TOTAL DEFENSE REPAIR BROAD SPECTRUM SPF 34 Sunscreen (Tinted)
- Product NDC
- 0023-5497
- 11-digit product format
- 000235497
- Labeler code
- 0023
- Product ID
- 0023-5497_c3fcfa11-8f67-4297-99b5-99bc5c8d5da8
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Octinoxate, Octisalate, Titanium dioxide and Zinc Oxide
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- Allergan, Inc.
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2015-06-15
- Substance
- OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE
- Active strength
- 75; 30; 35; 80 mg/g; mg/g; mg/g; mg/g
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- 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 | 0023-5497 | 0023-5497-25 | 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 | 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.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- TOTAL DEFENSE REPAIR BROAD SPECTRUM SPF 34 Sunscreen (Tinted)
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| OCTINOXATE | 75 mg/g |
| OCTISALATE | 30 mg/g |
| TITANIUM DIOXIDE | 35 mg/g |
| ZINC OXIDE | 80 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4Y5P7MUD51 | Internal UNII lookup |
| 4X49Y0596W | Internal UNII lookup |
| 15FIX9V2JP | Internal UNII lookup |
| SOI2LOH54Z | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 6a996e03-907f-4e6a-b232-0892b86956b0 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| d1c9d1af-bddd-448d-86f7-69052b7d5b47 | Product name | 1 | 20220627 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0023-5497-01 | TOTAL DEFENSE REPAIR BROAD SPECTRUM SPF 34 Sunscreen (Tinted) | 28.4 g in 1 TUBE | LOTION | 28.4 | 7 | |
| 0023-5497-01 | TOTAL DEFENSE REPAIR BROAD SPECTRUM SPF 34 Sunscreen (Tinted) | 1 in 1 CARTON | LOTION | 1 | 7 | |
| 0023-5497-08 | TOTAL DEFENSE REPAIR BROAD SPECTRUM SPF 34 Sunscreen (Tinted) | 1 in 1 CARTON | LOTION | 1 | 7 | |
| 0023-5497-08 | TOTAL DEFENSE REPAIR BROAD SPECTRUM SPF 34 Sunscreen (Tinted) | 227 g in 1 TUBE | LOTION | 227 | 7 | |
| 0023-5497-23 | TOTAL DEFENSE REPAIR BROAD SPECTRUM SPF 34 Sunscreen (Tinted) | 1 in 1 CARTON | LOTION | 1 | 7 | |
| 0023-5497-23 | TOTAL DEFENSE REPAIR BROAD SPECTRUM SPF 34 Sunscreen (Tinted) | 65 g in 1 TUBE | LOTION | 65 | 7 | |
| 0023-5497-25 | TOTAL DEFENSE REPAIR BROAD SPECTRUM SPF 34 Sunscreen (Tinted) | 6 in 1 CARTON | LOTION | 6 | 7 | |
| 0023-5497-25 | TOTAL DEFENSE REPAIR BROAD SPECTRUM SPF 34 Sunscreen (Tinted) | 7.08 g in 1 TUBE | LOTION | 7.08 | 7 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0023-5497 | TOTAL DEFENSE REPAIR BROAD SPECTRUM SPF 34 SUNSCREEN (TINTED) (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [ALLERGAN, INC.] | 7 | Current NDC, Legacy NDC, 8 package rows | 20241222_6a996e03-907f-4e6a-b232-0892b86956b0.zip |
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 |
|---|---|---|---|---|---|---|
| ULTRALIGHT AGE DEFENSE SPF 50 | ZINC OXIDE | Guangzhou Origin Beauty Cosmetics Co., Ltd. | 4e36a743-7906-2b7b-e063-6294a90af314 | 2026-03-29 | Warnings | M020 |
| Stay Put Sunscreen SPF 30 | OCTINOXATE 7.50% OCTISALATE 5.00% OXYBENZONE 4.00% HOMOSALATE 10.00% | Sawyer Products Inc | 7ecba495-a912-4697-8287-2e5836e610e1 | 2026-03-27 | Warnings | M020 |
| UV SOLUTIONS BRIGHTENING TINTED BROAD SPECTRUM SPF 50 SUNSCREEN NIACINAMIDE ANTIOXIDANTS DARK SHADE | TITANIUM DIOXIDE AND ZINC OXIDE | CLINIQUE LABORATORIES LLC | 4e0bd355-99c6-8cf4-e063-6294a90ab4b3 | 2026-03-27 | Warnings | M020 |
