Australian Gold

Product NDC
13630-0022
11-digit product format
136300022
Labeler code
13630
Product ID
13630-0022_e1e84d40-7a99-7e13-e053-2995a90aa07e
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Octisalate, Octocrylene
Dosage form
SPRAY
Route
TOPICAL
Labeler
Prime Packaging, Inc.
Application
M020
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-10-31
Marketing end
2023-02-28
Substance
AVOBENZONE; OCTISALATE; OCTOCRYLENE
Active strength
16 mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct13630-0022DDiscontinued by firm2026-10-15
excluded packagepackage13630-002213630-0022-4DDiscontinued by firm2026-10-15

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage13630-0022-4d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage13630-0022-4f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage13630-0022-42ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage13630-0022-4a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage13630-0022-4cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage13630-0022-4cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage13630-0022-4302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage13630-0022-4ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage13630-0022-40efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage13630-0022-4ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage13630-0022-4367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage13630-0022-4557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOXAUSTRALIAN GOLD BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [PRIME PACKAGING, INC.]1
OCTISALATEACTIVE INGREDIENT4X49Y0596WAUSTRALIAN GOLD BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [PRIME PACKAGING, INC.]1
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WMAUSTRALIAN GOLD BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [PRIME PACKAGING, INC.]1
AVOBENZONEACTIVE MOIETYG63QQF2NOXAUSTRALIAN GOLD BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [PRIME PACKAGING, INC.]1
OCTISALATEACTIVE MOIETY4X49Y0596WAUSTRALIAN GOLD BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [PRIME PACKAGING, INC.]1
OCTOCRYLENEACTIVE MOIETY5A68WGF6WMAUSTRALIAN GOLD BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [PRIME PACKAGING, INC.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MAUSTRALIAN GOLD BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [PRIME PACKAGING, INC.]1
DIETHYLHEXYL 2,6-NAPHTHALATEINACTIVE INGREDIENTI0DQJ7YGXMAUSTRALIAN GOLD BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [PRIME PACKAGING, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDAUSTRALIAN GOLD BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [PRIME PACKAGING, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAUSTRALIAN GOLD BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [PRIME PACKAGING, INC.]1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MAUSTRALIAN GOLD BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [PRIME PACKAGING, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXAUSTRALIAN GOLD BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [PRIME PACKAGING, INC.]1
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)INACTIVE INGREDIENTT9296U138PAUSTRALIAN GOLD BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [PRIME PACKAGING, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RAUSTRALIAN GOLD BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [PRIME PACKAGING, INC.]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 19 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Not there spf broad spectrum spf40 moisturizerAVOBENZONE 3% ,HOMOSALATE 10% ,OCTISALATE 5% ,OCTOCRYLENE 8% ,ZINC OXIDE 4%Foshan Sugar Max Cosmetics CO.,Ltd546f0474-4102-26d0-e063-6394a90a388b2026-06-17WarningsExact identifier
application number: M020
Ultra Violette Velvet Screen Blurring Mineral Skinscreen Broad Spectrum SPF 40ZINC OXIDEGrace and Fire USA Inc.52d4b1c1-7431-4f8c-e063-6294a90ad4822026-06-17WarningsExact identifier
application number: M020
EVIL GOODS TALLOW SUNSCREEN SPF30ZINC OXIDEMoes Group LLC54751f23-5723-0407-e063-6294a90a4a962026-06-17WarningsExact identifier
application number: M020
Amber Sunglaze Sheer Body Mist Sunscreen SPF30AVOBENZONE, OCTISALATE, OCTOCRYLENEKoco Life LLC5478fb36-e972-f824-e063-6294a90a567f2026-06-17WarningsExact identifier
application number: M020
Elaine Sterling Hydrating SunscreenZINC OXIDEElaine Sterling Enterprises5479e862-aca5-7541-e063-6394a90ad0c52026-06-17WarningsExact identifier
application number: M020
No7 Restore and Renew Multi Action Day Cream Sunscreen Broad Spectrum SPF 25AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENEBCM Cosmetique SAS545aa56a-ed07-acd6-e063-6394a90ae0c72026-06-16WarningsExact identifier
application number: M020
MAYBELLINE NEW YORK FIT ME DEWY PLUS SMOOTH FOUNDATION SPF 18 SUNSCREENOCTISALATELOreal USA Products Inc3b99ab06-ba4c-4ddd-a057-60028eedd67d2026-06-16WarningsExact identifier
application number: M020
TERRA LOTUS SPF 50 ORGANIC TALLOW SUNSCREENZINCOXIDEMoes Group LLC54617bf2-1d8d-531e-e063-6294a90a70802026-06-16WarningsExact identifier
application number: M020
Daily Defence Mineral Sunscreen SPF 50 Fragrance FreeZINC OXIDEUltraceuticals Pty Ltd5461ee82-0297-ce22-e063-6294a90a729b2026-06-16WarningsExact identifier
application number: M020
GlowBiotics Tinted Sunscreen SPF 30ZINC OXIDERum Brands, LLC544dba29-4785-4ab6-e063-6394a90a17b32026-06-16WarningsExact identifier
application number: M020
Societe Prime and DefendZINC OXIDE SUNSCREENSociete Clinical Skincare5439bd31-5ee1-9bca-e063-6394a90a748c2026-06-16WarningsExact identifier
application number: M020
Societe CoverShield Tinted SPFZINC OXIDESociete Clinical Skincare545efbc4-82d4-f126-e063-6294a90a97102026-06-16WarningsExact identifier
application number: M020
TITAN TALLOW SPF 50 ORGANIC TALLOW SUNSCREENZINC OXIDEMoes Group LLC546b0702-a3cc-fd6f-e063-6394a90af8492026-06-16WarningsExact identifier
application number: M020
365 WHOLE FOODS MARKET MINERAL SPF 30ZINC OXIDEWhole Foods Market, Inc.5ce712d6-cafd-4a80-9f8c-2149fdebff542026-06-16WarningsExact identifier
application number: M020
365 WHOLE FOODS MARKET MINERAL SPF 50ZINC OXIDEWhole Foods Market, Inc.1f8387be-d871-435b-baef-e537c67a510a2026-06-15WarningsExact identifier
application number: M020
365 WHOLE FOODS MARKET SUNSCREEN CLEAR COCONUT VANILLA SPF 50OCTOCRYLENE, OCTISALATE, AVOBENZONE, AND HOMOSALATEWhole Foods Market, Inc.82771f22-0197-40ba-97d2-2386152790ed2026-06-15WarningsExact identifier
application number: M020
365 WHOLE FOODS MARKET SUNSCREEN CLEAR COCONUT VANILLA SPF 30OCTOCRYLENE, OCTISALATE, AND AVOBENZONEWhole Foods Market, Inc.1c31f466-6a0d-46ce-9346-d2a0eb46c8d02026-06-15WarningsExact identifier
application number: M020
Shield by HEALTHY SKIN LAB MD SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEHEALTHY SKIN LAB LIMITED6838b754-9915-48ff-af35-5338dbd06ac42026-06-15WarningsExact identifier
application number: M020
Solvyn Mineral Sunscreen SPF 50ZINC OXIDESolvyn Skin LLCb0a8d028-87d2-4339-8879-c62cbf8415f22026-06-15WarningsExact identifier
application number: M020
Amrit Ocean Resort Mineral Sunscreen SPF 50ZINC OXIDESolvyn Skin, LLC112364cd-a445-46c2-b2f3-f9705d682cf62026-06-15WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13630-0022-413630002204177 mL in 1 CAN (13630-0022-4) 177 ml2013-10-310000-00-00NoNoCurrent