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 98 of 190 · 3,800 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AHAVA Extreme Daily Firmness And Protection Broad Spectrum SPF30HOMOSALATE, OCTISALATE, AVOBENZONE, ENSULIZOLE, AND OCTOCRYLENEAHAVA Dead Sea Laboratories Ltdb22af9ef-4b69-4e70-a65d-f421e1d178af2025-08-01WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
No7 Restore and Renew Face and Neck Multi Action Day Cream Sunscreen Broad Spectrum SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENEBCM Cosmetique SAS3f0500cc-013b-7069-e063-6294a90a1a5f2025-08-01WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
unii: 4X49Y0596W
Equate SUNSCREEN spf 50 SPORT broadspectrumAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEWalmart4e5280b2-1437-4d97-bb4c-db1a1632fea72025-07-31WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
Face Reality Brilliant Defense Sunscreen SPF 50OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONEFace Reality,LLC618f58b7-2f29-4dff-8c3a-4fdbe1eb8ce42025-07-29WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
4 IN LOOK Ginseng Anit wrink Anti wrinkle essenceNIACINAMIDEGuangzhou Yanhou Cosmetics Co., Ltd.3b1c9d30-ebaa-217d-e063-6294a90a1ca72025-07-29WarningsExact identifier
unii: 25X51I8RD4
SPF30 unseen sunscreen stick 01AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.3afa3bdb-e924-55c1-e063-6394a90af3522025-07-28WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
Basin Santas Cookies SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc.3b016dcf-fb74-916f-e063-6294a90a683d2025-07-28WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
unii: 4X49Y0596W
Basin Vanilla SPF 30 Broad Spectrum Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONERetail Concepts of Minnesota, Inc.3b01c6a4-2230-c83e-e063-6294a90aa66d2025-07-28WarningsExact identifier
unii: G63QQF2NOX
unii: 4X49Y0596W
Basin Peppermint Swirl SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc.3b022c84-00a5-ece9-e063-6294a90a09bd2025-07-28WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
unii: 4X49Y0596W
Basin Winter Berry Blast SPF15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc.3b02c3f2-a43a-0d29-e063-6394a90a76b52025-07-28WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
unii: 4X49Y0596W
KARA VITA Moisturizing Sunscreen with DNArescueOXYBENZONE, AVOBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATEKara Vita, Inc.2130e9ac-5946-4b00-94d0-a78fd1ccfd132025-07-25WarningsExact identifier
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
Dolce and Gabbana Everlast Foundation SPF 20 01N LightOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L2ccf4e45-4cec-417d-9f4c-28f376025f1d2025-07-25WarningsExact identifier
unii: 5A68WGF6WM
unii: 4X49Y0596W
celazome Moisturizing SPF 30 ActiveOXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATEDermazone LLC5ec1510d-1465-4849-9e23-f16e11ff0e652025-07-25WarningsExact identifier
unii: V06SV4M95S
unii: 4X49Y0596W
celazome Moisturizing SPF 29 Active with DNArescueOXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATEDermazone LLC99fb90ca-6527-459b-8af2-627ea9abe11b2025-07-25WarningsExact identifier
unii: V06SV4M95S
unii: 4X49Y0596W
Leg and Body Makeup Broad Spectrum SPF 25OCTISALATE 3.2% OCTOCRYLENE 6%Baxter of California, LLC14adc826-6e9d-382a-e063-6294a90a5d792025-07-24WarningsExact identifier
unii: 5A68WGF6WM
unii: 4X49Y0596W
Tiege Hanley AM Morning Facial Moisturizer with SPF 20AVOBENZENE, OCTINOXATE, OCTOCRYLENETIEGE HANLEY, Inc22086cd8-2126-120e-e063-6394a90a561e2025-07-24WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
Pelotan Sunscreen Broad Spectrum SPF 30AVOBENZONE, OCTINOXATE, OCTOCRYLENEPelotan LLC3a9f94eb-98b7-5a20-e063-6394a90a173b2025-07-23WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
Basin Frosted Orange Cream SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc.3a9fc050-f74f-a431-e063-6294a90ad4c22025-07-23WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
unii: 4X49Y0596W
Pelotan Sunscreen Broad Spectrum SPF 30AVOBENZONE, OCTINOXATE, OCTOCRYLENEPelotan LLC3aa0799b-0790-2476-e063-6294a90a8bcc2025-07-23WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
Basin Italian Gelato SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc.3a89106d-dbf0-e6ea-e063-6294a90a60f32025-07-22WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
unii: 4X49Y0596W

Reported adverse events (FAERS/openFDA)#

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