FDA.reportPublic FDA data

Hello Sunday The Invisible One Sunscreen Plus Primer SPF 50

Manufacturer
Kao USA Inc.
Effective date
2025-01-31
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:54:11

Label at a glance#

ProductHello Sunday The Invisible One Sunscreen Plus Primer 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 1 teaspoon’s worth), 15 minutes before sun exposure and as a last step in your skincare routine (before makeup). Reapply every 2 hours. Reapply: after 40 minutes of swimming or sweating immediately after towel drying at least every two hours Sun Protection Measures : Spending time in the sun increases your risk of skin cancer and early skin ageing. To decrease this risk, ...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

AVOBENZONE 3%
HOMOSALATE 7.3%
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 on dry skin (we recommend 1 teaspoon’s worth), 15 minutes before sun exposure and as a last step in your skincare routine (before makeup). Reapply every 2 hours.
  • Reapply:
  • after 40 minutes of swimming or sweating
  • immediately after towel drying
  • at least every two hours
  • 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

ACRYLATES CROSSPOLYMER, COCO-CAPRYLATE/CAPRATE, TRIHEPTANOIN, C9-12 ALKANE, BUTYLOCTYL SALICYLATE, DILINOLEIC ACID/BUTANEDIOL COPOLYMER, C12-15 ALKYL BENZOATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, VP/EICOSENE COPOLYMER, ARGANIA SPINOSA KERNEL OIL, SODIUM HYALURONATE, TOCOPHERYL ACETATE, GLYCINE SOJA (SOYBEAN) OIL, ORYZA SATIVA (RICE) GERM EXTRACT, ORYZA SATIVA (RICE) EXTRACT, TETRAHEXYLDECYL ASCORBATE, PONGAMIA GLABRA SEED OIL, BISABOLOL, PHYSALIS ANGULATA EXTRACT, DUNALIELLA SALINA EXTRACT, HAEMATOCOCCUS PLUVIALIS EXTRACT, TOCOPHEROL, CASTOR OIL/IPDI COPOLYMER, CAPRYLYL GLYCOL, DIETHYLHEXYL SYRINGYLIDENEMALONATE, ETHYLHEXYL PALMITATE, POLYGLYCERYL-3 DIISOSTEARATE, TRIHYDROXYSTEARIN, GLUCOMANNAN

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
124351b2-6dbf-42d0-9ea7-f0e299215f9aProduct name120210115
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
10596-801-012025-02-01C16284748780-12cef2736-a974-d83d-e063-dadaa90ab31fHello Sunday The Invisible One Sunscreen Plus Primer SPF 50

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10596-801-01Hello Sunday The Invisible One Sunscreen Plus Primer SPF 501 in 1 CARTONEMULSION13
10596-801-01Hello Sunday The Invisible One Sunscreen Plus Primer SPF 5050 mL in 1 TUBEEMULSION503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10596-801HELLO SUNDAY THE INVISIBLE ONE SUNSCREEN PLUS PRIMER SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) EMULSION [KAO USA INC.]3Current NDC, 2 package rows20250202_0c7ce5b9-5ab4-d845-e063-6394a90afa76.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
10596-80110596-801-01

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
OCTISALATE4X49Y0596WACTIB
TRIHEPTANOIN2P6O7CFW5KIACT
HYALURONATE SODIUMYSE9PPT4THIACT
RICE GERM7N2B70SFEZIACT
KARUM SEED OIL62160PU6FJIACT
TRIHYDROXYSTEARIN06YD7896S3IACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
HAEMATOCOCCUS PLUVIALIS31T0FF0472IACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
DILINOLEIC ACID/BUTANEDIOL COPOLYMER1F2S8T535OIACT
ARGAN OIL4V59G5UW9XIACT
TOCOPHEROLR0ZB2556P8IACT
DIETHYLHEXYL SYRINGYLIDENEMALONATE3V5U97P248IACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
VINYLPYRROLIDONE/EICOSENE COPOLYMER035MV9S1C3IACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
DUNALIELLA SALINAF4O1DKI9A6IACT
ETHYLHEXYL PALMITATE2865993309IACT
LEVOMENOL24WE03BX2TIACT
KONJAC MANNAN36W3E5TAMGIACT
PHYSALIS ANGULATA WHOLEW4TKW9D5GGIACT
CAPRYLYL GLYCOL00YIU5438UIACT
OCTOCRYLENE5A68WGF6WMACTIB
C9-12 ALKANE7J5R5W72QMIACT
POLYGLYCERYL-3 DIISOSTEARATE46P231IQV8IACT
COCO-CAPRYLATE/CAPRATE8D9H4QU99HIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
SOYBEAN OIL241ATL177AIACT
HOMOSALATEV06SV4M95SACTIB
AVOBENZONEG63QQF2NOXACTIB

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 Invisible One Sunscreen Plus Primer SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKao USA Inc.0c7ce5b9-5ab4-d845-e063-6394a90afa762025-01-31WarningsExact identifier
ndc (package): 10596-801-01
ndc (product): 10596-801
ndc11 (package): 10596080101
spl id: 2d0825f9-54a7-7081-e063-6394a90a37ae
spl set id: 0c7ce5b9-5ab4-d845-e063-6394a90afa76

Reported adverse events (FAERS/openFDA)#

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