Blue Lizard Sensitive Sunscreen
- Product NDC
- 0316-2045
- 11-digit product format
- 003162045
- Labeler code
- 0316
- Product ID
- 0316-2045_48345730-de18-7fb2-e063-6394a90a9b5d
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Titanium Dioxide and Zinc Oxide
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- Crown Laboratories
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2003-12-08
- Substance
- TITANIUM DIOXIDE; ZINC OXIDE
- Active strength
- 54; 108 mg/mL; mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 0316-2045 | 0316-2045-30 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 0316-2045 | 0316-2045-45 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 0316-2045 | 0316-2045-50 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 0316-2045 | 0316-2045-60 | D | Discontinued by firm | 2026-10-15 |
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.
| Captured / source date | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | 0316-2045-45 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 0316-2045-60 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 0316-2045-50 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 0316-2045-30 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 0316-2045-45 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 0316-2045-60 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 0316-2045-50 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 0316-2045-30 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 0316-2045-30 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 0316-2045-45 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 0316-2045-60 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 0316-2045-30 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 0316-2045-45 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 0316-2045-60 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 0316-2045-30 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 0316-2045-45 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 0316-2045-60 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 0316-2045-30 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 0316-2045-45 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 0316-2045-60 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 0316-2045-30 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 0316-2045-45 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 0316-2045-60 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 0316-2045-30 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 0316-2045-45 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 0316-2045-60 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0316-2045-30 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0316-2045-45 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0316-2045-60 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 0316-2045-60 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 0316-2045-45 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 0316-2045-60 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 0316-2045-45 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 0316-2045-60 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 0316-2045-45 | 557ba5c1ecfa… | 9c80585c8c6e… |
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
- Blue Lizard Sensitive Sunscreen
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| TITANIUM DIOXIDE | 54 mg/mL |
| ZINC OXIDE | 108 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 15FIX9V2JP | Internal UNII lookup |
| SOI2LOH54Z | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1e4d49f4-9e77-48b5-bce5-ff04ed885a0f | Available on FDA.report |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Related label |
|---|---|---|
| 0316-2045-10 | 2023-02-13 | Blue Lizard Sensitive |
| 0316-2045-30 | 2023-02-13 | Blue Lizard Sensitive |
| 0316-2045-40 | 2023-02-13 | Blue Lizard Sensitive |
| 0316-2045-45 | 2023-02-13 | Blue Lizard Sensitive |
| 0316-2045-50 | 2023-02-13 | Blue Lizard Sensitive |
| 0316-2045-60 | 2023-02-13 | Blue Lizard Sensitive |
| 0316-2045-10 | 2023-01-30 | Blue Lizard Sensitive |
| 0316-2045-30 | 2023-01-30 | Blue Lizard Sensitive |
| 0316-2045-40 | 2023-01-30 | Blue Lizard Sensitive |
| 0316-2045-45 | 2023-01-30 | Blue Lizard Sensitive |
| 0316-2045-50 | 2023-01-30 | Blue Lizard Sensitive |
| 0316-2045-60 | 2023-01-30 | Blue Lizard Sensitive |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0316-2045-10 | Blue Lizard Sensitive Sunscreen | 5 mL in 1 PACKET | LOTION | 5 | 19 | |
| 0316-2045-30 | Blue Lizard Sensitive Sunscreen | 89 mL in 1 TUBE | LOTION | 89 | 19 | |
