FDA.reportPublic FDA data

HELLO SUNDAY THE MINERAL LIP ONE NOURISHING LIP TINT SPF 45 BERRY BALMY

Manufacturer
Kao USA Inc.
Effective date
2026-01-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:31:40

Label at a glance#

ProductHELLO SUNDAY THE MINERAL LIP ONE NOURISHING LIP TINT SPF 45 BERRY BALMY
Active ingredientZINC OXIDE
Label structure8 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, pant...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

ZINC OXIDE 22.95%

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

CAPRYLIC/CAPRIC TRIGLYCERIDE, HELIANTHUS ANNUUS (SUNFLOWER) SEED WAX, JOJOBA ESTERS, PENTAERYTHRITYL TETRAISOSTEARATE, DIISOSTEARYL MALATE, BUTYLOCTYL SALICYLATE, BIS-DIGLYCERYL POLYACYLADIPATE-2, POLYGLYCERYL-4 ISOSTEARATE, SORBITAN OLIVATE, MORINGA OIL/HYDROGENATED MORINGA OIL ESTERS, POLYHYDROXYSTEARIC ACID, SILICA, EUPHORBIA CERIFERA (CANDELILLA) WAX, ISOSTEARIC ACID, LECITHIN, POLYGLYCERYL-3 POLYRICINOLEATE, SORBITAN ISOSTEARATE, ACACIA DECURRENS FLOWER WAX, DEHYDROACETIC ACID, FLAVOR/AROMA, HYALURONIC ACID, HYDROGENATED CASTOR OIL, IRON OXIDES, POLYGLYCERIN-3, PROPYLENE CARBONATE, RED 28 LAKE, RICINUS COMMUNIS (CASTOR) SEED OIL, STEARALKONIUM HECTORITE, TITANIUM DIOXIDE, TOCOPHEROL

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10596-001-01HELLO SUNDAY THE MINERAL LIP ONE NOURISHING LIP TINT SPF 45 BERRY BALMY1 in 1 CARTONSTICK12
10596-001-01HELLO SUNDAY THE MINERAL LIP ONE NOURISHING LIP TINT SPF 45 BERRY BALMY5.2 g in 1 TUBESTICK5.22

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10596-00110596-001-01

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
HELIANTHUS ANNUUS (SUNFLOWER) SEED WAX42DG15CHXVIACT
JOJOBA OIL, RANDOMIZED7F0EV20QYLIACT
SORBITAN OLIVATEMDL271E3GRIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
DEHYDROACETIC ACID2KAG279R6RIACT
HYDROGENATED CASTOR OILZF94AP8MEYIACT
STEARALKONIUM HECTORITEOLX698AH5PIACT
DIISOSTEARYL MALATEQBS8A3XZGQIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
POLYGLYCERYL-4 ISOSTEARATE820DPX33S7IACT
ISOSTEARIC ACIDX33R8U0062IACT
PENTAERYTHRITYL TETRAISOSTEARATE9D7IK5483FIACT
CI 45410767IP0Y5NHIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
BIS-DIGLYCERYL POLYACYLADIPATE-26L246LAM9TIACT
POLYGLYCERYL-3 PENTARICINOLEATE7Q0OK5DOT4IACT
ACACIA DECURRENS FLOWER WAXAU6XZE9IY9IACT
HYALURONIC ACIDS270N0TRQYIACT
FERRIC OXIDE RED1K09F3G675IACT
PROPYLENE CARBONATE8D08K3S51EIACT
CASTOR OILD5340Y2I9GIACT
TOCOPHEROLR0ZB2556P8IACT
ZINC OXIDESOI2LOH54ZACTIB
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
CANDELILLA WAXWL0328HX19IACT
LECITHIN, SUNFLOWER834K0WOS5GIACT
SORBITAN ISOSTEARATE01S2G2C1E4IACT
POLYGLYCERIN-34A0NCJ6RD6IACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT

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 MINERAL LIP ONE NOURISHING LIP TINT SPF 45 BERRY BALMYZINC OXIDEKao USA Inc.26bcb9cd-bfb5-998c-e063-6394a90ab9d62026-01-05WarningsExact identifier
ndc (package): 10596-001-01
ndc (product): 10596-001
ndc11 (package): 10596000101
spl id: 47ac56a4-f8ec-3780-e063-6294a90a0e4d
spl set id: 26bcb9cd-bfb5-998c-e063-6394a90ab9d6

Reported adverse events (FAERS/openFDA)#

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