Home NDC 82953-042 lip balm SPF15( CB400)
Product NDC 82953-042
11-digit product format 829530042
Labeler code 82953
Product ID 82953-042_31645ba5-1425-b61c-e063-6294a90a97ee
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 2025-03-27
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 lip balm SPF15( CB400)
Brand name suffix 01
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTOCRYLENE 8 g/100g OCTISALATE 4 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5A68WGF6WM Internal UNII lookup 4X49Y0596W Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 82953-042-01 lip balm SPF15( CB400)01 4.5 g in 1 CYLINDER LIPSTICK 4.5 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82953-042 LIP BALM SPF15( CB400) 01 (OCTOCRYLENE,OCTISALATE) LIPSTICK [COSMUSES COSMETICS (NINGBO) CO., LTD.] 1 Current NDC, 1 package rows 20250330_316463e0-dc1f-e2ae-e063-6394a90a0c3c.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 26 of 357 · 7,139 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 82953-042-01 82953004201 4.5 g in 1 CYLINDER (82953-042-01) 4.5 g 2025-03-27 No No Current