Hydrating Body Sunscreen
- Product NDC
- 82975-101
- 11-digit product format
- 829750101
- Labeler code
- 82975
- Product ID
- 82975-101_e8bb47dd-7d81-1647-e053-2995a90ac881
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Homosalate, Octocrylene, Octisalate, Avobenzone
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- frank body
- Application
- M020
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2022-12-31
- Marketing end
- 0000-00-00
- Substance
- AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
- Active strength
- 30 mg/mL; mg/mL; 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 | 82975-101 | D | Discontinued by firm | 2026-10-21 | ||
| excluded package | package | 82975-101 | 82975-101-01 | 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 | Dataset | Scope | Package NDC | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 82975-101-01 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 82975-101-01 | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 82975-101-01 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 82975-101-01 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 82975-101-01 | 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 |
|---|---|---|---|---|---|
| 82975-101-01 | 2025-02-01 | C162847 | 48780-1 | 2cef2736-ace4-d83d-e063-dadaa90ab31f | Hydrating Body Sunscreen |
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 |
|---|---|---|---|---|---|---|
| Vertra Pearl White Face Stick SPF 50 | PADIMATE O, TITANIUM DIOXIDE | Toshiki Pigment Co., ltd. | b7163861-7084-5adf-e053-2995a90ae199 | 2025-11-04 | Warnings | M020 |
| Land Shark SPF 8 | OCTINOXATE AND OXYBENZONE | Tropical Seas, Inc. | b5fa2883-998f-2128-e053-2995a90a5c84 | 2025-11-04 | Warnings | M020 |
| Land Shark SPF 15 | OCTOCRYLENE, OCTISALATE, AND AVOBENZONE | Tropical Seas, Inc. | b557c9c5-6ea8-1d59-e053-2995a90aff68 | 2025-11-04 | Warnings | M020 |
| Vertra Ehukai Beige Face Stick SPF 38 | TITANIUM DIOXIDE | Toshiki Pigment Co., ltd. | b71619c4-a8ef-1dda-e053-2995a90aba50 | 2025-11-04 | Warnings | M020 |
| Land Shark SPF 45 | OCTOCRYLENE, OCTINOXATE, OXYBENZONE, HOMOSALATE AND OCTISALATE | Tropical Seas, Inc. | b4cafdf1-44e1-10c0-e053-2995a90ab3dc | 2025-11-04 | Warnings | M020 |
| Reef Kids SPF 30 Oxybenzone Free | OCTOCRYLENE, OCTISALATE, AND AVOBENZONE | Tropical Seas, Inc. | e226b07a-9f44-4b17-8f26-c86dcfa5dcda | 2025-11-04 | Warnings | M020 |
| Land Shark SPF 50 | OCTOCRYLENE, OCTISALATE, AND AVOBENZONE | Tropical Seas, Inc. | b4cc95f0-d684-5331-e053-2995a90a3295 | 2025-11-04 | Warnings | M020 |
| Land Shark SPF 20 | OCTOCRYLENE, OCTISALATE, AND AVOBENZONE | Tropical Seas, Inc. | b55792e6-2ead-1fb1-e053-2995a90ac915 | 2025-11-04 | Warnings | M020 |
| Land Shark SPF 8 | OCTINOXATE AND OXYBENZONE | Tropical Seas, Inc. | b5e68448-4131-1c6c-e053-2a95a90a014a | 2025-11-04 | Warnings | M020 |
| Land Shark SPF 40 | ZINC OXIDE AND TITANIUM DIOXIDE | Tropical Seas, Inc. | d204c38c-b5d1-3511-e053-2a95a90a9dc8 | 2025-11-04 | Warnings | M020 |
| Expedition BackCountry SPF 30 | OCTOCRYLENE, OCTISALATE, AND AVOBENZONE | Tropical Seas, Inc. | b5e4e63c-3e51-0a78-e053-2a95a90abd87 | 2025-11-04 | Warnings | M020 |
| Reef Babies SPF 50 Oxybenzone Free | OCTOCRYLENE, OCTISALATE, AND AVOBENZONE | Tropical Seas, Inc. | 8cd68b09-2578-4519-b00e-e83e0e440815 | 2025-11-04 | Warnings | M020 |
| Land Shark SPF 30 | OCTOCRYLENE, OCTISALATE, AND AVOBENZONE | Tropical Seas, Inc. | b5e44be7-3a46-34e2-e053-2a95a90a9660 | 2025-11-04 | Warnings | M020 |
| Reef Kids SPF 30 Oxybenzone Free | OCTOCRYLENE, OCTISALATE, AND AVOBENZONE | Tropical Seas, Inc. | 005a9e7c-e392-4b9a-911f-d7586f7ae94e | 2025-11-04 | Warnings | M020 |
| Land Shark SPF 30 | OCTOCRYLENE, OCTISALATE, AVOBENZONE | Tropical Seas, Inc. | b559d349-2ffd-492c-e053-2995a90aab06 | 2025-11-04 | Warnings | M020 |
| Land Shark Zinky SPF 36 Pink Beach | ZINC OXIDE | Tropical Seas, Inc. | d240e6c9-d053-9924-e053-2a95a90a855a | 2025-11-04 | Warnings | M020 |
| Land Shark SPF 15 | OCTOCRYLENE, OCTISALATE, AND AVOBENZONE | Tropical Seas, Inc. | b5e49c6f-477b-aafc-e053-2a95a90a982a | 2025-11-04 | Warnings | M020 |
| Land Shark SPF 30 | OCTOCRYLENE, OCTISALATE, AVOBENZONE | Tropical Seas, Inc. | b559e03b-f5d3-bd72-e053-2995a90a31ca | 2025-11-04 | Warnings | M020 |
| Land Shark SPF 30 Clear Zinc | ZINC OXIDE AND TITANIUM DIOXIDE | Tropical Seas, Inc. | d128269b-73fa-e5f3-e053-2995a90af1ed | 2025-11-04 | Warnings | M020 |
| Land Shark SPF 50 Sport | OCTOCRYLENE, OCTISALATE, AND AVOBENZONE | Tropical Seas, Inc. | b5e40a7c-b49d-cfc3-e053-2995a90ac27e | 2025-11-04 | Warnings | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 82975-101-01 | 82975010101 | 140 mL in 1 BOTTLE, PLASTIC (82975-101-01) | 140 ml | 2022-12-31 | 0000-00-00 | No | No | Current |