FDA.reportPublic FDA data

NDC 76261-127-01 - Hydrating Lip Balm SPF 15 sunscreen ASAP

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
76261-127
Requested NDC
76261-127-01
Package NDCs from labels
76261-127-01, 76261-127-02
Manufacturer
AUSTRALIAN SKIN PRODUCTS PTY LTD | Natural Beauty Care Pty Ltd
Effective date
2014-08-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
AVOBENZONE - AUSTRALIAN SKIN PRODUCTS PTY LTD | Natural Beauty Care Pty LtdAUSTRALIAN SKIN PRODUCTS PTY LTD | Natural Beauty Care Pty Ltd2014-08-07HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76261-127-022019-11-27C16284748780-19855e2a2-3e31-60a7-e053-dbdaa90a05bdhydrating lip balm SPF 15 Sunscreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76261-127-01Hydrating Lip Balm SPF 15 sunscreenASAP10 mL in 1 TUBEGEL101
76261-127-02Hydrating Lip Balm SPF 15 sunscreenASAP1 in 1 CARTONGEL11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76261-127HYDRATING LIP BALM SPF 15 SUNSCREEN ASAP (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE) GEL [AUSTRALIAN SKIN PRODUCTS PTY LTD]1Legacy NDC, 2 package rows20140821_bafadc36-5019-4f18-a4fd-85f8d4a70053.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOXHYDRATING LIP BALM SPF 15 SUNSCREEN ASAP (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE) GEL [AUSTRALIAN SKIN PRODUCTS PTY LTD]1
HOMOSALATEACTIVE INGREDIENTV06SV4M95SHYDRATING LIP BALM SPF 15 SUNSCREEN ASAP (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE) GEL [AUSTRALIAN SKIN PRODUCTS PTY LTD]1
OCTISALATEACTIVE INGREDIENT4X49Y0596WHYDRATING LIP BALM SPF 15 SUNSCREEN ASAP (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE) GEL [AUSTRALIAN SKIN PRODUCTS PTY LTD]1
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WMHYDRATING LIP BALM SPF 15 SUNSCREEN ASAP (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE) GEL [AUSTRALIAN SKIN PRODUCTS PTY LTD]1
AVOBENZONEACTIVE MOIETYG63QQF2NOXHYDRATING LIP BALM SPF 15 SUNSCREEN ASAP (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE) GEL [AUSTRALIAN SKIN PRODUCTS PTY LTD]1
HOMOSALATEACTIVE MOIETYV06SV4M95SHYDRATING LIP BALM SPF 15 SUNSCREEN ASAP (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE) GEL [AUSTRALIAN SKIN PRODUCTS PTY LTD]1
OCTISALATEACTIVE MOIETY4X49Y0596WHYDRATING LIP BALM SPF 15 SUNSCREEN ASAP (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE) GEL [AUSTRALIAN SKIN PRODUCTS PTY LTD]1
OCTOCRYLENEACTIVE MOIETY5A68WGF6WMHYDRATING LIP BALM SPF 15 SUNSCREEN ASAP (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE) GEL [AUSTRALIAN SKIN PRODUCTS PTY LTD]1
.ALPHA.-BISABOLOL, (+)-INACTIVE INGREDIENT105S6I733ZHYDRATING LIP BALM SPF 15 SUNSCREEN ASAP (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE) GEL [AUSTRALIAN SKIN PRODUCTS PTY LTD]1
BERGAMOT OILINACTIVE INGREDIENT39W1PKE3JIHYDRATING LIP BALM SPF 15 SUNSCREEN ASAP (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE) GEL [AUSTRALIAN SKIN PRODUCTS PTY LTD]1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KHYDRATING LIP BALM SPF 15 SUNSCREEN ASAP (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE) GEL [AUSTRALIAN SKIN PRODUCTS PTY LTD]1
ETHYL MACADAMIATEINACTIVE INGREDIENTANA2NCS6V1HYDRATING LIP BALM SPF 15 SUNSCREEN ASAP (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE) GEL [AUSTRALIAN SKIN PRODUCTS PTY LTD]1
ETHYL METHYLPHENYLGLYCIDATEINACTIVE INGREDIENTUD51D5KR4AHYDRATING LIP BALM SPF 15 SUNSCREEN ASAP (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE) GEL [AUSTRALIAN SKIN PRODUCTS PTY LTD]1
GINGERINACTIVE INGREDIENTC5529G5JPQHYDRATING LIP BALM SPF 15 SUNSCREEN ASAP (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE) GEL [AUSTRALIAN SKIN PRODUCTS PTY LTD]1
GRAPEFRUIT OILINACTIVE INGREDIENTYR377U58W9HYDRATING LIP BALM SPF 15 SUNSCREEN ASAP (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE) GEL [AUSTRALIAN SKIN PRODUCTS PTY LTD]1
HYDROGENATED POLYBUTENE (1300 MW)INACTIVE INGREDIENT7D1YQ9Y5EZHYDRATING LIP BALM SPF 15 SUNSCREEN ASAP (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE) GEL [AUSTRALIAN SKIN PRODUCTS PTY LTD]1
LEMON OILINACTIVE INGREDIENTI9GRO824LLHYDRATING LIP BALM SPF 15 SUNSCREEN ASAP (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE) GEL [AUSTRALIAN SKIN PRODUCTS PTY LTD]1
LIMONENE, (+)-INACTIVE INGREDIENTGFD7C86Q1WHYDRATING LIP BALM SPF 15 SUNSCREEN ASAP (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE) GEL [AUSTRALIAN SKIN PRODUCTS PTY LTD]1
MALIC ACIDINACTIVE INGREDIENT817L1N4CKPHYDRATING LIP BALM SPF 15 SUNSCREEN ASAP (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE) GEL [AUSTRALIAN SKIN PRODUCTS PTY LTD]1
MANDARIN OILINACTIVE INGREDIENTNJO720F72RHYDRATING LIP BALM SPF 15 SUNSCREEN ASAP (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE) GEL [AUSTRALIAN SKIN PRODUCTS PTY LTD]1
NIACINAMIDEINACTIVE INGREDIENT25X51I8RD4HYDRATING LIP BALM SPF 15 SUNSCREEN ASAP (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE) GEL [AUSTRALIAN SKIN PRODUCTS PTY LTD]1
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P8HYDRATING LIP BALM SPF 15 SUNSCREEN ASAP (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE) GEL [AUSTRALIAN SKIN PRODUCTS PTY LTD]1
TRICAPRYLININACTIVE INGREDIENT6P92858988HYDRATING LIP BALM SPF 15 SUNSCREEN ASAP (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE) GEL [AUSTRALIAN SKIN PRODUCTS PTY LTD]1

