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 | 2026-10-21 | |
| excluded package | package | 0316-2045 | 0316-2045-45 | D | Discontinued by firm | 2026-10-21 | |
| excluded package | package | 0316-2045 | 0316-2045-50 | D | Discontinued by firm | 2026-10-21 | |
| excluded package | package | 0316-2045 | 0316-2045-60 | D | Discontinued by firm | 2026-10-21 |
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 |
|---|---|---|---|---|---|---|
| Coppertone Kids Sport Sunscreen SPF 100 | AVOBENZONE 3%, HOMOSALATE 15%, OCTINOXATE 2% OCTISALATE 5%, OCTOCRYLENE 10%, OXYBENZONE 6% | Beiersdorf Inc | c068a6e7-260f-0766-e053-2995a90a422f | 2025-12-31 | Warnings | M020 |
| Coppertone Sport Suncreen SPF 50 | AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5% | Beiersdorf Inc | cc43f433-51ff-ed6a-e053-2a95a90ad3c5 | 2025-12-31 | Warnings | M020 |
| Coppertone Sport Mineral Sunscreen SPF 50 | ZINC OXIDE | Beiersdorf Inc | b5bb6eb6-3356-e2a5-e053-2995a90aa684 | 2025-12-31 | Warnings | M020 |
| Coppertone Limited Edition Sunscreen SPF 50 | AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5% | Beiersdorf Inc | ccbf7795-e153-1a43-e053-2a95a90ad4b6 | 2025-12-31 | Warnings | M020 |
| Eucerin Advanced Hydration SPF 50 Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Beiersdorf Inc | cd9cbdb4-42f1-3063-e053-2a95a90a08aa | 2025-12-31 | Warnings | M020 |
| Eucerin Baby Sensitive Mineral SPF 50 Sunscreen | ZINC OXIDE | Beiersdorf Inc | cdb19c82-9845-eabc-e053-2a95a90a31f7 | 2025-12-31 | Warnings | M020 |
| Eucerin Advance Hydration Sunscreen SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Beiersdorf Inc | cd61e4d7-776d-8d84-e053-2995a90a4819 | 2025-12-31 | Warnings | M020 |
| Eucerin Oil-Control SPF 50 Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Beiersdorf Inc | cda04484-ba84-2276-e053-2a95a90a41c8 | 2025-12-31 | Warnings | M020 |
| Coppertone Kids Sunscreen SPF 60 | AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10% | Beiersdorf Inc | 240dd76a-8f39-caec-e063-6294a90abbbc | 2025-12-31 | Warnings | M020 |
| Coppertone Protect and Tan SPF 30 | AVOBENZONE 3%, HOMOSALATE 14%, OCTISALATE 4.5%, OCTOCRYLENE 9% | Beiersdorf Inc | d3994886-2ebe-a9d2-e053-2995a90aaf9a | 2025-12-31 | Warnings | M020 |
| Coppertone Waterbabies Pure and Simple Sunscreen SPF 50 | AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9% | Beiersdorf Inc | d3d471b8-7430-98b0-e053-2995a90aba4b | 2025-12-31 | Warnings | M020 |
| Coppertone Sport Sunscreen SPF 60 | AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10% | Beiersdorf Inc | 241f78be-0d7f-c5ca-e063-6294a90a997a | 2025-12-31 | Warnings | M020 |
| Coppertone Protect and Tan Sunscreen SPF 45 | AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10% | Beiersdort Inc | d39a009d-1f33-88bb-e053-2a95a90a03a0 | 2025-12-31 | Warnings | M020 |
| Coppertone Sport Sunscreen SPF 30 | AVOBENZONE 2%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 7% | Beiersdorf Inc | d460d669-42df-46c0-e053-2a95a90ad77b | 2025-12-31 | Warnings | M020 |
| Coppertone Tanning Sunscreen SPF 8 | AVOBENZONE 2%, HOMOSALATE 5%, OCTISALATE 4.5%, OCTOCRYLENE 3% | Beiersdorf Inc | d370094c-3373-594b-e053-2a95a90a114a | 2025-12-31 | Warnings | M020 |
| Coppertone Tanning Sunscreen SPF 15 | (TO DELIVER) AVOBENZONE 2%, OCTISALATE 4.5%, OCTOCRYLENE 7% | Beiersdorf Inc | 0a5a35be-9e24-18dd-e063-6394a90a097f | 2025-12-31 | Warnings | M020 |
| Coppertone Sport Sunscreen SPF 50 | AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5% | Beiersdorf Inc | d462081f-f082-5df2-e053-2995a90aa1d9 | 2025-12-31 | Warnings | M020 |
| Coppertone Waterbabies Pure and Simple Sunscreen SPF 50 | AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9% | Beiersdorf Inc | d3e66496-bc3c-d189-e053-2a95a90a06b6 | 2025-12-31 | Warnings | M020 |
| Coppertone Kids Sunscreen SPF 50 | AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5% | Beiersdorf Inc. | c05388dc-4282-ee79-e053-2a95a90a376a | 2025-12-31 | Warnings | M020 |
| Coppertone Glow Sunscreen SPF 50 | AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9% | Beiersdorf Inc | b60dcbd1-42d0-646f-e053-2a95a90a497d | 2025-12-31 | 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 |