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 28 of 193 · 3,848 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lancome Paris UV Expert Aquagel Defense 50 Plus SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Incc500e58f-38b0-454e-8923-912844276b172026-03-20WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
Sunscreen SPF 50AVOBENZONE 3% , HOMOSALATE 10%,OCTISALATE 5%Rocky Mountain9647b817-653f-45e5-b71a-ee9ad82e84eb2026-03-18WarningsExact identifier
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
Kids Sunscreen SPF 50AVOBENZONE 3% , HOMOSALATE 10%,OCTISALATE 5%Rocky Mountain34891204-3485-44ac-aaf1-80d57593128c2026-03-18WarningsExact identifier
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
OSKIN New York Coffee BB Cream SPF 30TITANIUM DIOXIDE, OCTOCRYLENE, ZINC OXIDEO'Skin Studio NY29dae75a-4368-432a-9cf8-f0f021f09e292026-03-17WarningsExact identifier
unii: 5A68WGF6WM
BODY / FACE SUNSCREEN SUNBODY / FACE SUNSCREEN SUNGuanghzou AiXin Biotech Co., Ltd39035b99-e560-e6b6-e063-6294a90a19c62026-03-17WarningsExact identifier
unii: V06SV4M95S
SPF 50 Chemical Fragrance free SLAMAVABENZONE 3% HOMOSALATE 10% OCTOCRYLENE 6%Slam Lotionadce05cf-da63-49bc-bada-78665e2b7ce82026-03-17WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
SPF 50 Chemical Gentleman SLAMAVABENZONE 3% HOMOSALATE 10% OCTOCRYLENE 6%Slam Lotionde261b15-395e-4e9c-beea-24bea0b695a82026-03-17WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
Avobenzone, Homosalate, Octisalate, OctocryleneAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETrader Joe's Company4d3a36b9-7d63-01ac-e063-6294a90af4fb2026-03-17Warnings, Adverse reactionsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
Redneck SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERedneck Sunscreen LLC4d3a460b-1b98-2906-e063-6294a90a36692026-03-17WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
SunscreenBROAD SPECTRUM SPF 30SKNVCARE, LLC4d3ad051-3729-06fd-e063-6394a90ad0fe2026-03-17WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
unii: 4X49Y0596W
Redneck SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERedneck Sunscreen LLC4d3cc62d-9e2f-c929-e063-6294a90a913a2026-03-17WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
SOME BY MI TRUECICA AQUA CALMING SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEPERENNEBELL Co., Ltd.4d42d5aa-d12e-1086-e063-6294a90a12df2026-03-17WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
GOODAL HEARTLEAF SOOTHING QUICK SLIDING SUNSCREEN StickAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECLIO COSMETICS Co., Ltd.bce6008b-3dab-44e4-9a07-d996bf652d072026-03-17WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
MIZON SNAIL REPAIR INTENSIVE BB No. 23ZINC OXIDE, OCTISALATE, OCTOCRYLENEPFD Co.,Ltd.4d206947-1e89-7ef1-e063-6394a90a7d072026-03-16WarningsExact identifier
unii: 5A68WGF6WM
unii: 4X49Y0596W
MIZON SNAIL REPAIR INTENSIVE BB No. 25ZINC OXIDE, OCTISALATE, OCTOCRYLENEPFD Co.,Ltd.4d207687-b58f-916d-e063-6394a90a737f2026-03-16WarningsExact identifier
unii: 5A68WGF6WM
unii: 4X49Y0596W
MIZON SNAIL REPAIR INTENSIVE BB No. 31ZINC OXIDE, OCTISALATE, OCTOCRYLENEPFD Co.,Ltd.4d20a060-fedd-d2f2-e063-6294a90a5cc02026-03-16WarningsExact identifier
unii: 5A68WGF6WM
unii: 4X49Y0596W
MIZON SNAIL REPAIR INTENSIVE BB No. 27ZINC OXIDE, OCTISALATE, OCTOCRYLENEPFD Co.,Ltd.4d210edf-0966-87c8-e063-6394a90a30c72026-03-16WarningsExact identifier
unii: 5A68WGF6WM
unii: 4X49Y0596W
Advanced Formula Lip Balm SPF 25 Blood OrangeAVOBENZONE, OCTINOXATEAnthony Skin LLC74853b40-a773-4488-98a9-c8029ad211342026-03-16WarningsExact identifier
unii: G63QQF2NOX
Advanced Formula Lip Balm SPF 25AVOBENZONE, OCTINOXATEAnthony Skin LLC74d7bc30-db15-4cfc-8918-40897d54da702026-03-16WarningsExact identifier
unii: G63QQF2NOX
CVS SPF 70 Sport Face SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS26e66240-97ae-103d-e063-6394a90a9b5a2026-03-16WarningsExact 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.