FDA.reportPublic FDA data

PHELITYL DAY SPF 15

Manufacturer
PML NYC, LLC
Effective date
2026-04-15
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:54:05

Label at a glance#

ProductPHELITYL DAY SPF 15
Active ingredientOCTINOXATE, AVOBENZONE
Label structure11 sections

Indications and 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

Dosage and administration

Apply liberally 15 minutes before sun exposure reapply: after 40 minutes of swimming or sweating immediately after towel drying 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 a broad spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, ...

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 2%,

Octinoxate 5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

OTC - WHEN USING 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

WARNINGS SECTION

  • 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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure
  • reapply: after 40 minutes of swimming or sweating
  • immediately after towel drying
  • 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 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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Glyceryl Stearate, Butylene Glycol, Cetyl Alcohol, Cyclopentasiloxane, C12-15 Alkyl Benzoate, Octyldodecyl Neopentanoate, Silica, Butyrospermum Parkii (Shea) Butter, Emu Oil, Glycerin, PEG-100 Stearate, Polyglyceryl-3 Laurate, Taraktogenos Kurzii Seed Oil, Aloe Barbadensis Leaf Extract, Anthemis Nobilis Flower Extract, Camellia Sinensis Leaf Extract, Panax Ginseng Root Extract, Allantoin, Carbomer, Ceteth-20, Disodium EDTA, Ethylhexylglycerin, O-Cymen-5-Ol, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Fragrance, Steareth-2, Steareth-20, Triethanolamine, Phenoxyethanol.

Other information

OTHER SAFETY INFORMATION

  • protect this product from excessive heat and direct sun

INDICATIONS & USAGE SECTION

Stop use and ask a doctor if rash occurs.

RECENT MAJOR CHANGES SECTION

dosage & admin update

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.

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PHELITYL DAY SPF 15PHELITYL DAY SPF 15

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

Products#

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

DailyMed product names page 1 of 1 · 34 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59735-47559735-475-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 33 matching rows.

Name, UNII, Kind table
NameUNIIKind
CETYL ALCOHOL936JST6JCNIACT
CYCLOMETHICONE 50THT5PCI0RIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SHEA BUTTERK49155WL9YIACT
EMU OIL344821WD61IACT
GLYCERINPDC6A3C0OXIACT
PEG-100 STEARATEYD01N1999RIACT
MYRISTYL ALCOHOLV42034O9PUIACT
COCO GLUCOSIDEICS790225BIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
OCTINOXATE4Y5P7MUD51ACTIB
CETETH-20I835H2IHHXIACT
AVOBENZONEG63QQF2NOXACTIB
WATER059QF0KO0RIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
DIMETHICONE92RU3N3Y1OIACT
HYDNOCARPUS KURZII SEED OILN757YEZ18QIACT
ALOE VERA LEAFZY81Z83H0XIACT
CHAMAEMELUM NOBILE FLOWERO2T154T6OGIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
ASIAN GINSENGCUQ3A77YXIIACT
ALLANTOIN344S277G0ZIACT
EDETATE DISODIUM7FLD91C86KIACT
STEARETH-20L0Q8IK9E08IACT
TROLAMINE9O3K93S3TKIACT
PHENOXYETHANOLHIE492ZZ3TIACT
O-CYMEN-5-OLH41B6Q1I9LIACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
STEARETH-2V56DFE46J5IACT

Source Document#

Source XML

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
PHELITYL DAY SPF 15PHELITYL DAY SPF 15PML NYC, LLCea9d33d9-6f9f-0a66-e053-2a95a90abd422026-04-15WarningsExact identifier
ndc (package): 59735-475-01
ndc (product): 59735-475
ndc11 (package): 59735047501
spl id: 4f84c06a-ed67-e186-e063-6394a90ac546
spl set id: ea9d33d9-6f9f-0a66-e053-2a95a90abd42

Reported adverse events (FAERS/openFDA)#

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