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 119 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Complexion Correction Primer Sunscreen clearTITANIUM DIOXIDE, ZINC OXIDEMCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY357eee3c-1c21-5efb-e063-6294a90a4bb72025-12-15Exact identifier
application number: M020
Complexion Correction Tinted Primer SunscreenTITANIUM DIOXIDE, ZINC OXIDEMCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY357e75ec-473e-df76-e063-6294a90a70c72025-12-15Exact identifier
application number: M020
Complexion Correction Tinted Primer SunscreenTITANIUM DIOXIDE, ZINC OXIDEMCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY357f2f62-904a-2234-e063-6394a90aee722025-12-15Exact identifier
application number: M020
Superscreen Daytime Mineral SunscreenZINC OXIDEMCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY357f915a-bd77-350b-e063-6294a90ad27f2025-12-15Exact identifier
application number: M020
Complexion Correction Primer Sunscreen clearTITANIUM DIOXIDE, ZINC OXIDEMCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY357ff025-84ad-6d77-e063-6394a90aad952025-12-15Exact identifier
application number: M020
Complexion Correction Tinted Primer SunscreenTITANIUM DIOXIDE, ZINC OXIDEMCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY358021a2-235b-825b-e063-6394a90a76f52025-12-15Exact identifier
application number: M020
Superscreen Daytime Mineral SunscreenZINC OXIDEMCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY35805e66-18e6-0e45-e063-6294a90afe582025-12-15Exact identifier
application number: M020
Ultra Zinc Physical DefenseZINC OXIDEATLANTA DERMOTOLOGY VEIN & RESEARCH CENTER35474ac4-8a9d-6a84-e063-6394a90a9bad2025-12-15Exact identifier
application number: M020
Ultra Zinc Physical DefenseZINC OXIDEATLANTA DERMOTOLOGY VEIN & RESEARCH CENTER357e315e-8802-ad73-e063-6394a90a24952025-12-15Exact identifier
application number: M020
Tinted Physical DefenseTITANIUM DIOXIDE, ZINC OXIDEATLANTA DERMOTOLOGY VEIN & RESEARCH CENTER35477ed2-0875-58d5-e063-6294a90a3d5d2025-12-15Exact identifier
application number: M020
Anti Aging Daily ProtectionZINC OXIDELEVERRIER, KAMILA35465f21-8bcd-6e44-e063-6294a90a8e5f2025-12-15Exact identifier
application number: M020
Anti Aging Daily ProtectionZINC OXIDELEVERRIER, KAMILA3546d369-3435-b56a-e063-6294a90a08432025-12-15Exact identifier
application number: M020
Tinted Facial SunscreenTITANIUM DIOXIDE, ZINC OXIDEHELTON SKIN & LASER INSTITUTE35a97770-2db9-99aa-e063-6294a90a459a2025-12-15Exact identifier
application number: M020
Tinted Replenishing Daily ProtectionZINC OXIDEHELTON SKIN & LASER INSTITUTE35a9d07d-70e5-5eed-e063-6394a90aebaf2025-12-15Exact identifier
application number: M020
Non-Tinted Sports StickTITANIUM DIOXIDE, ZINC OXIDEHELTON SKIN & LASER INSTITUTE35aa833a-19a1-99e9-e063-6394a90a840f2025-12-15Exact identifier
application number: M020
Tinted Facial PrimerTITANIUM DIOXIDE, ZINC OXIDEBEE NATURALS36c3352e-fa51-19ad-e063-6394a90a591b2025-12-15Exact identifier
application number: M020
Luminous Tinted MoisturizingZINC OXIDESKIN BOSS L.L.C.35a8ae26-82eb-e4ca-e063-6394a90a00222025-12-15Exact identifier
application number: M020
Restore Tinted MoisturizingZINC OXIDESKIN BOSS L.L.C.35a8e92e-ced2-fdcd-e063-6294a90acedc2025-12-15Exact identifier
application number: M020
Velvet Tinted Moisturizing Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESKIN BOSS L.L.C.35a871dc-a707-9963-e063-6294a90a43962025-12-15Exact identifier
application number: M020
Velvet NT Moisturizing Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESKIN BOSS L.L.C.35a8508d-7069-c2d6-e063-6394a90a62192025-12-15Exact 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