FDA.reportPublic FDA data

SPF15 natural lip balm

Manufacturer
Cosmuses Cosmetics (Ningbo) Co., Ltd.
Effective date
2024-12-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:43:55

Label at a glance#

ProductSPF15 natural lip balm 01
Active ingredientOCTOCRYLENE, HOMOSALATE, AVOBENZONE, OCTISALATE
Label structure9 sections

Indications and uses

Helps prevent sunburn Higher SPF giwes more sunburn protection

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. Sun Protection Measures Spending time in the sun increases your risk of skin cancer and early skin aging. To decreases this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measure...

Storage and handling

Protect this product from excessive heat and direct sun

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 2%

Homosalate 5%

Octocrylene 3%

Octisalate 3%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn
  • Higher SPF giwes more sunburn protection

Warnings

WARNINGS SECTION

For external use only

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 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.
  • Sun Protection Measures

Spending time in the sun increases your risk of skin cancer and early skin aging.

To decreases 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.- 2p.m.
  • wear long-sleeve shirts, pants, hats and sunglasses

Inactive ingredients

INACTIVE INGREDIENT SECTION

Mineral Oil, Beeswax, Ethylhexyl Palmitate, Ozokerite, Cocos Nucifera (Coconut) Oil,Olea Europaea (Olive) Fruit Oil,Polyisobutene, Butyrospermum Parkii (Shea) Butter, Synthetic Wax, Phenoxyethanol,Fragrance, BHT

Other information

STORAGE AND HANDLING SECTION

Protect this product from excessive heat and direct sun

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

82953-02882953-028

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82953-028-01SPF15 natural lip balm014.5 g in 1 CYLINDERLIPSTICK4.51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82953-028SPF15 NATURAL LIP BALM 01 (AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE) LIPSTICK [COSMUSES COSMETICS (NINGBO) CO., LTD.]1Current NDC, 1 package rows20241218_295f2a15-19fa-011f-e063-6394a90aea7b.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82953-02882953-028-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
BUTYROSPERMUM PARKII (SHEA) BUTTERK49155WL9YIACT
BHT1P9D0Z171KIACT
MINERAL OILT5L8T28FGPIACT
BEESWAX2ZA36H0S2VIACT
ETHYLHEXYL PALMITATE2865993309IACT
CERESINQ1LS2UJO3AIACT
PHENOXYETHANOLHIE492ZZ3TIACT
OCTOCRYLENE5A68WGF6WMACTIB
HOMOSALATEV06SV4M95SACTIB
AVOBENZONEG63QQF2NOXACTIB
OCTISALATE4X49Y0596WACTIB
SYNTHETIC WAX (1800 MW)248P1AUJ90IACT
POLYISOBUTYLENE (1000 MW)5XB3A63Y52IACT
COCOS NUCIFERA (COCONUT) OILQ9L0O73W7LIACT
OLEA EUROPAEA FRUIT VOLATILE OIL8E7358CX1JIACT
FRAGRANCE 135765EM498GW35IACT

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 natural lip balm 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.295f2a15-19fa-011f-e063-6394a90aea7b2024-12-16WarningsExact identifier
ndc (package): 82953-028-01
ndc (product): 82953-028
ndc11 (package): 82953002801
spl id: 295f26eb-f892-f374-e063-6294a90aafc7
spl set id: 295f2a15-19fa-011f-e063-6394a90aea7b

Reported adverse events (FAERS/openFDA)#

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