Petroleum-Free Lip Balm
- Product NDC
- 53329-092
- 11-digit product format
- 533290092
- Labeler code
- 53329
- Product ID
- 53329-092_40c101e4-f9c5-4766-e063-6294a90aaa46
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Octinoxate and Oxybenzone
- Dosage form
- LIPSTICK
- Route
- TOPICAL
- Labeler
- Medline Industries, LP
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2010-04-01
- Substance
- OCTINOXATE; OXYBENZONE
- Active strength
- 2; 4.5 g/100g; g/100g
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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 | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded product | product | 53329-092 | I | Inactivated by FDA | excluded / ndc_excluded.zip | fb8cb913e6d1… | eb8c232b6be0… | ||
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 53329-092 | 53329-092-83 | I | Inactivated by FDA | excluded / ndc_excluded.zip | fb8cb913e6d1… | eb8c232b6be0… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Petroleum-Free Lip Balm
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| OCTINOXATE | 2 g/100g |
| OXYBENZONE | 4.5 g/100g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4Y5P7MUD51 | Internal UNII lookup |
| 95OOS7VE0Y | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 6125d98a-6fc7-4f50-924e-3b1f7ee951f4 | Available on FDA.report |
FDA-Initiated Inactive NDC Indexing#
| Effective | Related label |
|---|---|
| 2023-08-08 | 092 Curad Petroleum-Free Lip Balm |
| 2023-08-08 | 092 Curad Petroleum-Free Lip Balm |
| 2023-07-28 | 092 Curad Petroleum-Free Lip Balm |
| 2023-07-28 | 092 Curad Petroleum-Free Lip Balm |
| 2022-09-27 | 092 Curad Petroleum-Free Lip Balm |
| 2022-09-27 | 092 Curad Petroleum-Free Lip Balm |
| 2022-07-29 | 092 Curad Petroleum-Free Lip Balm |
| 2022-07-29 | 092 Curad Petroleum-Free Lip Balm |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53329-092-83 | Petroleum-Free Lip Balm | 4.2 g in 1 CONTAINER | LIPSTICK | 4.2 | 8 | |
| 53329-092-83 | Petroleum-Free Lip Balm | 1 in 1 BOX | LIPSTICK | 1 | 8 |
DailyMed Socrata Ingredients#
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 |
|---|---|---|---|---|---|---|
| Poolside Butter Screen SPF 30 Sunscreen Butter | HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE | I World LLC | ae838725-79ab-4c17-905b-d4138ad6af1f | 2026-01-05 | Warnings | M020 |
| Poolside Bronze Service Instant Bronzing Sunscreen SPF 30 | HOMOSALATE, OCTOCRYLENE, OCTISALATE, OCTINOXATE, AVOBENZONE | I World LLC | b98a9cec-3c48-4614-b091-4e59fa7d196e | 2026-01-05 | Warnings | M020 |
| Poolside Orange Creme SPF 30 Sunscreen Oil Mist | HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE | I World LLC | 5a9f8888-529d-40d7-9489-baa5ff657cb4 | 2026-01-05 | Warnings | M020 |
| Yon-Ka 50 Mineral Fluid | ZINC OXIDE | Laboratoire MULTALER Yon-Ka | 47a8c8b2-30ff-0d40-e063-6294a90ac461 | 2026-01-05 | Warnings | M020 |
| SHISEIDO FUTURE solution LX UNIVERSAL DEFENSE E | OCTISALATE, OCTOCRYLENE, AND ZINC OXIDE | SHISEIDO AMERICAS CORPORATION | 6d2f82d5-b3af-44af-b6b0-de96a4cd95fc | 2026-01-05 | Warnings | M020 |
