Tinted Lip Balm
- Product NDC
- 85362-212
- 11-digit product format
- 853620212
- Labeler code
- 85362
- Product ID
- 85362-212_4603db8e-2444-c231-e063-6294a90a31bf
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Titanium Dioxide, Zinc Oxide
- Dosage form
- STICK
- Route
- TOPICAL
- Labeler
- Goldberg, Howard S MD Inc
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-01-07
- Substance
- TITANIUM DIOXIDE; ZINC OXIDE
- Active strength
- 40; 55 mg/g; mg/g
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
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
- Tinted Lip Balm
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| TITANIUM DIOXIDE | 40 mg/g |
| ZINC OXIDE | 55 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 15FIX9V2JP | Internal UNII lookup |
| SOI2LOH54Z | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 3598205d-2e87-9292-e063-6294a90a1f2a | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c5cd4727-ac49-4409-82b1-5bd8006c3ec7 | Product name | 1 | 20171122 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 85362-212-45 | Tinted Lip Balm | 4.5 g in 1 CYLINDER | STICK | 4.5 | 2 |
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 |
|---|---|---|---|---|---|---|
| Sun Bum Road Tripper Mineral - Mineral Sunscreen Broad Spectrum SPF 30 | ZINC OXIDE | Sun Bum, LLC | 3dd7b0af-dc37-1701-e063-6294a90a65c3 | 2025-09-02 | Warnings | M020 |
| toty Ilumina CC Creamy Compact 6N | TITANIUM DIOXIDE | Chipican LLC | 3da732e7-19b0-3195-e063-6394a90a9a0c | 2025-09-01 | Warnings | M020 |
| PHOFAY Matte Sunscreen Liquid Foundation SPF 30 4 | ENSULIZOLE ,HOMOSALATE,OCTINOXATE,TITANIUM DIOXIDE | Hangzhou Jingshen Trading Co., Ltd. | 3dba1360-f70f-e450-e063-6394a90a8c9f | 2025-09-01 | Warnings | M020 |
| TOCOBO Cotton Airy Sun Stick | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | PICTON CO., Ltd. | 2f7e7ef4-c3ac-4c26-e063-6394a90a9e42 | 2025-09-01 | Warnings | M020 |
| TOCOBO Bio Watery Sun Screen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | PICTON CO., Ltd. | 3a7db6f4-66fd-4473-e063-6394a90a886e | 2025-09-01 | Warnings | M020 |
| TOCOBO Bio Watery Sun Screen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | PICTON CO., Ltd. | 2f7eb413-ff49-711d-e063-6394a90ad6dc | 2025-09-01 | Warnings | M020 |
| Ocean Potion Suncare Mineral 30 Essential Scent of Sunshine Zinc Oxide Sunscreen | ZINC OXIDE | GNL BRANDS INTERNATIONAL, LLC | 3db1cf3e-0640-6821-e063-6294a90a7036 | 2025-08-31 | Warnings | M020 |
| Purpose Dual Treatment SPF 10 | OCTINOXATE 7.5%, OCTISALATE 5%, OXYBENZONE 3% | Elysium Consumer Healthcare LLC | 3d7fe711-a671-df30-e063-6394a90afbbf | 2025-08-29 | Warnings | M020 |
| Good Weather Skin The One Daily Sun Warm Glow SPF 30 | ZINC OXIDE | Good Weather Inc. | 3d83aaa5-0e4e-928a-e063-6294a90a24da | 2025-08-29 | Warnings | M020 |
| Dolce and Gabbana Everlast Foundation SPF 20 33N Deep | OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE | Dolce & Gabbana Beauty S.R.L | e249507c-d536-4c1d-a99d-857ca1e833d8 | 2025-08-29 | Warnings | M020 |
| Dolce and Gabbana Everlast Foundation SPF 20 32W Medium Deep | OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE | Dolce & Gabbana Beauty S.R.L | ba99edea-bf68-4118-8bb7-ea40322db46a | 2025-08-29 | Warnings | M020 |
| Dolce and Gabbana Everlast Foundation SPF 20 34W Deep | OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE | Dolce & Gabbana Beauty S.R.L | 3a239897-9850-417f-8c00-e810a52540c1 | 2025-08-29 | Warnings | M020 |
| Dolce and Gabbana Everlast Foundation SPF 20 36N Deep | OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE | Dolce & Gabbana Beauty S.R.L | c495afc3-6486-4652-b743-958f28eccaca | 2025-08-29 | Warnings | M020 |
| Dolce and Gabbana Everlast Foundation SPF 20 35W Deep | OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE | Dolce & Gabbana Beauty S.R.L | 5440ed13-b07e-4c81-a407-d9ac68eaa483 | 2025-08-29 | Warnings | M020 |
| Dolce and Gabbana Everlast Foundation SPF 20 37W Deep | OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE | Dolce & Gabbana Beauty S.R.L | 9b2c4567-fde7-4b76-9988-b2cba2d3747e | 2025-08-29 | Warnings | M020 |
| Neutrogena Hydro Boost Hyaluronic Acid Moisturizer Broad Spectrum SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | Kenvue Brands LLC | 3abd12f4-cbe3-4dd7-e063-6394a90a50a2 | 2025-08-28 | Warnings | M020 |
| Sun Bum 15 Premium Moisturizing Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Sun Bum, LLC | 3d49b054-9f49-17d1-e063-6294a90a757a | 2025-08-28 | Warnings | M020 |
| PHOFAY Matte Sunscreen Liquid Foundation SPF 30 2 | ENSULIZOLE,HOMOSALATE,OCTINOXATE,TITANIUM DIOXIDE | Hangzhou Jingshen Trading Co., Ltd. | 3d55291c-9d4c-85c3-e063-6394a90af330 | 2025-08-27 | Warnings | M020 |
| PHOFAY Matte Sunscreen Liquid Foundation SPF 30 3 | ENSULIZOLE ,HOMOSALATE,OCTINOXATE,TITANIUM DIOXIDE | Hangzhou Jingshen Trading Co., Ltd. | 3d565612-ade5-bfb3-e063-6294a90a0c65 | 2025-08-27 | Warnings | M020 |
| Jack Black Double Duty | AVOBENZONE OCTOCRYLENE | Jack Black L.L.C. | 36d81d6d-4f9b-692d-e063-6294a90ad559 | 2025-08-27 | Warnings | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 85362-212-45 | 85362021245 | 4.5 g in 1 CYLINDER (85362-212-45) | 4.5 g | 2025-01-07 | No | No | Current |