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 188 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 6ENSULIZOLE,HOMOSALATE ,OCTINOXATE ,TITANIUM DIOXIDEHangzhou Jingshen Trading Co., Ltd.3e069cb2-c4c5-abf5-e063-6394a90a56b02025-09-06WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 2C LightZINC OXIDEDolce & Gabbana Beauty S.R.L761ce50c-2bf5-4ed0-91ac-9c47f8790ddb2025-09-05WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 3W LightZINC OXIDEDolce & Gabbana Beauty S.R.L2781b921-eb0d-4270-addf-47301577b28c2025-09-05WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 5N LightZINC OXIDEDolce & Gabbana Beauty S.R.L893434a1-72b8-4f0f-bfaa-2c9d775d7e272025-09-05WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 7N LightZINC OXIDEDolce & Gabbana Beauty S.R.L199d97a2-d32b-45ab-a43d-30522b0ca5962025-09-05WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 10N Light MediumZINC OXIDEDolce & Gabbana Beauty S.R.L638eafb5-08a8-425f-893f-d6609b868e2b2025-09-05WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 9C Light MediumZINC OXIDEDolce & Gabbana Beauty S.R.L41fd80a9-2c6f-4f3e-a37d-e781965ddc552025-09-05WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 11W Light MediumZINC OXIDEDolce & Gabbana Beauty S.R.L50bac9fb-5b81-4cdd-9eae-ec9530fc46c32025-09-05WarningsExact identifier
application number: M020
Jack Black L.L.C.AVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUMJack Black L.L.C.3e0eb291-6bda-2f26-e063-6294a90ac4662025-09-05WarningsExact identifier
application number: M020
Jack BlackAVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUMJack Black L.L.C.3d5fafb9-62c9-ec69-e063-6394a90af8b92025-09-05WarningsExact identifier
application number: M020
Jack BlackAVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUMJack Black L.L.C.3e0f655e-6100-f1dd-e063-6394a90af7b72025-09-05WarningsExact identifier
application number: M020
Truskin SPF 30 Mineral Sunscreen Facial SerumZINC OXIDEAllure Labs3e13299f-8d5d-373b-e063-6394a90ab2562025-09-05WarningsExact identifier
application number: M020
PowderTITANIUM DIOXIDEOxygen Development LLC08b52f29-c1a0-c673-e063-6294a90a9a7a2025-09-05WarningsExact identifier
application number: M020
PowderTITANIUM DIOXIDEOxygen Development LLC08b8003f-40be-3380-e063-6294a90a4f6b2025-09-05WarningsExact identifier
application number: M020
MAYDAY Everyday Sunscreen SPF 30ZINC OXIDEOmniche Consumer Products Co.3f53fb40-6347-46b0-979c-3522d99481982025-09-04WarningsExact identifier
application number: M020
PHOFAY Matte Sunscreen Liquid Foundation SPF 30, 1ENSULIZOLE, HOMOSALATE, OCTINOXATE, TITANIUM DIOXIDEHangzhou Jingshen Trading Co., Ltd.18130858-429c-4ed4-a75b-5bc0144812502025-09-04WarningsExact identifier
application number: M020
Introstem PrismaStem Face Shield CreamOCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE AND AVOBENZONEInnovation Brands Inc.dd91374a-e3fc-42f1-a660-86b32a0cc8b82025-09-04WarningsExact identifier
application number: M020
MEDICUBE COLLAGEN GLOW SUNSCREENHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEAPR US INC34fae072-536c-ad41-e063-6394a90af0af2025-09-03WarningsExact identifier
application number: M020
Basin Sugar Plum SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc.3de75cec-955e-4b3a-e063-6394a90a15432025-09-03WarningsExact identifier
application number: M020
Basin Mint SPF 30 Broad Spectrum Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONERetail Concepts of Minnesota, Inc.3de7d21b-4f88-d80c-e063-6394a90a8e4c2025-09-03WarningsExact 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