Hello Sunday The One For Your Lips Clear Lip Balm SPF 50

Manufacturer
Kao USA Inc.
Effective date
2025-11-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:16:34

Label at a glance#

ProductHello Sunday The One For Your Lips Clear Lip Balm SPF 50
Active ingredientOCTISALATE, AVOBENZONE, OCTOCRYLENE, HOMOSALATE
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 to lips before sun exposure. Reapply frequently Do not swallow 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...

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

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 to lips before sun exposure.
  • Reapply frequently
  • Do not swallow
  • 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

Other Information

OTHER SAFETY INFORMATION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

POLYISOBUTENE, CAPRYLIC/CAPRIC TRIGLYCERIDE, SILICA DIMETHYL SILYLATE, BUTYLOCTYL SALICYLATE, SQUALANE, DICAPRYLYL CARBONATE, OCTYLDODECANOL, BUTYROSPERMUM PARKII (SHEA) BUTTER, GLYCERYL BEHENATE, FRAGRANCE, SODIUM HYALURONATE, TOCOPHEROL, ORYZA SATIVA (RICE) EXTRACT, ORYZA SATIVA (RICE) GERM EXTRACT, SYNTHETIC WAX, STEARALKONIUM BENTONITE, PHYSALIS ANGULATA EXTRACT, 1,2-HEXANEDIOL, BISABOLOL, CAPRYLYL GLYCOL, ETHYLHEXYL PALMITATE, GLYCINE SOJA (SOYBEAN) OIL, PROPYLENE CARBONATE, POLYGLYCERYL-3 DIISOSTEARATE, TRIHYDROXYSTEARIN, GLUCOMANNAN, BENZYL BENZOATE.

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10596-806-01Hello Sunday The One For Your Lips Clear Lip Balm SPF 5015 mL in 1 TUBESTICK152
10596-806-01Hello Sunday The One For Your Lips Clear Lip Balm SPF 501 in 1 CARTONSTICK12

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10596-80610596-806-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

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 For Your Lips Clear Lip Balm SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKao USA Inc.0c92dfc3-782d-e11f-e063-6394a90a2f8a2025-11-17WarningsExact identifier
ndc (package): 10596-806-01
ndc (product): 10596-806
ndc11 (package): 10596080601
spl id: 43d0f364-238d-9fae-e063-6394a90a4777
spl set id: 0c92dfc3-782d-e11f-e063-6394a90a2f8a

Reported adverse events (FAERS/openFDA)#

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