FDA.reportPublic FDA data

INN BEAUTY SUN BALM SPF30 BROAD SPECTRUM LIP BALM - PINK

Manufacturer
COSMAX USA, CORPORATION
Effective date
2024-12-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:47:12

Label at a glance#

ProductINN BEAUTY SUN BALM SPF30 BROAD SPECTRUM LIP BALM - PINK
Active ingredientZINC OXIDE
Label structure8 sections

Indications and uses

Uses helps protect against sunburn and chapped lips

Dosage and administration

Directions apply generously and evenly 15 minutes before sun exposure reapply at least every 2 hours use a water resistant sunscreen if swimming or sweating Sun Protection Measures . Spending time increases your risk of skin cancer and early aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF of 15 or higher and other sun protection measures indluding: limit time in the sun, especiall...

Storage and handling

Other information protect this product from excessive heat and direct sun

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Zinc Oxide 13.5%

OTC - PURPOSE SECTION

Purpose

Sunscreen

USES

INDICATIONS & USAGE SECTION

Uses

  • helps protect against sunburn and chapped lips

WARNINGS SECTION

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

When using the product keep out of eyes. Rinse with water to remove.

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 product is swallowed, get medical help or contact a Poison Control center right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Directions

  • apply generously and evenly 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a water resistant sunscreen if swimming or sweating

Sun Protection Measures. Spending time increases your risk of skin cancer and early aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF of 15 or higher and other sun protection measures indluding:

  • 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: Ask a doctor

INACTIVE INGREDIENT SECTION

Inactive Ingredients:

Diisostearyl Malate, Polybutene, Hydrogenated Polyisobutene, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Microcrystalline Wax, Silica Dimethyl Silylate, Bis-Diglyceryl Polyacyladipate-2, Sorbitan Olivate, Isononyl Isononanoate, Squalane, Simmondsia Chinensis (Jojoba) Seed Oil, Mangifera Indica (Mango) Seed Butter, Butyrospermum Parkiii (Shea) Butter, Tetrahexyldecyl Ascorbate, Rosa Canina Fruit Oil, Bisabolol, Sorbitan Isostearate, Isostearic Acid, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, VP/Hexadecene Copolymer, Dehydroxyacetic Acid, Lecithin, Titanium Dioxide (CI 77891), Iron Oxides (CI 77492), Iron Oxides (CI 77491), Iron Oxides (CI 77499), Yellow 5 Lake (CI 19140), Red 7 Lake (CI 15850), Tocopherol, Menthone Glycerin Acetal, Flavor.

OTHER INFORMATION

STORAGE AND HANDLING SECTION

Other information

  • protect this product from excessive heat and direct sun

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

tubetubeCarton Side 1Carton Side 1Carton Side 2Carton Side 2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68577-191-00INN BEAUTY SUN BALM SPF30 BROAD SPECTRUM LIP BALM - PINK1 in 1 CARTONCREAM11
68577-191-00INN BEAUTY SUN BALM SPF30 BROAD SPECTRUM LIP BALM - PINK17 g in 1 TUBECREAM171

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68577-191INN BEAUTY SUN BALM SPF30 BROAD SPECTRUM LIP BALM - PINK (ZINC OXIDE) CREAM [COSMAX USA, CORPORATION]12 package rows20241222_29ae4e16-0ef0-8080-e063-6394a90a65da.zip

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
68577-19168577-191-00

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
ZINC OXIDESOI2LOH54ZACTIB
MICROCRYSTALLINE WAXXOF597Q3KYIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
SORBITAN OLIVATEMDL271E3GRIACT
MANGIFERA INDICA (MANGO) SEED BUTTER4OXD9M35X2IACT
HYDROGENATED POLYISOBUTENE (450 MW)7YR4ZFS62EIACT
BISABOLOL24WE03BX2TIACT
SILICA DIMETHYL SILYLATEEU2PSP0G0WIACT
TOCOPHEROLR0ZB2556P8IACT
IRON OXIDES1K09F3G675IACT
MENTHONE GLYCERIN ACETAL7QQ1EE6RCPIACT
POLYBUTENE (1400 MW)1NA5AO9GH7IACT
ISONONYL ISONONANOATES4V5BS6GCXIACT
SQUALANEGW89575KF9IACT
ISOSTEARIC ACIDX33R8U0062IACT
DIISOSTEARYL MALATEQBS8A3XZGQIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
BIS-DIGLYCERYL POLYACYLADIPATE-26L246LAM9TIACT
SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL724GKU717MIACT
POLYGLYCERYL-3 PENTARICINOLEATE7Q0OK5DOT4IACT
BUTYROSPERMUM PARKII (SHEA) BUTTERK49155WL9YIACT
ROSA CANINA FRUIT OILCR7307M3QZIACT
SORBITAN ISOSTEARATE01S2G2C1E4IACT
VP/HEXADECENE COPOLYMERKFR5QEN0N9IACT
DEHYDROACETIC ACID2KAG279R6RIACT

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
562089ca-9b53-e0a1-e063-6394a90ac71c29ae4e16-0ef0-8080-e063-6394a90a65da2026-07-08WarningsExact identifier
spl set id: 29ae4e16-0ef0-8080-e063-6394a90a65da

Reported adverse events (FAERS/openFDA)#

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