FDA.reportPublic FDA data

SPF15 lip balm

Manufacturer
Cosmuses Cosmetics (Ningbo) Co., Ltd.
Effective date
2024-08-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:18:14

Label at a glance#

ProductSPF15 lip balm 01
Active ingredientOCTOCRYLENE, OCTISALATE
Label structure12 sections

Indications and uses

Helps prevent sunburn Higher SPF gives more sunburn protection

Dosage and administration

Apply liberally 15 minutes before sun exposure. Use a water resistant sunscreen if swimming or sweating. Reapply at least every 2 hours Children under 6 months: ask a doctor Sun protection Measures Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures includ...

Storage and handling

Protect from excessive heat and direct sun.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Octocrylene 8%

Octisalate 4%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn
  • Higher SPF gives more sunburn protection

warnings

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin.

OTC - WHEN USING SECTION

When using this 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

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

Spending time in the sun increases your risk of skin cancer and early skin aging. 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 10a.m.- 2 p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Paraffinum liquidum, Petrolatum, Ozokerite, Polyisobutene, Ethylhexyl Palmitate, Beeswax, Butyrospermum Parkii (Shea) Butter, Microcrystalline Wax, Phenoxyethanol, Fragrance, Tocopheryl Acetate

Other information

STORAGE AND HANDLING SECTION

Protect from excessive heat and direct sun.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

82953-02482953-024

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82953-024-01SPF15 lip balm012.2 g in 1 CYLINDERLIPSTICK2.21
82953-024-02SPF15 lip balm014.5 g in 1 CYLINDERLIPSTICK4.51
82953-024-03SPF15 lip balm015 g in 1 CYLINDERLIPSTICK51
82953-024-04SPF15 lip balm015.5 g in 1 CYLINDERLIPSTICK5.51
82953-024-05SPF15 lip balm016.5 g in 1 CYLINDERLIPSTICK6.51
82953-024-06SPF15 lip balm017 g in 1 CYLINDERLIPSTICK71
82953-024-07SPF15 lip balm0110 g in 1 CYLINDERLIPSTICK101
82953-024-08SPF15 lip balm0112 g in 1 CYLINDERLIPSTICK121
82953-024-09SPF15 lip balm012 g in 1 CYLINDERLIPSTICK21
82953-024-10SPF15 lip balm010.9 g in 1 CYLINDERLIPSTICK0.91

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82953-024SPF15 LIP BALM 01 (OCTOCRYLENE, OCTISALATE) LIPSTICK [COSMUSES COSMETICS (NINGBO) CO., LTD.]1Current NDC, 10 package rows20240831_20e122e2-09ad-63ad-e063-6294a90a83fc.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82953-02482953-024-01, 82953-024-02, 82953-024-03, 82953-024-04, 82953-024-05, 82953-024-06, 82953-024-07, 82953-024-08, 82953-024-09, 82953-024-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
FRAGRANCE 135765EM498GW35IACT
POLYISOBUTYLENE (1000 MW)5XB3A63Y52IACT
ETHYLHEXYL PALMITATE2865993309IACT
OCTOCRYLENE5A68WGF6WMACTIB
OCTISALATE4X49Y0596WACTIB
MINERAL OILT5L8T28FGPIACT
PETROLATUM4T6H12BN9UIACT
YELLOW WAX2ZA36H0S2VIACT
SHEA BUTTERK49155WL9YIACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
PHENOXYETHANOLHIE492ZZ3TIACT
.ALPHA.-TOCOPHEROL ACETATE, D-A7E6112E4NIACT
CERESINQ1LS2UJO3AIACT

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
SPF15 lip balm 01OCTOCRYLENE, OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.20e122e2-09ad-63ad-e063-6294a90a83fc2024-08-30WarningsExact identifier
ndc (package): 82953-024-06
ndc (package): 82953-024-05
ndc (package): 82953-024-04
ndc (package): 82953-024-03
ndc (package): 82953-024-02
ndc (package): 82953-024-01
ndc (package): 82953-024-08
ndc (package): 82953-024-09
ndc (package): 82953-024-07
ndc (package): 82953-024-10
ndc (product): 82953-024
ndc11 (package): 82953002403
ndc11 (package): 82953002401
ndc11 (package): 82953002410
ndc11 (package): 82953002406
ndc11 (package): 82953002402
ndc11 (package): 82953002404
ndc11 (package): 82953002409
ndc11 (package): 82953002405
ndc11 (package): 82953002408
ndc11 (package): 82953002407
spl id: 20e12204-99a2-423c-e063-6294a90a33d4
spl set id: 20e122e2-09ad-63ad-e063-6294a90a83fc

Reported adverse events (FAERS/openFDA)#

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