| SHISEIDO SPORTS BB LIGHT | OCTINOXATE AND TITANIUM DIOXIDE | SHISEIDO AMERICAS CORPORATION | 260a3eab-8fe6-4259-8dcc-3706ca1f6881 | 2026-01-05 | Warnings | M020 |
| SHISEIDO VITAL PERFECTION UPLIFTING AND FIRMING DAY | AVOBENZONE, OCTINOXATE, OCTOCRYLENE, AND HOMOSALATE | SHISEIDO AMERICAS CORPORATION | 4a16dbb7-e860-4aae-8e8b-67abbe8295bd | 2026-01-05 | Warnings | M020 |
| SHISEIDO ULTIMATE SUN PROTECTOR | OCTISALATE, TITANIUM DIOXIDE, OCTOCRYLENE, AND ZINC OXIDE | SHISEIDO AMERICAS CORPORATION | c656792a-e1ed-478d-b501-9bdc92d16eca | 2026-01-05 | Warnings | M020 |
| SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 110 ALABASTER | OCTINOXATE AND TITANIUM DIOXIDE | SHISEIDO AMERICAS CORPORATION | 0a214b6b-69a7-4cb9-9095-6fcf2b6945de | 2026-01-05 | Warnings | M020 |
| SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 430 CEDAR | OCTINOXATE AND TITANIUM DIOXIDE | SHISEIDO AMERICAS CORPORATION | fb6ac681-ff74-4420-a4f6-843d5f2b6d6b | 2026-01-05 | Warnings | M020 |
| CLE DE PEAU BEAUTE PROTECTIVE FORTIFYING n | AVOBENZONE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONE | SHISEIDO AMERICAS CORPORATION | 207e2035-5f31-4745-a801-b386b040b738 | 2026-01-05 | Warnings | M020 |
| Hawaiian Blend Essential Zinc SPF 50 | ZINC OXIDE, TITANIUM DIOXIDE | The Islander Group | 47aa8605-e536-b998-e063-6394a90ad9f0 | 2026-01-05 | Warnings | M020 |
| SHISEIDO WHITE LUCENT ONMAKEUP SPOT CORRECTING SERUM NATURAL LIGHT | OCTINOXATE AND TITANIUM DIOXIDE | SHISEIDO AMERICAS CORPORATION | bf736c5b-fc33-4cd5-8d18-03929f739d76 | 2026-01-05 | Warnings | M020 |
| SHISEIDO FUTURE LX TOTAL RADIANCE FOUNDATION E Golden 1 | OCTINOXATE | SHISEIDO AMERICAS CORPORATION | 8a9294c2-3933-4f9c-b7e6-1f446f441a16 | 2026-01-05 | Warnings | M020 |
| Shiseido Future Solution LX Total Protective | AVOBENZONE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONE | SHISEIDO AMERICAS CORPORATION | 6de17911-4bce-46c9-906b-07d899a36ceb | 2026-01-05 | Warnings | M020 |
| CLE DE PEAU BEAUTE RADIANT CORRECTOR FOR EYES IVORY | OCTINOXATE AND TITANIUM DIOXIDE | SHISEIDO AMERICAS CORPORATION | c4028089-677f-4d51-9c8b-3892ff1649e0 | 2026-01-05 | Warnings | M020 |
| SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION 110 | OCTINOXATE AND TITANIUM DIOXIDE | SHISEIDO AMERICAS CORPORATION | 8a0da327-a805-4ef9-b69a-14bf7278a81a | 2026-01-05 | Warnings | M020 |
| CLE DE PEAU BEAUTE CORRECTING VEIL n | ENSULIZOLE, OCTINOXATE, AND TITANIUM DIOXIDE | SHISEIDO AMERICAS CORPORATION | fd9b42e4-6f9d-45a9-bee3-ac1bc4b35252 | 2026-01-05 | Warnings | M020 |
| SHISEIDO THE MAKEUP FOUNDATION I20 | TITANIUM DIOXIDE | SHISEIDO AMERICAS CORPORATION | 3c024fe9-2983-4857-a55a-13406158e3a9 | 2026-01-05 | Warnings | M020 |
| cle de peau BEAUTE RADIANT FLUID FOUNDATION BF10 | TITANIUM DIOXIDE | SHISEIDO AMERICAS CORPORATION | b2b55a7a-1f68-429d-ba70-5bb6c7e0d8d3 | 2026-01-05 | Warnings | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53329-092-83 | 53329009283 | 1 CONTAINER in 1 BOX (53329-092-83) / 4.2 g in 1 CONTAINER | 1 container | 2010-04-01 | 0000-00-00 | No | No | Current |