FDA.reportPublic FDA data

NDC 70809-1235-01 - Sunscreen Lip Balm SPF 30 Cool Mint

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
70809-1235
Requested NDC
70809-1235-01
Package NDCs from labels
70809-1235-1, 70809-1235-2, 70809-1235-01
Manufacturer
USRX
Effective date
2025-04-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Sunscreen Lip Balm SPF 30 Cool Mint - USRXUSRX2025-04-16HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70809-1235-1Sunscreen Lip Balm SPF 30 Cool Mint4.8 g in 1 TUBESTICK4.82
70809-1235-2Sunscreen Lip Balm SPF 30 Cool Mint1 in 1 BOXSTICK12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70809-1235SUNSCREEN LIP BALM SPF 30 COOL MINT (AVOBENZONE 3%, HOMOSALATE 7%, OCTISALATE 4.5%, OCTOCRYLENE 9%) STICK [USRX]2Current NDC, 2 package rows20250515_3271ab14-3bf5-a24f-e063-6294a90a59bc.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 40 of 368 · 7,352 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VitaveraVITAVERAOncora Pharma, LLC058b1921-21da-49d9-b9c1-3f5636087aea2026-04-21Warnings, Adverse reactionsExact identifier
unii: 9E8X80D2L0
HYDRA SPF 34HOMOSALATE, OCTYL SALICYLATE, AVOBENZONEDrmtlgy, LLC31e41ed5-8498-4e2d-928a-c15ca99775e42026-04-21WarningsExact identifier
application number: M020
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
FORGESKINMINERAL TALLOW SUNSCREENGUANGZHOU KANGLIXIN BIOTECHNOLOGY CO.,LTD4fe913f4-b0be-dc53-e063-6294a90a363c2026-04-20WarningsExact identifier
application number: M020
ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUNSCREEN SPF50 BROAD SPECTRUMAVOBENZONE, HOMOSALATE, OCTISALATESEORIN COMPANY Co., Ltd.228dcd68-aaba-0451-e063-6394a90a8ad02026-04-20WarningsExact identifier
application number: M020
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
Biore Aqua Rich UVOCTOCRYLENE, OCTISALATE, AVOBENZENE, HOMOSALATEKAO USAf900db18-5fe2-1d74-e053-6394a90a3ca22026-04-20WarningsExact identifier
application number: M020
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
Biore UV Aqua RichOCTOCRYLENE, OCTISALATE, AVOBENZENE, HOMOSALATEKAO USA2bc23bb5-86bb-7915-e063-6394a90a9d722026-04-20WarningsExact identifier
application number: M020
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
ETUDE SunPrise Mild Airy Finish SunstickAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEETUDE CORPORATION25abc744-5b62-acb4-e063-6394a90af1102026-04-19WarningsExact identifier
application number: M020
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c7c399-b05e-2545-e053-2995a90ac6112026-04-18WarningsExact identifier
application number: M020
unii: G63QQF2NOX
unii: 4X49Y0596W
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c7c399-b060-2545-e053-2995a90ac6112026-04-18WarningsExact identifier
application number: M020
unii: G63QQF2NOX
unii: 4X49Y0596W
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c7d9f4-986f-70f7-e053-2a95a90a4f8a2026-04-18WarningsExact identifier
application number: M020
unii: G63QQF2NOX
unii: 4X49Y0596W
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c81845-afcb-18ac-e053-2a95a90abdbe2026-04-18WarningsExact identifier
application number: M020
unii: G63QQF2NOX
unii: 4X49Y0596W
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c83245-a40c-8f05-e053-2a95a90a05212026-04-18WarningsExact identifier
application number: M020
unii: G63QQF2NOX
unii: 4X49Y0596W
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c84047-fd3b-ea66-e053-2a95a90ae9aa2026-04-18WarningsExact identifier
application number: M020
unii: G63QQF2NOX
unii: 4X49Y0596W
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c623aa-3846-b7f4-e053-2995a90aecb52026-04-18WarningsExact identifier
application number: M020
unii: G63QQF2NOX
unii: 4X49Y0596W
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c585ff-88de-e29c-e053-2a95a90af4d42026-04-18WarningsExact identifier
application number: M020
unii: G63QQF2NOX
unii: 4X49Y0596W
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c852de-4c36-6d93-e053-2995a90aff612026-04-18WarningsExact identifier
application number: M020
unii: G63QQF2NOX
unii: 4X49Y0596W
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c86288-bb22-03b1-e053-2995a90a31612026-04-18WarningsExact identifier
application number: M020
unii: G63QQF2NOX
unii: 4X49Y0596W
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c8742f-1060-48bc-e053-2995a90a31c22026-04-18WarningsExact identifier
application number: M020
unii: G63QQF2NOX
unii: 4X49Y0596W
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c4eedc-12a0-6418-e053-2a95a90a55e72026-04-18WarningsExact identifier
application number: M020
unii: G63QQF2NOX
unii: 4X49Y0596W
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c8849a-6624-6987-e053-2a95a90a45462026-04-18WarningsExact identifier
application number: M020
unii: G63QQF2NOX
unii: 4X49Y0596W

Reported adverse events (FAERS/openFDA)#

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