FDA.reportPublic FDA data

Australian Gold SPF 15 Lip Balm

Product NDC
84061-128
11-digit product format
840610128
Labeler code
84061
Product ID
84061-128_49020aaa-0208-4943-e063-6394a90abaef
Type
HUMAN OTC DRUG
Nonproprietary name
Octinoxate, Octocrylene, Oxybenzone, Octisalate, Petroleum Jelly
Dosage form
STICK
Route
TOPICAL
Labeler
Australian Gold
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-01-01
Substance
OCTINOXATE; OXYBENZONE; PETROLATUM; OCTOCRYLENE; OCTISALATE
Active strength
7.5; 5; 30; 7; 5 mg/g; mg/g; mg/g; mg/g; mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
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
Australian Gold SPF 15 Lip Balm
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTINOXATE7.5 mg/g
OXYBENZONE5 mg/g
PETROLATUM30 mg/g
OCTOCRYLENE7 mg/g
OCTISALATE5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4Y5P7MUD51Internal UNII lookup
95OOS7VE0YInternal UNII lookup
4T6H12BN9UInternal UNII lookup
5A68WGF6WMInternal UNII lookup
4X49Y0596WInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
92966c2d-b61a-4f8b-a5c1-8dfb6352c82fAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84061-128-01Australian Gold SPF 15 Lip Balm1 g in 1 CONTAINERSTICK11

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 2 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Intense Therapy Lip Balm Asian PearSUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLCacace707-6671-4818-86f2-d9813792157a2026-09-08WarningsExact identifier
application number: M020
Intense Therapy Lip Balm Basil LemonSUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLC277cb44d-608a-4ffc-a2a5-ac57d33d214c2026-09-08WarningsExact identifier
application number: M020
Intense Therapy Lip Balm Black CherrySUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLC8f413bd6-258c-4c3c-89d1-369938c857202026-09-08WarningsExact identifier
application number: M020
Intense Therapy Lip Balm Cucumber LimeSUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLC5f15bee9-9bf4-4f27-a6b5-4205deb625f62026-09-08WarningsExact identifier
application number: M020
Intense Therapy Lip Balm Winter MelonSUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLCe7792b4e-a6d2-487e-ba28-27b68e6d7e272026-09-08WarningsExact identifier
application number: M020
Jack Black Intense Therapy Lip Balm Vanilla BourbonAVOBENZONE, OCTINOXATE LIP BALM SUNSCREENJack Black, LLC517040d1-e6ed-40ca-a46f-2f75403dbc3c2026-09-08WarningsExact identifier
application number: M020
Intense Therapy Lip Balm Mango and MandarinSUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLC8c55d1cd-cdd6-468b-8a17-b940c62101162026-09-08WarningsExact identifier
application number: M020
Jack Black Intensive Therapy Lip Balm Mango Chili LimeAVOBENZONE, OCTINOXATE LIP BALM SUNSCREENJack Black, LLC51349d57-b14d-4798-8d68-03fbe3713d1e2026-09-08WarningsExact identifier
application number: M020
Jack Black Sun Guard Sunscreen SPF45SUNSCREENJack Black, LLC3cc86bb2-05ce-47eb-8c71-f4f116ca58402026-09-08WarningsExact identifier
application number: M020
Jack Black Intense Thearpy Lip Balm SPF25, Lemon and Shea ButterLIP BALM SUNSCREENJack Black, LLC518cb17a-fdaa-4a60-93fc-708305366eb82026-09-08WarningsExact identifier
application number: M020
Jack Black Lavender Lip Balm 0.25ozLIP BALM SUNSCREENJack Black, L.L.C.e8c6a6d9-1093-41f1-87d5-faf8583d43192026-09-08WarningsExact identifier
application number: M020
SPF15 lip balm 01OCTOCRYLENE, OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.f8695305-b89d-c21c-e053-6394a90a0e842026-09-08WarningsExact identifier
application number: M020
Sunscreen stickAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECosmuses Cosmetics (Ningbo) Co., Ltd.e9f963ee-a98c-efc1-e053-2a95a90aaf532026-09-08WarningsExact identifier
application number: M020
SPF30 Sunscreen 01AVOBENZONE ,HOMOSALATE,OCTOCRYLENE, OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.5b04751d-32e9-a7e2-e063-6294a90aefbd2026-09-08WarningsExact identifier
application number: M020
Juyasuyon Invisible SunscreenHOMOSALATE,OCTOCRYLENE,OCTISALATE,BEMOTRIZINOL,AVOBENZONEGuangdong Aimu Biological Technology Co., Ltd5ab335b5-bb9e-4642-e063-6294a90a39862026-09-05WarningsExact identifier
application number: M020
No7 Future Renew Defense Shield SPF 50AVOBENZONE, OCTINOXATE, OCTISALATEBCMC41cc2c52-c6a4-611c-e063-6294a90aae012026-09-03WarningsExact identifier
application number: M020
WALMART EQUATE SUNSCREEN SPF 50 SPORT BROAD SPECTRUMAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALMART, INC.58b5d0ce-9157-9dee-e063-6394a90ab5432026-09-02WarningsExact identifier
application number: M020
Chantecaille Ultra Sun Protection Sunscreen SPF 45AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEChantecaille Beaute Inc6186ea56-7d56-43f5-985d-a012f1296afa2026-09-02WarningsExact identifier
application number: M020
ULTRA VIOLETTE Fave Screen Broad Spectrum SPF 50AVOBENZONE, BEMOTRIZINOL, OCTISALATEGrace and Fire USA5739c5b9-00d8-75a8-e063-6394a90aa8c72026-09-01WarningsExact identifier
application number: M020
Sun Wave Anti Aging Insta Dry SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Life Brands, LLC2d5fa597-08a8-41ca-ba9e-b52e41a5c70c2026-09-01WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84061-128-01840610128011 g in 1 CONTAINER (84061-128-01) 1 g2025-01-01NoNoCurrent