Organys Derma Made
- Product NDC
- 83612-0282
- 11-digit product format
- 836120282
- Labeler code
- 83612
- Product ID
- 83612-0282_40c0942a-1318-6a67-e063-6294a90af373
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Zinc Oxide
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- Organys Beauty
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-07-24
- Substance
- ZINC OXIDE
- Active strength
- 132 mg/mL
- 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 | 83612-0282 | 83612-0282-1 | D | Discontinued by firm | 2026-08-11 |
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… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Organys Derma Made
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ZINC OXIDE | 132 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| SOI2LOH54Z | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 09b8b8c0-4066-9cbe-e063-6394a90aca24 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 83612-0282-1 | Organys Derma Made | 45 mL in 1 BOTTLE, PUMP | LOTION | 45 | 5 | |
| 83612-0282-2 | Organys Derma Made | 5 mL in 1 BOTTLE | LOTION | 5 | 5 | |
| 83612-0282-3 | Organys Derma Made | 45 mL in 1 TUBE | LOTION | 45 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 83612-0282 | ORGANYS DERMA MADE (ZINC OXIDE) LOTION [ORGANYS BEAUTY] | 3 | Current NDC, 3 package rows | 20241004_09b8b8c0-4066-9cbe-e063-6394a90aca24.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 |
|---|---|---|---|---|---|---|
| UV Skin Recovery SPF 50 | ZINC OXIDE | CP Skin Health Group, Inc. | 26d2683f-cfd5-50fd-e063-6394a90a7576 | 2026-08-06 | Warnings | M020 |
| AVOBENZONE, HOMOSALATE, OCTISALATE | AVOBENZONE, HOMOSALATE, OCTISALATE | Topco Associates LLC | 58636012-7e29-7206-e063-6394a90a83e9 | 2026-08-06 | Warnings, Adverse reactions | M020 |
| UV Skin Recovery SPF 50 Red Correcting | ZINC OXIDE | CP Skin Health Group, Inc. | 26e63890-d1af-d171-e063-6394a90af828 | 2026-08-06 | Warnings | M020 |
| AVOBENZONE, HOMOSALATE, OCTISALATE | AVOBENZONE, HOMOSALATE, OCTISALATE | Topco Associates LLC | 5864275d-a480-06f8-e063-6394a90aecab | 2026-08-06 | Warnings, Adverse reactions | M020 |
| Avebonzone, Homosalate, Octisalate | AVEBONZONE, HOMOSALATE, OCTISALATE | Topco Associates LLC | 5864881c-c495-1f32-e063-6294a90a1304 | 2026-08-06 | Warnings, Adverse reactions | M020 |
| Elta MD UV Daily Peptide Lip Balm SPF 40 | ZINC OXIDE | CP Skin Health Group, Inc | 945538b5-5745-42cf-b610-0018ca2ec254 | 2026-08-06 | Warnings | M020 |
| Avebonzone, Homosalate, Octisalate | AVEBONZONE, HOMOSALATE, OCTISALATE | Topco Associates LLC | 58653d79-8fff-f319-e063-6294a90af7a3 | 2026-08-06 | Warnings, Adverse reactions | M020 |
| Avebonzone, Homosalate, Octisalate | AVEBONZONE, HOMOSALATE, OCTISALATE | Topco Associates LLC | 5865f0e5-14b2-c4bf-e063-6294a90a4710 | 2026-08-06 | Warnings, Adverse reactions | M020 |
| EltaMD UV Restore | TITANIUM DIOXIDE, ZINC OXIDE SUNSCREEN | CP Skin Health Group, Inc | 37fee381-ce6b-4949-9a4a-778aa839fb84 | 2026-08-06 | Warnings | M020 |
| Neutrogena MoistureShine Lip Soother with Sunscreen SPF 20, Shine 30 | AVOBENZONE, HOMOSALATE, OCTOCRYLENE | Kenvue Brands LLC | 129ae274-0094-be5e-e063-6394a90a9801 | 2026-08-05 | Warnings | M020 |
| HERA UV PROTECTOR INVISIBLE SUNSCREEN | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | OTCM | 584c371c-24e3-5f9c-e063-6294a90a01bc | 2026-08-05 | Warnings | M020 |
| Leader Kids Sport Sunscreen SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | CARDINAL HEALTH 110, LLC. DBA LEADER | 3636693a-ba81-5d49-e063-6394a90a3006 | 2026-08-05 | Warnings | M020 |
| Ceile tint PROTECT tinted serum SPF 50 Ivory | CEILE TINT PROTECT TINTED SERUM SPF 50 IVORY | LE COSMETICS INC | 58547809-3480-1032-e063-6294a90a04c6 | 2026-08-05 | Warnings | M020 |
| Ceile tint PROTECT tinted serum SPF 50 Medium Deep | CEILE TINT PROTECT TINTED SERUM SPF 50 MEDIUM DEEP | LE COSMETICS INC | 58549160-3594-9056-e063-6394a90abf7d | 2026-08-05 | Warnings | M020 |
| Ceile tint PROTECT tinted serum SPF 50 Deep | CEILE TINT PROTECT TINTED SERUM SPF 50 DEEP | LE COSMETICS INC | 585498d4-b29c-9580-e063-6394a90adf1e | 2026-08-05 | Warnings | M020 |
| Ceile tint PROTECT tinted serum SPF 50 Fair | CEILE TINT PROTECT TINTED SERUM SPF 50 FAIR | LE COSMETICS INC | 58545633-cb36-6611-e063-6394a90a1f07 | 2026-08-05 | Warnings | M020 |
| Ceile tint PROTECT tinted serum SPF 50 Light | CEILE TINT PROTECT TINTED SERUM SPF 50 LIGHT | LE COSMETICS INC | 5853ae6b-0eaf-e614-e063-6394a90ae91a | 2026-08-05 | Warnings | M020 |
| Ceile tint PROTECT tinted serum SPF 50 Light Medium | CEILE TINT PROTECT TINTED SERUM SPF 50 LIGHT MEDIUM | LE COSMETICS INC | 585473c3-3ee9-7d84-e063-6394a90abd33 | 2026-08-05 | Warnings | M020 |
| Ceile tint PROTECT tinted serum SPF 50 Medium | CEILE TINT PROTECT TINTED SERUM SPF 50 MEDIUM | LE COSMETICS INC | 58547b48-251a-10eb-e063-6294a90ac95c | 2026-08-05 | Warnings | M020 |
| Ceile tint PROTECT tinted serum SPF 50 Medium Tan | CEILE TINT PROTECT TINTED SERUM SPF 50 MEDIUM TAN | LE COSMETICS INC | 58547e38-ae84-82ee-e063-6394a90a27d6 | 2026-08-05 | Warnings | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 83612-0282-1 | 83612028201 | 45 mL in 1 BOTTLE, PUMP | 45 ml | Historical | |||
| 83612-0282-2 | 83612028202 | 5 mL in 1 BOTTLE (83612-0282-2) | 5 ml | 2023-08-21 | Yes | No | Current |
| 83612-0282-3 | 83612028203 | 45 mL in 1 TUBE (83612-0282-3) | 45 ml | 2023-07-24 | No | No | Current |