FDA.reportPublic FDA data

lip balm SPF15( CB400)

Manufacturer
Cosmuses Cosmetics (Ningbo) Co., Ltd.
Effective date
2025-03-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:58:03

Label at a glance#

Productlip balm SPF15( CB400) 01
Active ingredientOCTOCRYLENE, OCTISALATE
Label structure13 sections

Indications and uses

Helps prevent sunburn

Dosage and administration

Apply liberally 15minutes before sun exposure Use a water resistant sunscreen if swimming or sweating. Reapply at least every 2 hours. Children under 6 months of age: Ask a doctor.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Octocrylene 8%

Octisalate 4%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn

warnings

WARNINGS SECTION

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 - WHEN USING SECTION

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

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

  • Apply liberally 15minutes before sun exposure
  • Use a water resistant sunscreen if swimming or sweating.
  • Reapply at least every 2 hours.
  • Children under 6 months of age: Ask a doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Beeswax, Microcrystalline wax, Ozokerite wax, Mineral Oil, Butyrospermum Parkii (Shea) Butter, Petrolatum, Polyisobutene, Tocopherol, Phenoxyethanol, Fragrance

other information

OTHER SAFETY INFORMATION

Protect from excessive heat and direct sun.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

82953-04282953-042

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82953-042-01lip balm SPF15( CB400)014.5 g in 1 CYLINDERLIPSTICK4.51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82953-042LIP BALM SPF15( CB400) 01 (OCTOCRYLENE,OCTISALATE) LIPSTICK [COSMUSES COSMETICS (NINGBO) CO., LTD.]1Current NDC, 1 package rows20250330_316463e0-dc1f-e2ae-e063-6394a90a0c3c.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82953-04282953-042-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
PETROLATUM4T6H12BN9UIACT
MINERAL OILT5L8T28FGPIACT
BEESWAX2ZA36H0S2VIACT
CERESINQ1LS2UJO3AIACT
PHENOXYETHANOLHIE492ZZ3TIACT
OCTOCRYLENE5A68WGF6WMACTIB
OCTISALATE4X49Y0596WACTIB
FRAGRANCE 135765EM498GW35IACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
POLYISOBUTYLENE (1000 MW)5XB3A63Y52IACT
TOCOPHEROLR0ZB2556P8IACT
BUTYROSPERMUM PARKII (SHEA) BUTTERK49155WL9YIACT

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
lip balm SPF15( CB400) 01OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.316463e0-dc1f-e2ae-e063-6394a90a0c3c2025-03-28WarningsExact identifier
ndc (package): 82953-042-01
ndc (product): 82953-042
ndc11 (package): 82953004201
spl id: 31645ba5-1425-b61c-e063-6294a90a97ee
spl set id: 316463e0-dc1f-e2ae-e063-6394a90a0c3c

Reported adverse events (FAERS/openFDA)#

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