| 0316-2045-40 | Blue Lizard Sensitive Sunscreen | 148 mL in 1 BOTTLE, PLASTIC | LOTION | 148 | 19 | |
| 0316-2045-45 | Blue Lizard Sensitive Sunscreen | 148 mL in 1 TUBE | LOTION | 148 | 19 | |
| 0316-2045-50 | Blue Lizard Sensitive Sunscreen | 259 mL in 1 BOTTLE, PLASTIC | LOTION | 259 | 19 | |
| 0316-2045-60 | Blue Lizard Sensitive Sunscreen | 3785 mL in 1 JUG | LOTION | 3785 | 19 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| MEDICUBE PDRN SILKY SUNSCREEN | HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE | APR US INC | 57154bec-6714-0314-e063-6294a90a4bd0 | 2026-07-20 | Warnings | M020 |
| TOCOBO Double UV Defense Set | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | PICTON Co., Ltd. | 56aff65a-aa08-dc3f-e063-6294a90acac3 | 2026-07-19 | Warnings | M020 |
| THE SPORTO Invisible Sport for Body | AVOBENZONE, OCTISALATE, AND OCTOCRYLENE | Dune Suncare, Inc. | 46564a09-909d-bcc7-e063-6294a90a627b | 2026-07-17 | Warnings | M020 |
| RR Sun Creme | HOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE | Undefined Inc | dc60b685-a7fc-47bb-ade9-44a8e3b54812 | 2026-07-17 | Warnings | M020 |
| Cetaphil Tinted Daily Facial Moisturizer SPF 50 | HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE | Galderma Laboratories, L.P. | 0ef2ebae-7198-47f4-8891-d1ca3cf54d4b | 2026-07-16 | Warnings | M020 |
| Mederma Scar Cream | AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE | PMI Branded Pharmaceuticals, Inc. | f9be5adb-dce3-4b17-939f-d80d486f2cb0 | 2026-07-16 | Warnings | M020 |
| BaseLife Pure Mineral Shield Sunscreen | ZINC OXIDE | Wintech America, Inc. | 7f741a91-6ed8-4d08-9196-d15527d044d5 | 2026-07-15 | Warnings | M020 |
| BaseLife Clear UV Defense Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Wintech America, Inc. | 128db446-93ba-4347-bd39-66177572c659 | 2026-07-15 | Warnings | M020 |
| Biore Aqua Rich Facial Mist SPF 50 | OCTOCRYLENE, OCTISALATE, AVOBENZENE, HOMOSALATE | Kao USA Inc. | 56a80a0d-b0b5-1098-e063-6294a90a5270 | 2026-07-15 | Warnings | M020 |
| Anti Aging Lip Balm Pot SPF 15 | LIP BALM | Epicuren Disocovery | 4097e28a-ed11-e16a-e063-6294a90a5e9b | 2026-07-14 | Warnings | M020 |
| HolyCow Mineral Tallow Sunscreen Face and Body SPF 50 | ZINC OXIDE | CALM ENTERPRISE LLC | 722462d8-d2ab-44ce-9065-673ab2076269 | 2026-07-14 | Warnings | M020 |
| X-Treme Cream Propolis Sunscreen SPF 45 | X-TREME CREAM | Epicuren Discovery | 3b29976e-eee0-b978-e063-6294a90accd6 | 2026-07-14 | Warnings | M020 |
| Anti-Aging Lip Balm SPF 15 | LIP BALM | Epicuren Discovery | 3cbd0550-b6e5-3e86-e063-6394a90ac07f | 2026-07-14 | Warnings | M020 |
| Zinc Oxide Perfecting Sunscreen | ZINC OXIDE | Epicuren Discovery | 1a0228f9-bf3f-a1fe-e063-6294a90a3fb5 | 2026-07-14 | Warnings | M020 |
| Vacation Face | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | Vacation INC. | 14b8a3cf-031c-4c52-ba81-e683e69d0f37 | 2026-07-14 | Warnings | M020 |
| Mederma Scar Cream | AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE | L. Perrigo Company | bd5c9df7-8dfb-4d20-9966-e148c5667b22 | 2026-07-14 | Warnings | M020 |
| Sun Juice Body Mist Sunscreen SPF30 - Watermelon Sugar PARADISO | AVOBENZONE, HOMOSALATE, OCTISALATE | Koco Life LLC | 4081a4ad-b738-5fb6-e063-6394a90a9171 | 2026-07-13 | Warnings | M020 |
| Sun Juice Body Mist Sunscreen SPF30 - Coconut Cream PARADISO | AVOBENZONE, HOMOSALATE, OCTISALATE | Koco Life LLC | 3cc5c1d8-91f8-8ad2-e063-6294a90a9229 | 2026-07-13 | Warnings | M020 |
| Olay Super Serum Body Broad Spectrum SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | The Procter & Gamble Manufacturing Company | 5513c5e2-3baf-2f09-e063-6394a90a495a | 2026-07-13 | Warnings | M020 |
| Sun Juice Body Mist Sunscreen SPF30 - Peach Sky PARADISO | AVOBENZONE, HOMOSALATE, OCTISALATE | Koco Life LLC | 3cc48592-f70d-664e-e063-6294a90ac6e8 | 2026-07-13 | Warnings | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0316-2045-10 | 00316204510 | 5 mL in 1 PACKET (0316-2045-10) | 5 ml | 2004-04-01 | 0000-00-00 | No | No | Current |
| 0316-2045-30 | 00316204530 | 89 mL in 1 TUBE (0316-2045-30) | 89 ml | 2006-01-03 | 0000-00-00 | No | No | Current |
| 0316-2045-40 | 00316204540 | 148 mL in 1 BOTTLE, PLASTIC (0316-2045-40) | 148 ml | 2003-12-08 | 0000-00-00 | No | No | Current |
| 0316-2045-45 | 00316204545 | 148 mL in 1 TUBE (0316-2045-45) | 148 ml | 2019-01-02 | 0000-00-00 | No | No | Current |
| 0316-2045-50 | 00316204550 | 259 mL in 1 BOTTLE, PLASTIC (0316-2045-50) | 259 ml | 2005-01-03 | 0000-00-00 | No | No | Current |
| 0316-2045-60 | 00316204560 | 3785 mL in 1 JUG (0316-2045-60) | 3785 ml | 2004-02-02 | 0000-00-00 | No | No | Current |