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 | 2026-10-05 | ||
| excluded package | package | 82975-101 | 82975-101-01 | D | Discontinued by firm | 2026-10-05 |
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 |
|---|---|---|---|---|---|---|
| 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 |
| Ceile tint PROTECT tinted serum SPF 50 Tan | CEILE TINT PROTECT TINTED SERUM SPF 50 TAN | LE COSMETICS INC | 58548331-38cd-8668-e063-6394a90a3362 | 2026-08-05 | Warnings | M020 |
| Ceile tint PROTECT tinted serum SPF 50 Medium Honey | CEILE TINT PROTECT TINTED SERUM SPF 50 MEDIUM HONEY | LE COSMETICS INC | 5854861a-376d-8825-e063-6394a90a8aab | 2026-08-05 | Warnings | M020 |
| Ceile tint PROTECT tinted serum SPF 50 Honey | CEILE TINT PROTECT TINTED SERUM SPF 50 HONEY | LE COSMETICS INC | 585488c5-fac5-212f-e063-6294a90a00ff | 2026-08-05 | Warnings | M020 |
| Ceile tint PROTECT tinted serum SPF 50 Medium Rich | CEILE TINT PROTECT TINTED SERUM SPF 50 MEDIUM RICH | LE COSMETICS INC | 585488af-d14f-8d71-e063-6394a90ac4f0 | 2026-08-05 | Warnings | M020 |
| Ceile tint PROTECT tinted serum SPF 50 Rich | CEILE TINT PROTECT TINTED SERUM SPF 50 RICH | LE COSMETICS INC | 58548e6d-9c82-249c-e063-6294a90a11ad | 2026-08-05 | Warnings | M020 |
| 12 Days of Derm-Loved Skincare | OCTINOXATE, ZINC OXIDE, OATMEAL, BENZOYL PEROXIDE, AVOBENZONE, OCTISALATE, OCTOCRYLENE | Rodan & Fields | a13f0275-5add-4464-88d4-ff9823274325 | 2026-08-03 | Warnings | M020 |
| Luxe Gloss Hydrating Lip Gloss SPF 35-NAKED HONEY | OCTOCRYLENE 8%, OCTISALATE 5%, TITANIUM DIOXIDE 6%, ZINC OXIDE 8% | Lale Cosmetics LLC | 581fb0cd-c55d-d562-e063-6394a90a7f11 | 2026-08-03 | Warnings | M020 |
| Manyo Air Light Moisturizing Sunscreen SPF 50 | ENSULIZOLE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Manyo Factory Corp. | 86761577-a32c-41a2-a2e3-b339b1493701 | 2026-08-03 | Warnings | M020 |
| EltaMD UV Active | ZINC OXIDE AND TITANIUM DIOXIDE SUNSCREEN | CP Skin Health Group, Inc | 39d16479-d491-4c19-aa11-674461687c7b | 2026-08-03 | Warnings | M020 |
| AMBI SKINCARE Even and Clear Daily Facial Moisturizer SPF 30 | OCTISALATE, OCTOCRYLENE, AVOBENZONE | AMBI Enterprises LLC | 99bbe9a2-bb57-4a33-b339-1649d4b319c8 | 2026-07-31 | Warnings | M020 |
| AMBI Even and Clear Facial Moisturizer SPF-30 | AVOBENZONE, OCTISALATE, OCTOCRYLENE | AMBI Enterprises LLC | 4701c0ba-4ceb-4d66-9f99-515ce33b4648 | 2026-07-31 | Warnings | M020 |
| Continuous Correction Cream | TITANIUM DIOXIDE | Baxter of California, LLC | 1cbcc648-f2e1-af60-e063-6294a90ad4bb | 2026-07-31 | 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 |