Home NDC 13630-0022-4 Australian Gold
Product NDC 13630-0022
Requested package NDC 13630-0022-4
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 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 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 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [PRIME PACKAGING, INC.] 1 OCTISALATE ACTIVE INGREDIENT 4X49Y0596W AUSTRALIAN GOLD BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [PRIME PACKAGING, INC.] 1 OCTOCRYLENE ACTIVE INGREDIENT 5A68WGF6WM AUSTRALIAN GOLD BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [PRIME PACKAGING, INC.] 1 AVOBENZONE ACTIVE MOIETY G63QQF2NOX AUSTRALIAN GOLD BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [PRIME PACKAGING, INC.] 1 OCTISALATE ACTIVE MOIETY 4X49Y0596W AUSTRALIAN GOLD BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [PRIME PACKAGING, INC.] 1 OCTOCRYLENE ACTIVE MOIETY 5A68WGF6WM AUSTRALIAN GOLD BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [PRIME PACKAGING, INC.] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M AUSTRALIAN GOLD BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [PRIME PACKAGING, INC.] 1 DIETHYLHEXYL 2,6-NAPHTHALATE INACTIVE INGREDIENT I0DQJ7YGXM AUSTRALIAN GOLD BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [PRIME PACKAGING, INC.] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD AUSTRALIAN GOLD BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [PRIME PACKAGING, INC.] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA AUSTRALIAN GOLD BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [PRIME PACKAGING, INC.] 1 FD&C YELLOW NO. 5 INACTIVE INGREDIENT I753WB2F1M AUSTRALIAN GOLD BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [PRIME PACKAGING, INC.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX AUSTRALIAN GOLD BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [PRIME PACKAGING, INC.] 1 POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) INACTIVE INGREDIENT T9296U138P AUSTRALIAN GOLD BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [PRIME PACKAGING, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R AUSTRALIAN 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 13 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join VERSED MULTI SERUM SKIN TINT SPF 40 TAN NEUTRAL ZINC OXIDE COSMAX USA, CORP 56477f58-3878-81fa-e063-6294a90a87b7 2026-07-10 Warnings Exact identifier application number: M020 VERSED MULTI SERUM SKIN TINT SPF 40 DEEP WRM ZINC OXIDE COSMAX USA, CORP 5647ae2c-bcba-63c0-e063-6394a90ad5bc 2026-07-10 Warnings Exact identifier application number: M020 VERSED MULTI SERUM SKIN TINT SPF 40 TAN DEEP WRM ZINC OXIDE COSMAX USA, CORP 56478f3d-f25c-bef7-e063-6294a90ade09 2026-07-10 Warnings Exact identifier application number: M020 VERSED MULTI SERUM SKIN TINT SPF 40 TAN DEEP COOL ZINC OXIDE COSMAX USA, CORP 564796f8-072f-61f2-e063-6394a90ab394 2026-07-10 Warnings Exact identifier application number: M020 VERSED MULTI SERUM SKIN TINT SPF 40 DEEP COOL ZINC OXIDE COSMAX USA, CORP 5647e63c-a695-1b40-e063-6394a90a5767 2026-07-10 Warnings Exact identifier application number: M020 VERSED MULTI SERUM SKIN TINT SPF 40 DEEP NEUTRAL ZINC OXIDE COSMAX USA, CORP 5647d0f1-945f-b0b7-e063-6294a90aafe2 2026-07-10 Warnings Exact identifier application number: M020 LAURA GELLER X BLISS SHINE - N - SHIELD LIP BALM SPF 15 Sunset Sands ZINC OXIDE COSMAX USA, CORP 5648da76-5a67-605a-e063-6294a90a4e3b 2026-07-10 Warnings Exact identifier application number: M020 Coco and Eve Tan Boosting Anti Aging Body Oil SPF 45 HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE COSMAX USA, CORP 5648d637-9743-97a7-e063-6294a90ad8a1 2026-07-10 Warnings Exact identifier application number: M020 The Mineral Lip One SPF 45 Nourishing Lip Tint Vanilla Cloud ZINC OXIDE COSMAX USA, CORP 5648c90b-b814-c16e-e063-6394a90a3e1f 2026-07-10 Warnings Exact identifier application number: M020 The Mineral Lip One SPF 45 Nourishing Lip Tint Berry Balmy ZINC OXIDE COSMAX USA, CORP 56490982-200d-e3a7-e063-6394a90a72a4 2026-07-10 Warnings Exact identifier application number: M020 PRIME Prometics LipOil SPF 35 Warm Sienna ZINC OXIDE COSMAX USA, CORP 56491794-712d-1306-e063-6394a90a4707 2026-07-10 Warnings Exact identifier application number: M020 PRIME Prometics LipOil SPF 35 Bright Berry ZINC OXIDE COSMAX USA, CORP 56491833-5053-c85e-e063-6294a90ac4f5 2026-07-10 Warnings Exact identifier application number: M020 PRIME Prometics LipOil SPF 35 Nude Rose ZINC OXIDE COSMAX USA, CORP 56493964-1d5b-2fc7-e063-6394a90a7492 2026-07-10 Warnings Exact identifier application number: M020 PRIME Prometics LipOil SPF 35 Soft Petal ZINC OXIDE COSMAX USA, CORP 5649df7b-9d2c-d8eb-e063-6394a90acf99 2026-07-10 Warnings Exact identifier application number: M020 PRIME Prometics LipOil SPF 35 Nude Glow ZINC OXIDE COSMAX USA, CORP 564a6566-442c-b933-e063-6294a90a6f9b 2026-07-10 Warnings Exact identifier application number: M020 SOFIE PAVITT FACE SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE COSMAX USA., CORP 564ae5d2-1504-9623-e063-6394a90a2fa5 2026-07-10 Warnings Exact identifier application number: M020 IDEALOVE HYDROGLOW DAILY SUNSCREEN SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE COSMAX USA, CORP 564b284c-3248-c6c0-e063-6394a90a1103 2026-07-10 Warnings Exact identifier application number: M020 SOFIE PAVITT FACE SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE COSMAX USA., CORP 564b1ed2-aa98-a334-e063-6294a90a169b 2026-07-10 Warnings Exact identifier application number: M020 LAURA GELLER X BLISS SHINE - N - SHIELD LIP BALM SPF 15 GOLDEN HOUR ZINC OXIDE COSMAX USA, CORP 564b559e-6fe8-e98e-e063-6294a90a8f0e 2026-07-10 Warnings Exact identifier application number: M020 LAURA GELLER X BLISS SHINE - N - SHIELD LIP BALM SPF 15 BLISS ON THE BEACH ZINC OXIDE COSMAX USA, CORP 564b63f2-701e-f5bd-e063-6394a90af797 2026-07-10 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 13630-0022-4 13630002204 177 mL in 1 CAN (13630-0022-4) 177 ml 2013-10-31 2023-02-28 No No Current