Cream
- Product NDC
- 61354-082
- Requested package NDC
- 61354-082-01
- 11-digit product format
- 613540082
- Labeler code
- 61354
- Product ID
- 61354-082_e724e10c-4f05-b03d-e053-2a95a90a754c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Zinc Oxide, Titanium Dioxide
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- Oxygen Development LLC
- Application
- M020
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2022-08-26
- Marketing end
- 0000-00-00
- Substance
- TITANIUM DIOXIDE; ZINC OXIDE
- Active strength
- 5 mg/100mg; mg/100mg
- 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 package | package | 61354-082 | 61354-082-01 | I | Inactivated by FDA | 2026-10-23 |
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 | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… |
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 |
|---|---|---|---|---|---|
| 61354-082-01 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-b0b7-d83d-e063-dadaa90ab31f | SKIN TREAT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61354-082-01 | Cream | 1 in 1 CARTON | LOTION | 1 | 1 | |
| 61354-082-01 | Cream | 100 mg in 1 TUBE | LOTION | 100 | 1 |
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 |
|---|---|---|---|---|---|---|
| FENTY SKIN HYDRA VIZOR BROAD SPECTRUM MINERAL SPF 30 SUNSCREEN MOISTURIZER FRAGRANCE-FREE | ZINC OXIDE | KENDO HOLDINGS INC | 19120c3f-8fc0-62c3-e063-6394a90a30f3 | 2025-09-30 | Warnings | M020 |
| FENTY SKIN HYDRA VIZOR SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE | KENDO HOLDINGS INC | 1d26bfb0-3c05-4a0c-9d4b-810359222730 | 2025-09-30 | Warnings | M020 |
| FENTY SKIN HYDRA VIZOR BROAD SPECTRUM MINERAL SPF 30 SUNSCREEN MOISTURIZER | ZINC OXIDE | KENDO HOLDINGS INC | fd16def1-4c88-3ad0-e053-6294a90ab088 | 2025-09-30 | Warnings | M020 |
| FENTY SKIN HYDRA VIZOR BROAD SPECTRUM MINERAL SPF 15 SUNSCREEN HAND | ZINC OXIDE | KENDO HOLDINGS INC | f92b75bd-c5b7-0320-e053-6394a90ab4c3 | 2025-09-30 | Warnings | M020 |
| OLE HENRIKSEN BANANA BRIGHT MINERAL SUNSCREEN SPF 30 | ZINC OXIDE | KENDO HOLDINGS INC | f92ae08e-0bca-4775-e053-6394a90ab3d6 | 2025-09-30 | Warnings | M020 |
| Sun Kids mineral STRAWBERRY SUNSCREEN BROAD SPECTRUM SPF 50 | ZINC OXIDE | The Natural SKN Company | 400c67aa-55a6-67ea-e063-6294a90a0213 | 2025-09-30 | Warnings | M020 |
| toty Ilumina CC Creamy Compact Refill 1C | TITANIUM DIOXIDE | Chipican LLC | f0596830-77ed-11f0-e053-2995a90a8ff5 | 2025-09-29 | Warnings | M020 |
| U V-Lamp Shield Mani-Sunscreen | ZINC OXIDE, TITANIUM DIOXIDE | GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD | 3fe7e1c3-e6cd-1420-e063-6394a90a4138 | 2025-09-28 | Warnings | M020 |
| HAWAIIAN TROPIC | AVOBENZONE,OCTISALATE,OCTOCRYLENE | Edgewell Personal Care Brands LLC | 053e76f0-8ca0-645d-e063-6394a90a01d2 | 2025-09-28 | Warnings | M020 |
| Hawaiian Tropic Mineral Translucent Sunscreen Powder SPF 30 | ZINC OXIDE | Edgewell Personal Care Brands LLC | cdc54f23-0efb-2fb4-e053-2995a90ae58b | 2025-09-28 | Warnings | M020 |
| HAWAIIAN TROPIC | AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE | Edgewell Personal Care Brands LLC | 0540017a-52ac-7972-e063-6394a90a139c | 2025-09-28 | Warnings | M020 |
| HAWAIIAN TROPIC | AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE | Edgewell Personal Care Brands LLC | 08f3b27f-b233-d406-e063-6394a90ada76 | 2025-09-28 | Warnings | M020 |
| HAWAIIAN TROPIC | AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE | Edgewell Personal Care Brands LLC | 128a3772-b9b7-0d10-e063-6294a90a3e05 | 2025-09-28 | Warnings | M020 |
| HAWAIIAN TROPIC | AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE | Edgewell Personal Care Brands LLC | 203c82a2-0131-8023-e063-6294a90aba7b | 2025-09-28 | Warnings | M020 |
| HAWAIIAN TROPIC | AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE | Edgewell Personal Care Brands LLC | 203c780a-3107-d71a-e063-6394a90aca25 | 2025-09-28 | Warnings | M020 |
| HAWAIIAN TROPIC | AVOBENZONE,OCTISALATE,OCTOCRYLENE | Edgewell Personal Care Brands LLC | 31d01fae-4085-d84a-e063-6294a90ab981 | 2025-09-28 | Warnings | M020 |
| Hawaiian Tropic | AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE | Edgewell Personal Care Brands, LLC | 3388c2fa-8082-95d4-e063-6294a90a94b8 | 2025-09-28 | Warnings | M020 |
| Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF30 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE | Kenvue Brands LLC | b10a7794-7e4f-412b-9eb2-773107ecb7fc | 2025-09-26 | Warnings | M020 |
| Black Girl Sunscreen SPF 50 | HOMOSALATE 10.00% OCTOCRYLENE 10.00% OCTISALATE 5.00% AVOBENZONE 3.00% | Black Girl Sunscreen | fed22570-e0ae-43e1-b6ce-1f0ad01684c3 | 2025-09-26 | Warnings | M020 |
| Smooth Even Glow | TINTED SUNSCREEN BROAD SPF30 | SKNVcare, LLC | 3fa48151-fcb9-3d35-e063-6394a90a2eb6 | 2025-09-25 | Warnings | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 61354-082-01 | 61354008201 | 1 TUBE in 1 CARTON (61354-082-01) > 100 mg in 1 TUBE | 1 tube | 2022-08-26 | 0000-00-00 | No | No | Current |