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 82 of 191 · 3,806 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
e l f Camo Semi Matte CC SPF 30 Rich 640 WZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.cbf949b3-e640-48eb-acf6-fccd6f2588652025-10-31WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: 4X49Y0596W
e l f Camo Semi Matte CC SPF 30 Rich 650 CZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.b8bfad36-54b7-42f3-bb5b-5eda1a10f0212025-10-31WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: 4X49Y0596W
e l f Camo Semi Matte CC SPF 30 Rich 660 NZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.853100ea-a9dc-43eb-9715-125b543d2be02025-10-31WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: 4X49Y0596W
e l f Camo Semi Matte CC SPF 30 Tan 400 WZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.e4f2b579-4886-4e20-a527-c033e9d60bf52025-10-31WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: 4X49Y0596W
e l f Camo Semi Matte CC SPF 30 Tan 460 WZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.49255019-fa24-4667-b527-ef7189a51f122025-10-31WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: 4X49Y0596W
SEKKISEI HERBAL UV DEFENSE gelAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKOS America, Inc.cb0faa3a-68f8-49c5-8c28-3338b1b27cd82025-10-31WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUNSCREEN SPF45 BROAD SPECTRUMAVOBENZONE, HOMOSALATE, OCTISALATESEORIN COMPANY Co., Ltd.4260e410-d2d5-71b4-e063-6294a90a05b82025-10-30WarningsExact identifier
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
WEIGHTLESS PROTECTION SPF 30OCTINOXATE, ZINC OXIDE, OCTISALATEBotanical Science Technologiesde9a97b8-6633-4d71-e053-2995a90a5e8f2025-10-30WarningsExact identifier
unii: 4X49Y0596W
Avinichi Noni Sol Shield Cream SPF 30OCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE AND AVOBENZONEInnovation Brands Inc.9e534e32-efea-4dcf-adc1-18de3847ac042025-10-30WarningsExact identifier
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
Neutrogena Ultra Sheer Face Sunscreen SPF 60AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKenvue Brands LLC23670a30-6619-0651-e063-6394a90af9782025-10-24WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
AVOBENZONE,OCTINOXATE,OCTISALATE,OCTOCRYLENECHOP SAVER FRESH CITRUS SPF 15 LIP BALMGood for the Goose Products, LLC2786cec8-0b8e-9c83-e063-6394a90ab3382025-10-23WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
unii: 4X49Y0596W
Good Defense Daily Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATEOffspring Beauty Co.2a462e60-6353-f791-e063-6294a90a62e32025-10-23WarningsExact identifier
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
PHOTO FINISH INVISIBLE SPF 45 BROAD SPECTRUM SPF 45 PRIMERAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENESMASHBOX BEAUTY COSMETICS, INC41c4e135-c6df-82d4-e063-6294a90a0ad32025-10-22WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
Body Glaze Essence SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERBGROUP Co., Ltd2a017658-f5ff-d374-e063-6394a90aa5cc2025-10-21WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
Miffy Sunny Defense SPF StickHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONERBGROUP Co., Ltd24802b17-c0ba-1075-e063-6394a90addd52025-10-21WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
Sunny Defense SPF StickAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERBGROUP Co., Ltd18632155-5feb-5759-e063-6294a90ab88c2025-10-21WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
Paul Frank Sunny Defense SPF StickAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERBGROUP Co., Ltd26345203-3393-60ba-e063-6394a90a7e922025-10-21WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
Keith Haring Tone Blur Essence SunscreenHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONERBGROUP Co., Ltd1d578196-c785-9914-e063-6394a90a05332025-10-21WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
luminous aqua sunscreen mistAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERBGROUP Co., Ltd29fc0c2b-8d10-8704-e063-6394a90ad5042025-10-21WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
DEWYTREE URBAN SHADE HYALURONIC LIGHTWEIGHT SUNSCREENOCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONEDEWYTREE CO. ,LTD2f1ca6e0-f689-57c7-e063-6394a90a3da52025-10-21WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W

Reported adverse events (FAERS/openFDA)#

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