STUDIO SCULPT SPF 15 BROAD SPECTRUM FOUNDATION
- Product NDC
- 40046-0065
- 11-digit product format
- 400460065
- Labeler code
- 40046
- Product ID
- 40046-0065_efb8488a-8cde-cb54-e053-2995a90a6dca
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- OCTINOXATE and TITANIUM DIOXIDE
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- MAKEUP ART COSMETICS
- Application
- M020
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2011-09-01
- Marketing end
- 0000-00-00
- Substance
- OCTINOXATE; TITANIUM DIOXIDE
- Active strength
- 70 mg/mL; mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
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 product | product | 40046-0065 | D | Discontinued by firm | 2026-10-21 | ||
| excluded package | package | 40046-0065 | 40046-0065-1 | D | Discontinued by firm | 2026-10-21 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 40046-0065-1 | 2022-08-04 | C162847 | 48780-1 | e4f33bdf-b1e2-d8a0-e053-dadaa90a6e4e | STUDIO SCULPT SPF 15 BROAD SPECTRUM FOUNDATION |
| 40046-0065-1 | 2022-07-29 | C162847 | 48780-1 | e4f33bdf-b1e2-d8a0-e053-dadaa90a6e4e | STUDIO SCULPT SPF 15 BROAD SPECTRUM FOUNDATION |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 40046-0065 | STUDIO SCULPT SPF 15 BROAD SPECTRUM FOUNDATION (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [MAKEUP ART COSMETICS] | 7 | Legacy NDC | 20241227_ab8f5c2b-9fd8-4cd6-b6de-deef7e4bd4d2.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 |
|---|---|---|---|---|---|---|
| JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 421 | HOMOSALATE,OCTISALATE,ZINC OXIDE | Distribuidora Comercial Jafra, S.A. de C.V. | ea630f2c-49a7-4900-a0ac-b0e1c554aff9 | 2026-01-22 | Warnings | M020 |
| JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 430 | HOMOSALATE,OCTISALATE,ZINC OXIDE | Distribuidora Comercial Jafra, S.A. de C.V. | cc9c9b69-a0ea-44ac-a590-2cd241ce3162 | 2026-01-22 | Warnings | M020 |
| JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 442 | HOMOSALATE,OCTISALATE,ZINC OXIDE | Distribuidora Comercial Jafra, S.A. de C.V. | e38a10a8-73ac-4fc5-bbde-537ccb845e6f | 2026-01-22 | Warnings | M020 |
| Designer Lip Smoothie SPF 15 Lip Balm | AVOBENZONE, OCTISALATE, HOMOSALATE, PETROLATUM | Australian Gold | 6fd1bd4f-ef94-42b5-a26c-2a02718c113f | 2026-01-22 | Warnings | M020 |
| Australian Gold SPF 15 Lip Balm | OCTINOXATE, OCTOCRYLENE, OXYBENZONE, OCTISALATE, PETROLEUM JELLY | Australian Gold | 92966c2d-b61a-4f8b-a5c1-8dfb6352c82f | 2026-01-22 | Warnings | M020 |
| LEBELAGE UV SUN ULTRA SHIELD SUN SCREENLOTION 50g | AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE, OCTISALATE | DONGDONGGURIMOO CO.,LTD. | 4907eb9c-3978-27ed-e063-6394a90a9f66 | 2026-01-22 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 13C | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | be9f7608-cfaa-4b16-83dd-0580047af56c | 2026-01-21 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 15C | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 6b27df44-c441-4ae8-a1b0-a9cf2fff6f21 | 2026-01-21 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 17N | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 3c295f6b-6202-a2e1-e063-6394a90a9a60 | 2026-01-21 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 19C | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | b2eee48f-b644-403c-a57e-04a1491bc386 | 2026-01-21 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 21N | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | ebcc2c6c-a039-48d5-8c1c-5b347254c4c2 | 2026-01-21 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 21W | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 6967f8bc-3092-44a9-926a-6c11676425e5 | 2026-01-21 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 23W | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 37d4d8c1-e76b-48a3-9a13-f0543af1b28f | 2026-01-21 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 24W | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | fa5046f2-a6db-4ac3-a78f-1b5df075d7e8 | 2026-01-21 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 25N | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 0c5fc63f-1899-4406-944a-1cdcdf8b4277 | 2026-01-21 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 27C | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 58a84ecd-3f27-40fc-8e0b-e29192679e6b | 2026-01-21 | Warnings | M020 |
| ANEW SOLAIRE ACTIVE FACE AND BODY PROTECTION BROAD SPECTRUM SPF 50 SUNSCREEN | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | THE AVON COMPANY | 48e8b7f5-6977-bfae-e063-6394a90a888b | 2026-01-21 | Warnings | M020 |
| Australian Gold SPF 30 Lip Balm | AVOBENZONE, HOMOSALATE, OCTISALATE, PETROLATUM | Australian Gold | 32725ca7-ec21-4643-bdc6-278fd647b95d | 2026-01-21 | Warnings | M020 |
| Australian Gold SPF 30 Lip Balm | AVOBENZONE, HOMOSALATE, OCTISALATE, PETROLATUM | Australian Gold | e6877f7a-3aaa-4096-bcb5-eae0aa2532e5 | 2026-01-21 | Warnings | M020 |
| MINICELL UV SHIELD SUNSCREEN | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | CELINA CO., LTD. | 48eff8fa-deec-a434-e063-6294a90aa861 | 2026-01-21 | Warnings | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 40046-0065-1 | 40046006501 | 1 TUBE in 1 CARTON (40046-0065-1) > 40 mL in 1 TUBE | 1 tube | 2011-09-01 | 0000-00-00 | No | No | Current |