Home NDC 13630-0065 Australian Gold
Product NDC 13630-0065
11-digit product format 136300065
Labeler code 13630
Product ID 13630-0065_e1e83ae8-5ceb-3f27-e053-2a95a90a7a7e
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone, Octocrylene, and Oxybenzone
Dosage form SPRAY
Route TOPICAL
Labeler Prime Packaging, Inc.
Application M020
Marketing category OTC MONOGRAPH FINAL
Marketing start 2012-04-25
Marketing end 2022-06-30
Substance AVOBENZONE; OCTOCRYLENE; OXYBENZONE
Active strength 8 mg/mL; mg/mL; mg/mL
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record 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 date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 13630-0065-4 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 13630-0065-4 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 13630-0065-4 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 13630-0065-4 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 13630-0065-4 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 13630-0065-4 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 13630-0065-4 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 13630-0065-4 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 13630-0065-4 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 13630-0065-4 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 13630-0065-4 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 13630-0065-4 557ba5c1ecfa…9c80585c8c6e…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded AVOBENZONE ACTIVE INGREDIENT G63QQF2NOX AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.] 1 OCTOCRYLENE ACTIVE INGREDIENT 5A68WGF6WM AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.] 1 OXYBENZONE ACTIVE INGREDIENT 95OOS7VE0Y AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.] 1 AVOBENZONE ACTIVE MOIETY G63QQF2NOX AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.] 1 OCTOCRYLENE ACTIVE MOIETY 5A68WGF6WM AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.] 1 OXYBENZONE ACTIVE MOIETY 95OOS7VE0Y AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.] 1 ALKYL (C12-15) BENZOATE INACTIVE INGREDIENT A9EJ3J61HQ AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.] 1 DIBUTYL MALEATE INACTIVE INGREDIENT 4X371TMK9K AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.] 1 DIETHYLHEXYL 2,6-NAPHTHALATE INACTIVE INGREDIENT I0DQJ7YGXM AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.] 1 FD&C YELLOW NO. 5 INACTIVE INGREDIENT I753WB2F1M AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.] 1 POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) INACTIVE INGREDIENT T9296U138P AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE) 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 237 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Earths Daughter Vanilla Bean SPF 15 Broad Spectrum Sunscreen Lip Balm AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE Earth's Daughter 2ad0db95-a283-3c91-e063-6294a90ae523 2025-01-03 Warnings Exact identifier application number: M020 Earths Daughter Strawberry Breeze SPF 15 Broad Spectrum Sunscreen Lip Balm AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE Earth's Daughter 2ad129b7-4ecd-a967-e063-6294a90ad8c4 2025-01-03 Warnings Exact identifier application number: M020 Earths Daughter Citrus Blast SPF 15 Broad Spectrum Sunscreen Lip Balm AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE Earth's Daughter 2ad18f4b-4251-be82-e063-6394a90acac5 2025-01-03 Warnings Exact identifier application number: M020 Earths Daughter Creamy Coconut SPF 15 Broad Spectrum Sunscreen Lip Balm AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE Earth's Daughter 2ad1bb50-869e-8122-e063-6294a90ac724 2025-01-03 Warnings Exact identifier application number: M020 Glow Baby Brightening Setting Mist SPF 45 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Pacifica Beauty, LLC f2f53cf9-3717-07ff-e053-2a95a90a03fb 2025-01-03 Warnings Exact identifier application number: M020 Future Youth Daily Turnaround Hydrating Moisturizer SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE Pacifica Beauty, LLC 0324275f-13bc-e7b8-e063-6294a90a6902 2025-01-03 Warnings Exact identifier application number: M020 Glow Baby Super Lit SPF 30 ZINC OXIDE Pacifica Beauty, LLC f3d3eee2-a5d9-113b-e053-2995a90a7057 2025-01-03 Warnings Exact identifier application number: M020 Kind Tint SPF 30 ZINC OXIDE Pacifica Beauty, LLC f421cbf7-cfae-5eae-e053-2995a90ab35c 2025-01-03 Warnings Exact identifier application number: M020 Vegan Collagen Every Day SPF 30 AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTYL SALICYLATE Pacifica Beauty, LLC f449da32-5ade-2c78-e053-2a95a90a27a1 2025-01-03 Warnings Exact identifier application number: M020 Members Mark SPF 50 Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Sam's West Inc 2b354ab6-f241-676f-e063-6394a90a5893 2025-01-03 Warnings Exact identifier application number: M020 Vanilla Mint Lip Balm LIP BALM Casad Company Inc. 3214bff3-e133-43ca-946d-f4c5dd074760 2025-01-03 Warnings Exact identifier application number: M020 Vanilla Lip Balm LIP BALM Casad Company Inc. d27398d3-98b0-4f70-997e-6ed02559594f 2025-01-03 Warnings Exact identifier application number: M020 Cherry Lip Balm LIP BALM Casad Company Inc. b262645e-f069-420d-90ac-9eb4b82236d8 2025-01-03 Warnings Exact identifier application number: M020 Peppermint Lip Balm LIP BALM Casad Company Inc. 46a4b6d1-37e4-471d-a41b-57afe8bd9f2f 2025-01-03 Warnings Exact identifier application number: M020 Beeswax Lip Balm LIP BALM Casad Company Inc. 5301398d-82f8-495e-b3ec-0938eca16369 2025-01-03 Warnings Exact identifier application number: M020 Spearmint Lip Balm LIP BALM Casad Company Inc. ba9b5420-60b0-4528-9898-a0a5287a2aee 2025-01-03 Warnings Exact identifier application number: M020 Pomegranate Lip Balm LIP BALM Casad Company Inc. 4e943a8a-f627-4e28-bdd7-c2b63be5dca3 2025-01-03 Warnings Exact identifier application number: M020 Tropical Lip Balm LIP BALM Casad Company Inc. 5e730d21-b810-4b84-9c85-0343ab0c8d5a 2025-01-03 Warnings Exact identifier application number: M020 Green Defense Broad Spectrum SPF 30 TITANIUM DIOXIDE, ZINC OXIDE Farmacy Beauty LLC adf0f50f-6357-bc1f-e053-2a95a90ad997 2025-01-02 Warnings Exact identifier application number: M020 Sheglam Dew and Done Skin Tint with SPF 20 Bamboo ZINC OXIDE EVER FAME PTE. LTD. 2abbc7fb-ea5d-9c68-e063-6394a90a88d2 2025-01-02 Warnings Exact identifier application number: M020
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 13630-0065-4 13630006504 177 mL in 1 CAN (13630-0065-4) 177 ml 2012-04-25 0000-00-00 No No Current