| Vacation X AZ Lemon Tea Lip Balm SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | Vacation INC. | 61c48acc-f589-40d3-b289-b777db5551db | 2026-03-27 | Warnings | M020 |
| Truly Solar Baby Suncreen SPF 45 | HOMOSALATE 15% OCTISALATE 5% OCTOCRYLENE 10% AVOBENZONE 3% | Truly Beauty, Inc | 38e6c6fc-d8b9-4196-96c7-0f6d5d06da02 | 2026-03-26 | Warnings | M020 |
| burnd | HOMOSALATE, OCTINOXATE, ZINC OXIDE | BURND LLC | 31cf923e-fdde-790b-e063-6294a90a60ee | 2026-03-26 | Warnings | M020 |
| SUNNYSIDEKICK UVA/UVB Broad Spectrum SPF 30 Brush-On Mineral | ZINC OXIDE, TITANIUM DIOXIDE | Classic Cosmetics LLC | 4df3b8c0-71bc-acdd-e063-6394a90a35c0 | 2026-03-26 | Warnings | M020 |
| COSRX | VITAMIN E VITALIZING SUNSCREEN | COSRX inc. | 4df77564-9da0-7e48-e063-6294a90a5e6b | 2026-03-26 | Warnings | M020 |
| Mentholatum Natural Ice Protect Plus SPF 30 Protect Plus SPF 30 | AVOBENZONE, DIMETHICONE, OCTINOXATE, OCTISALATE | The Mentholatum Company | 3804a14b-be7c-a973-e063-6294a90ac7fc | 2026-03-25 | Warnings | M020 |
| Softlips Oasis Pineapple Coconut | DIMETHICONE, OXYBENZONE, OCTINOXATE | The Mentholatum Company | c504463a-28bf-4161-875f-ef73520931c5 | 2026-03-25 | Warnings | M020 |
| Mentholatum Natural Ice Cherry, SPF 15 Cherry | DIMETHICONE, OCTINOXATE, OCTISALATE | The Mentholatum Company | 37f2c3a6-7790-c8ec-e063-6294a90ace22 | 2026-03-25 | Warnings | M020 |
| Mentholatum Natural Ice - Original, SPF 15 Original | DIMETHICONE, OCTINOXATE, OCTISALATE | The Mentholatum Company | 37dc44aa-17b2-8721-e063-6294a90a34f6 | 2026-03-25 | Warnings | M020 |
| ISNTREE HYALURONIC ACID DAILY SUNGEL | AVOBENZONE, HOMOSALATE, OCTISALATE | ISNTREE Inc. | 0ef5d5ce-3bdf-dffc-e063-6394a90aad54 | 2026-03-25 | Warnings | M020 |
| Silkscreen Sheer Tint Mineral Light-Medium | TITANIUM DIOXIDE, ZINC OXIDE | Curology | 4ddbe349-6880-a5fc-e063-6294a90a275c | 2026-03-25 | Warnings | M020 |
| AXIS-Y Complete No-Stress Physical Sunscreen V.3 | ZINC OXIDE | Asia Master Trade Co.,Ltd | 1f310fb1-185a-b467-e063-6294a90a72fe | 2026-03-25 | Warnings | M020 |
| BANANA BOAT | TITANIUM DIOXIDE,ZINC OXIDE | Edgewell Personal Care Brands LLC | 4e0450ca-147a-91d7-e063-6394a90ae73b | 2026-03-25 | Warnings | M020 |
| Mentholatum Natural Ice Original | DIMETHICONE, OCTINOXATE, OCTISALATE | The Mentholatum Company | 29220eaa-87cb-4ebe-87db-d36288b3a9e4 | 2026-03-24 | Warnings | M020 |
| Sport Sunscreen SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE | Amazon.com Services LLC | f54c617f-794e-413b-b898-4a06622b4bee | 2026-03-24 | Warnings, Adverse reactions | M020 |
| VITAL PERFECTION UPLIFTING AND FIRMING ADVANCED DAY | AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE | Shiseido Americas Corporation | 7b2d15c1-b9e1-4347-b138-9883f78822b3 | 2026-03-24 | Warnings | M020 |
| Sunscreen SPF 50 | SUNSCREEN SPF 50 | Guangzhou Ariel Biotech Co., Ltd. | 4dd05620-30a3-9cea-e063-6294a90af18b | 2026-03-24 | Warnings | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0023-5497-01 | 00023549701 | 1 TUBE in 1 CARTON (0023-5497-01) / 28.4 g in 1 TUBE | 1 tube | 2015-06-15 | 0000-00-00 | No | No | Current |
| 0023-5497-08 | 00023549708 | 1 TUBE in 1 CARTON (0023-5497-08) / 227 g in 1 TUBE | 1 tube | 2015-06-15 | 0000-00-00 | No | No | Current |
| 0023-5497-23 | 00023549723 | 1 TUBE in 1 CARTON (0023-5497-23) / 65 g in 1 TUBE | 1 tube | 2015-06-15 | 0000-00-00 | No | No | Current |
| 0023-5497-25 | 00023549725 | 6 TUBE in 1 CARTON (0023-5497-25) > 7.08 g in 1 TUBE | 6 tube | 2015-06-15 | 0000-00-00 | No | No | Current |