FDA.reportPublic FDA data

The Mineral Lip One SPF 45 Nourishing Lip Tint Vanilla Cloud

Manufacturer
COSMAX USA, CORP
Effective date
2025-12-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:31:03

Label at a glance#

ProductThe Mineral Lip One SPF 45 Nourishing Lip Tint Vanilla Cloud
Active ingredientZINC OXIDE
Label structure8 sections

Indications and uses

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

Directions 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 sh...

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Zinc Oxide 22.95%

OTC - PURPOSE SECTION

Purpose

Sunscreen

USES

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Warnings

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Directions

  • 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 INGREDIENT SECTION

Inactive Ingredients

Caprylic/Capric Triglyceride, Helianthus Annuus (Sunflower) Seed Wax, Jojoba Esters, Pentaerythrityl Tetraisostearate, Butyloctyl Salicylate, Diisostearyl Malate, Bis-Diglyceryl Polyacyladipate-2, Sorbitan Olivate, Polyglyceryl-4 Isostearate, Moringa Oil/Hydrogenated Moringa Oil Esters, Polyhydroxystearic Acid, Silica, Euphorbia Cerifera (Candelilla) Wax, Isostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Sorbitan Isostearate, Stearalkonium Hectorite, Flavor, Iron Oxides (Ci 77491), Propylene Carbonate, Iron Oxides (Ci 77492), Polyglycerin-3, Acacia Decurrens Flower Wax, Iron Oxides (Ci 77499), Dehydroacetic Acid, Ricinus Communis (Castor) Seed Oil, Hyaluronic Acid, Hydrogenated Castor Oil, Tocopherol

QUESTIONS OR COMENTS

OTC - QUESTIONS SECTION

Questions or comments?

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HELLO SUNDAY THE MINERAL LIP ONE NOURISHING LIP TINT SPF 45 VANILLA CLOUD 5.2g/.18oz

CartridgeCartridgeLabelLabelCartonCarton

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68577-223-01The Mineral Lip One SPF 45 Nourishing Lip Tint Vanilla Cloud5.2 mL in 1 CARTRIDGELIPSTICK5.21
68577-223-01The Mineral Lip One SPF 45 Nourishing Lip Tint Vanilla Cloud1 in 1 CARTONLIPSTICK11

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68577-22368577-223-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYGLYCERYL-3 PENTARICINOLEATE7Q0OK5DOT4IACT
LECITHIN, SUNFLOWER834K0WOS5GIACT
EUPHORBIA CERIFERA (CANDELILLA) WAXWL0328HX19IACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
ISOSTEARIC ACIDX33R8U0062IACT
DEHYDROACETIC ACID2KAG279R6RIACT
RICINUS COMMUNIS (CASTOR) SEED OILD5340Y2I9GIACT
HYDROGENATED CASTOR OILZF94AP8MEYIACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
POLYGLYCERYL-4 ISOSTEARATE820DPX33S7IACT
STEARALKONIUM HECTORITEOLX698AH5PIACT
TOCOPHEROLR0ZB2556P8IACT
HYALURONIC ACIDS270N0TRQYIACT
CI 77499XM0M87F357IACT
SORBITAN ISOSTEARATE01S2G2C1E4IACT
ZINC OXIDESOI2LOH54ZACTIB
CI 774911K09F3G675IACT
POLYGLYCERIN-34A0NCJ6RD6IACT
JOJOBA OIL, RANDOMIZED7F0EV20QYLIACT
PENTAERYTHRITYL TETRAISOSTEARATE9D7IK5483FIACT
SORBITAN OLIVATEMDL271E3GRIACT
DIISOSTEARYL MALATEQBS8A3XZGQIACT
SILICAETJ7Z6XBU4IACT
PROPYLENE CARBONATE8D08K3S51EIACT
CI 77492EX438O2MRTIACT
ACACIA DECURRENS FLOWER WAXAU6XZE9IY9IACT
BIS-DIGLYCERYL POLYACYLADIPATE-26L246LAM9TIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT

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
57c4d5c1-d1e6-89a9-e063-6394a90a1375476d5d27-76ef-06cf-e063-6294a90ab2e42026-07-29WarningsExact identifier
spl set id: 476d5d27-76ef-06cf-e063-6294a90ab2e4

Reported adverse events (FAERS/openFDA)#

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