15WarningsExact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDETHE BEAUTY ROOM OC INC3dd37dd1-fd43-7af4-e063-6394a90ae3a02025-12-15WarningsExact identifier
application number: M020
Non-Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDETHE BEAUTY ROOM OC INC3dd3dcab-e9fb-0ef5-e063-6394a90acef12025-12-15WarningsExact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDETHE BEAUTY ROOM OC INC3dd40a6a-d52e-ab87-e063-6294a90a966e2025-12-15WarningsExact identifier
application number: M020
20 Zinc Oxide Non-Tinted Mineral SunscreenZINC OXIDEAGELESS SKINCARE INC3766e6c0-8976-509d-e063-6394a90af00f2025-12-15Exact identifier
application number: M020
20 Zinc Oxide Tinted Mineral SunscreenZINC OXIDEAGELESS SKINCARE INC3766b00f-ceda-a6f9-e063-6294a90aff5d2025-12-15Exact identifier
application number: M020
Mattifying Skin PrimerTITANIUM DIOXIDE, ZINC OXIDESKIN MAVEN37662032-2842-1982-e063-6294a90a49a02025-12-15Exact identifier
application number: M020
Moisturizing Face and Body SPFZINC OXIDESKIN MAVEN376645ee-7ea8-e738-e063-6394a90a119b2025-12-15Exact identifier
application number: M020
Mermaid Glow And Go Non Tinted Mineral SunscreenZINC OXIDEMermaid Glow LLC3985a298-fe0b-c296-e063-6294a90ab6c02025-12-15Exact identifier
application number: M020
Mermaid Glow And Go Non Tinted Mineral SunscreenZINC OXIDEMermaid Glow LLC39856675-c110-a7a7-e063-6294a90ac6af2025-12-15Exact identifier
application number: M020
Bio H Plus Daily Defense And RevitalizeZINC OXIDEBIOHEALTH PLUS LLC3764f723-cc7a-2128-e063-6294a90ac8942025-12-15Exact identifier
application number: M020
Extreme Protection Non TintedZINC OXIDEBIOHEALTH PLUS LLC37656077-5185-817a-e063-6394a90adf5a2025-12-15Exact identifier
application number: M020
Deluxe Lip ProtectionTITANIUM DIOXIDE, ZINC OXIDEBIOHEALTH PLUS LLC37657895-5fec-82d0-e063-6294a90acf672025-12-15Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59735-475-01597350475011 JAR in 1 CARTON (59735-475-01) / 90 g in 1 JAR1 jar2013-04-100000-00-00NoNoCurrent