FDA.reportPublic FDA data

Hello Sunday The One Thats a Serum Hydrating Serum SPF 45

Manufacturer
Kao USA Inc.
Effective date
2025-01-31
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:54:11

Label at a glance#

ProductHello Sunday The One Thats a Serum Hydrating Serum SPF 45
Active ingredientOCTISALATE, OCTOCRYLENE, HOMOSALATE, AVOBENZONE
Label structure9 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 ageing caused by the sun.

Dosage and administration

Apply generously (2 pipettes) to clean, dry skin as the last step of your skincare routine. Apply right after (or instead of) your daily moisturiser and before makeup. Appy 15 minutes before sun exposure. Reapply at least every 2 hours. Use a water resistant sunscreen if swimming or sweating Sun Protection Measures : Spending time in the sun increases your risk of skin cancer and early skin ageing. To decrease thi...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

AVOBENZONE 3%
HOMOSALATE 7%
OCTISALATE 5%
OCTOCRYLENE 9%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

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 ageing caused by the sun.

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin

Stop use and ask a doctor if

OTC - STOP USE SECTION

rash occurs

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply generously (2 pipettes) to clean, dry skin as the last step of your skincare routine. Apply right after (or instead of) your daily moisturiser and before makeup. Appy 15 minutes before sun exposure.
  • Reapply at least every 2 hours.
  • Use a water resistant sunscreen if swimming or sweating
  • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin ageing. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value 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-sleeved shirts, pants, hats, and sunglasses
  • Children under 6 months of age: Ask a doctor.

Other Information

OTHER SAFETY INFORMATION

  • protect the product in this container from excessive heat and direct sun.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

WATER (AQUA), GLYCERIN, BUTYLOCTYL SALICYLATE, C12-15 ALKYL BENZOATE, SILICA, PONGAMIA GLABRA SEED OIL, UNDECANE, SODIUM HYALURONATE, GLYCINE SOJA (SOYBEAN) SEED EXTRACT, GLYCINE SOJA (SOYBEAN) OIL, PYRUS MALUS (APPLE) FRUIT EXTRACT, PONGAMIA PINNATA SEED EXTRACT, TOCOPHEROL, ORYZA SATIVA (RICE) GERM EXTRACT, ORYZA SATIVA (RICE) EXTRACT, TETRAHEXYLDECYL ASCORBATE, DUNALIELLA SALINA EXTRACT, HAEMATOCOCCUS PLUVIALIS EXTRACT, CAESALPINIA SPINOSA FRUIT POD EXTRACT, HELIANTHUS ANNUUS (SUNFLOWER) SPROUT EXTRACT, FRUCTOSE, GLUCOSE, TRIDECANE, ETHYL FERULATE, POLYGLYCERYL-4 LAURATE, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, HYDROXYACETOPHENONE, POLYGLYCERYL-6 LAURATE, ARACHIDYL ALCOHOL, CELLULOSE GUM, POLYGLYCERYL-3 DIISOSTEARATE, BEHENYL ALCOHOL, SODIUM PHYTATE, ARACHIDYL GLUCOSIDE, MALTODEXTRIN, SODIUM DILAURAMIDOGLUTAMIDE LYSINE, POLYSORBATE 60, SORBITAN ISOSTEARATE, INULIN, XANTHAN GUM, CELLULOSE, PHENOXYETHANOL, CITRIC ACID

Questions or comments?

OTC - QUESTIONS SECTION

1-888-426-0695
Monday-Friday, 9 a.m. - 5 p.m. EST

Product Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10596-803-012025-02-01C16284748780-12cef2736-87a8-d83d-e063-dadaa90ab31fHello Sunday The One That's a Serum Hydrating Serum SPF 45

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10596-803-01Hello Sunday The One Thats a Serum Hydrating Serum SPF 451 in 1 CARTONEMULSION12
10596-803-01Hello Sunday The One Thats a Serum Hydrating Serum SPF 4530 mL in 1 BOTTLEEMULSION302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10596-803HELLO SUNDAY THE ONE THATS A SERUM HYDRATING SERUM SPF 45 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) EMULSION [KAO USA INC.]2Current NDC, 2 package rows20250202_0c913096-c000-4336-e063-6394a90a560c.zip

Products#

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

DailyMed product names page 1 of 2 · 48 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10596-80310596-803-01

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 46 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYSORBATE 60CAL22UVI4MIACT
ANHYDROUS DEXTROSE5SL0G7R0OKIACT
POLYGLYCERYL-4 LAURATE82V7NG3DYTIACT
SORBITAN ISOSTEARATE01S2G2C1E4IACT
HYALURONATE SODIUMYSE9PPT4THIACT
ARACHIDYL GLUCOSIDE6JVW35JOOJIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
MALTODEXTRIN7CVR7L4A2DIACT
OCTISALATE4X49Y0596WACTIB
WATER059QF0KO0RIACT
RICE GERM7N2B70SFEZIACT
GLYCERINPDC6A3C0OXIACT
ETHYL FERULATE5B8915UELWIACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
CAESALPINIA SPINOSA FRUIT PODEXY4496LWDIACT
HELIANTHUS ANNUUS SPROUT4P26HG1S5WIACT
PHYTATE SODIUM88496G1ERLIACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
KARUM SEED OIL62160PU6FJIACT
UNDECANEJV0QT00NUEIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
XANTHAN GUMTTV12P4NEEIACT
SOYBEANL7HT8F1ZODIACT
APPLEB423VGH5S9IACT
PONGAMIA PINNATA SEEDC2BRV53B1VIACT
OCTOCRYLENE5A68WGF6WMACTIB
TOCOPHEROLR0ZB2556P8IACT
POLYGLYCERYL-3 DIISOSTEARATE46P231IQV8IACT
DUNALIELLA SALINAF4O1DKI9A6IACT
SOYBEAN OIL241ATL177AIACT
HOMOSALATEV06SV4M95SACTIB
AVOBENZONEG63QQF2NOXACTIB
HAEMATOCOCCUS PLUVIALIS31T0FF0472IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
FRUCTOSE6YSS42VSEVIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
POWDERED CELLULOSESMD1X3XO9MIACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)86FQE96TZ4IACT
POLYGLYCERYL-6 LAURATEQ48X4BL3TVIACT
INULINJOS53KRJ01IACT

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
Hello Sunday The One Thats a Serum Hydrating Serum SPF 45AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKao USA Inc.0c913096-c000-4336-e063-6394a90a560c2025-01-31WarningsExact identifier
ndc (package): 10596-803-01
ndc (product): 10596-803
ndc11 (package): 10596080301
spl id: 2d08374b-a204-f33b-e063-6294a90a0948
spl set id: 0c913096-c000-4336-e063-6394a90a560c

Reported adverse events (FAERS/openFDA)#

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