FDA.reportPublic FDA data

Hello Sunday The Everyday One Face Moisturiser SPF 50

Manufacturer
Kao USA Inc.
Effective date
2024-11-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:36:57

Label at a glance#

ProductHello Sunday The Everyday One Face Moisturiser SPF 50
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 on dry skin (we recommend 5 pumps, enough to cover your face, neck and ears), 15 minutes before sun exposure and as a last step in your skincare routine (before makeup). 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 ...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

AVOBENZONE 3%
HOMOSALATE 7%
OCTISALATE 5%
OCTOCRYLENE 10%

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 on dry skin (we recommend 5 pumps, enough to cover your face, neck and ears), 15 minutes before sun exposure and as a last step in your skincare routine (before makeup).
  • 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), C12-15 ALKYL BENZOATE, GLYCERIN, CETEARYL ALCOHOL, GLYCERYL STEARATE, SILICA, SODIUM HYALURONATE, GLYCINE SOJA (SOYBEAN) OIL, ACRYLATES/C12-22 ALKYL METHACRYLATE COPOLYMER, ETHYL FERULATE, TOCOPHERYL ACETATE, TETRAHEXYLDECYL ASCORBATE, ORYZA SATIVA (RICE) GERM EXTRACT, ORYZA SATIVA (RICE) EXTRACT, CAESALPINIA SPINOSA FRUIT POD EXTRACT, HELIANTHUS ANNUUS (SUNFLOWER) SPROUT EXTRACT, SODIUM PHYTATE, MALTODEXTRIN, MORINGA OLEIFERA SEED EXTRACT, HYDROXYACETOPHENONE, SODIUM STEAROYL GLUTAMATE, 1,2-HEXANEDIOL, CAPRYLYL GLYCOL, XANTHAN GUM, POLYGLYCERYL-3 DIISOSTEARATE, PENTYLENE GLYCOL, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, SODIUM HYDROXIDE

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
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10596-802-01Hello Sunday The Everyday One Face Moisturiser SPF 501 in 1 CARTONEMULSION12
10596-802-01Hello Sunday The Everyday One Face Moisturiser SPF 5050 mL in 1 BOTTLEEMULSION502
10596-802-02Hello Sunday The Everyday One Face Moisturiser SPF 501.5 mL in 1 PACKETEMULSION1.52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10596-802HELLO SUNDAY THE EVERYDAY ONE FACE MOISTURISER SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) EMULSION [KAO USA INC.]2Current NDC, 3 package rows20241115_0c7e1aa2-7054-435d-e063-6394a90a2d08.zip

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
10596-80210596-802-01, 10596-802-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
NameUNIIKind
MALTODEXTRIN7CVR7L4A2DIACT
MORINGA OLEIFERA SEEDTIX5482832IACT
OCTISALATE4X49Y0596WACTIB
WATER059QF0KO0RIACT
HYALURONATE SODIUMYSE9PPT4THIACT
RICE GERM7N2B70SFEZIACT
GLYCERINPDC6A3C0OXIACT
ETHYL FERULATE5B8915UELWIACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
CAESALPINIA SPINOSA FRUIT PODEXY4496LWDIACT
HELIANTHUS ANNUUS SPROUT4P26HG1S5WIACT
PHYTATE SODIUM88496G1ERLIACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
1,2-HEXANEDIOLTR046Y3K1GIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
XANTHAN GUMTTV12P4NEEIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S)8Z5ZAL5H3VIACT
CAPRYLYL GLYCOL00YIU5438UIACT
OCTOCRYLENE5A68WGF6WMACTIB
PENTYLENE GLYCOL50C1307PZGIACT
POLYGLYCERYL-3 DIISOSTEARATE46P231IQV8IACT
SODIUM HYDROXIDE55X04QC32IIACT
SOYBEAN OIL241ATL177AIACT
HOMOSALATEV06SV4M95SACTIB
AVOBENZONEG63QQF2NOXACTIB
GLYCERYL MONOSTEARATE230OU9XXE4IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT

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 Everyday One Face Moisturiser SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKao USA Inc.0c7e1aa2-7054-435d-e063-6394a90a2d082024-11-12WarningsExact identifier
ndc (package): 10596-802-02
ndc (package): 10596-802-01
ndc (product): 10596-802
ndc11 (package): 10596080201
ndc11 (package): 10596080202
spl id: 26ba9461-aa37-9d09-e063-6394a90a29ae
spl set id: 0c7e1aa2-7054-435d-e063-6394a90a2d08

Reported adverse events (FAERS/openFDA)#

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