FDA.reportPublic FDA data

SPF15 lip balm

Product NDC
82953-024
11-digit product format
829530024
Labeler code
82953
Product ID
82953-024_20e12204-99a2-423c-e063-6294a90a33d4
Type
HUMAN OTC DRUG
Nonproprietary name
octocrylene, octisalate
Dosage form
LIPSTICK
Route
TOPICAL
Labeler
Cosmuses Cosmetics (Ningbo) Co., Ltd.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-10-01
Substance
OCTOCRYLENE; OCTISALATE
Active strength
8; 4 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
SPF15 lip balm
Brand name suffix
01
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTOCRYLENE8 g/100g
OCTISALATE4 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5A68WGF6WMInternal UNII lookup
4X49Y0596WInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
20e122e2-09ad-63ad-e063-6294a90a83fcAvailable on FDA.report

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

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 95 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Coppertone Kids Sport Sunscreen SPF 100AVOBENZONE 3%, HOMOSALATE 15%, OCTINOXATE 2% OCTISALATE 5%, OCTOCRYLENE 10%, OXYBENZONE 6%Beiersdorf Incc068a6e7-260f-0766-e053-2995a90a422f2025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Suncreen SPF 50AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%Beiersdorf Inccc43f433-51ff-ed6a-e053-2a95a90ad3c52025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Mineral Sunscreen SPF 50ZINC OXIDEBeiersdorf Incb5bb6eb6-3356-e2a5-e053-2995a90aa6842025-12-31WarningsExact identifier
application number: M020
Coppertone Limited Edition Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%Beiersdorf Incccbf7795-e153-1a43-e053-2a95a90ad4b62025-12-31WarningsExact identifier
application number: M020
Eucerin Advanced Hydration SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBeiersdorf Inccd9cbdb4-42f1-3063-e053-2a95a90a08aa2025-12-31WarningsExact identifier
application number: M020
Eucerin Baby Sensitive Mineral SPF 50 SunscreenZINC OXIDEBeiersdorf Inccdb19c82-9845-eabc-e053-2a95a90a31f72025-12-31WarningsExact identifier
application number: M020
Eucerin Advance Hydration Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBeiersdorf Inccd61e4d7-776d-8d84-e053-2995a90a48192025-12-31WarningsExact identifier
application number: M020
Eucerin Oil-Control SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBeiersdorf Inccda04484-ba84-2276-e053-2a95a90a41c82025-12-31WarningsExact identifier
application number: M020
Coppertone Kids Sunscreen SPF 60AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc240dd76a-8f39-caec-e063-6294a90abbbc2025-12-31WarningsExact identifier
application number: M020
Coppertone Protect and Tan SPF 30AVOBENZONE 3%, HOMOSALATE 14%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Incd3994886-2ebe-a9d2-e053-2995a90aaf9a2025-12-31WarningsExact identifier
application number: M020
Coppertone Waterbabies Pure and Simple Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Incd3d471b8-7430-98b0-e053-2995a90aba4b2025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 60AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc241f78be-0d7f-c5ca-e063-6294a90a997a2025-12-31WarningsExact identifier
application number: M020
Coppertone Protect and Tan Sunscreen SPF 45AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdort Incd39a009d-1f33-88bb-e053-2a95a90a03a02025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 30AVOBENZONE 2%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 7%Beiersdorf Incd460d669-42df-46c0-e053-2a95a90ad77b2025-12-31WarningsExact identifier
application number: M020
Coppertone Tanning Sunscreen SPF 8AVOBENZONE 2%, HOMOSALATE 5%, OCTISALATE 4.5%, OCTOCRYLENE 3%Beiersdorf Incd370094c-3373-594b-e053-2a95a90a114a2025-12-31WarningsExact identifier
application number: M020
Coppertone Tanning Sunscreen SPF 15(TO DELIVER) AVOBENZONE 2%, OCTISALATE 4.5%, OCTOCRYLENE 7%Beiersdorf Inc0a5a35be-9e24-18dd-e063-6394a90a097f2025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%Beiersdorf Incd462081f-f082-5df2-e053-2995a90aa1d92025-12-31WarningsExact identifier
application number: M020
Coppertone Waterbabies Pure and Simple Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Incd3e66496-bc3c-d189-e053-2a95a90a06b62025-12-31WarningsExact identifier
application number: M020
Coppertone Kids Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%Beiersdorf Inc.c05388dc-4282-ee79-e053-2a95a90a376a2025-12-31WarningsExact identifier
application number: M020
Coppertone Glow Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Incb60dcbd1-42d0-646f-e053-2a95a90a497d2025-12-31WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82953-024-01829530024012.2 g in 1 CYLINDER (82953-024-01) 2.2 g2022-10-01NoNoCurrent
82953-024-02829530024024.5 g in 1 CYLINDER (82953-024-02) 4.5 g2022-10-01NoNoCurrent
82953-024-03829530024035 g in 1 CYLINDER (82953-024-03) 5 g2022-10-01NoNoCurrent
82953-024-04829530024045.5 g in 1 CYLINDER (82953-024-04) 5.5 g2022-10-01NoNoCurrent
82953-024-05829530024056.5 g in 1 CYLINDER (82953-024-05) 6.5 g2022-10-01NoNoCurrent
82953-024-06829530024067 g in 1 CYLINDER (82953-024-06) 7 g2022-10-01NoNoCurrent
82953-024-078295300240710 g in 1 CYLINDER (82953-024-07) 10 g2022-10-01NoNoCurrent
82953-024-088295300240812 g in 1 CYLINDER (82953-024-08) 12 g2022-10-01NoNoCurrent
82953-024-09829530024092 g in 1 CYLINDER (82953-024-09) 2 g2022-10-01NoNoCurrent
82953-024-1082953002410.9 g in 1 CYLINDER (82953-024-10) 2022-10-01NoNoCurrent