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 6 of 361 · 7,213 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Meraki Protective Mist SunscreenBROAD SPECTRUM SPF 30MERAKI MEDICAL SPA LLC59446224-0e97-ae2c-e063-6394a90a2a652026-08-17WarningsExact identifier
application number: M020
Sun Zapper - Acne Pure Zinc Sunscreen SPF50ZINC OXIDEVeganic SKN Limited3ee435a5-70fb-0c8a-e063-6394a90a650a2026-08-16WarningsExact identifier
application number: M020
Sun Zapper - Anti-ageing pure zinc sunscreen SPF30ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED3f1dc3b2-c289-5996-e063-6394a90ac6222026-08-16WarningsExact identifier
application number: M020
ISNTREE HYALURONIC ACID SENSITIVE SUNSCREENZINC OXIDEISNTREE Inc.58e38665-0bca-fb02-e063-6394a90ad62a2026-08-13WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Daily Face Sunscreen Broad Spectrum SPF 70AVOBENZONE, BEMOTRIZINOL, HOMOSALATE, OCTISALATEKenvue Brands LLC58d3d390-8b88-a6fe-e063-6394a90a9bf82026-08-12WarningsExact identifier
application number: M020
Neutrogena Clear Face Sunscreen Acne Prone Skin Broad Spectrum SPF 60AVOBENZONE, BEMOTRIZINOL, HOMOSALATE, OCTISALATEKenvue Brands LLC58d7a3e3-b7df-43ce-e063-6294a90a729c2026-08-12WarningsExact identifier
application number: M020
HEB 50 Marigold Scent SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.B.58dafa24-24d5-aeb4-e063-6394a90a3c252026-08-12WarningsExact identifier
application number: M020
TESALOVA Coconut SPF 30 Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONETesalova Viktoriia PMU LLC58dbb9f1-cfb3-62ac-e063-6394a90a61062026-08-12WarningsExact identifier
application number: M020
Elta MD Skincare UV Stick Broad Spectrum SPF50ZINC OXIDECP Skin Health Group, Inc58dd81db-46d4-d763-e063-6394a90abb0b2026-08-12WarningsExact identifier
application number: M020
Basin Coconut SPF 30 Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONERetail Concepts of Minnesota, Inc.4a8e93a6-dcf9-3687-e063-6394a90a73ac2026-08-12WarningsExact identifier
application number: M020
UV Skin Recovery SPF 50 Red CorrectingZINC OXIDECP Skin Health Group, Inc.26e63890-d1af-d171-e063-6394a90af8282026-08-12WarningsExact identifier
application number: M020
UV Skin Recovery SPF 50ZINC OXIDECP Skin Health Group, Inc.26d2683f-cfd5-50fd-e063-6394a90a75762026-08-12WarningsExact identifier
application number: M020
doTERRA Sun BodyMINERAL SUNSCREENdoTERRA International, LLC58dcc56f-f093-469c-e063-6394a90a60882026-08-12WarningsExact identifier
application number: M020
Sonage Protec Plus SPF 30 Mineral SunscreenZINC OXIDEASA Universal Inc. dba: Sonaged92fc1df-bbeb-592a-e053-2a95a90a69512026-08-12WarningsExact identifier
application number: M020
Colorescience Total Protection Body Shield GlowZINC OXIDEColorescience52e1d987-a4f8-195e-e063-6294a90a56292026-08-11WarningsExact identifier
application number: M020
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DR. SAMRAO'S OFFICE58b2ca35-11ed-d848-e063-6294a90a5b372026-08-11WarningsExact identifier
application number: M020
Ciele Tint and ProtectZINC OXIDECiele0162d9c9-07fa-9210-e063-6294a90aa6872026-08-11WarningsExact identifier
application number: M020
NeoStrata Skin Active Matrix Support SPF 30AVOBENZONE, OCTINOXATE, AND OCTISALATENeoStrata Company Inc.8e4b9c08-b906-4c5f-a243-55838ae28b902026-08-10WarningsExact identifier
application number: M020
Sunscreen for Kids SPF 50AVOBENZONE, HOMOSALATE, OCTISALATEThe Kroger Co.1c7cd904-ffff-48aa-91bd-cc978946b36a2026-08-10Warnings, Adverse reactionsExact identifier
application number: M020
Sport Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATEThe Kroger Co.22aa46af-5d0f-4256-8f45-be06f66275612026-08-10WarningsExact 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