Prime And Protect Matte
- Product NDC
- 85363-203
- 11-digit product format
- 853630203
- Labeler code
- 85363
- Product ID
- 85363-203_4603d37b-585c-94e6-e063-6394a90a041f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Titanium Dioxide, Zinc Oxide
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Kalon Skin Studio, LLC
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-07-25
- Substance
- TITANIUM DIOXIDE; ZINC OXIDE
- Active strength
- 80; 38 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
- Prime And Protect Matte
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| TITANIUM DIOXIDE | 80 mg/g |
| ZINC OXIDE | 38 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 |
|---|---|
| 35939630-1166-1c70-e063-6294a90aac6b | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 85363-203-50 | Prime And Protect Matte | 53 g in 1 BOTTLE, PUMP | CREAM | 53 | 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 |
|---|---|---|---|---|---|---|
| natural lip balm SPF15( Birthday cake) 01 | AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 3152bd5d-474f-e392-e063-6294a90aa930 | 2025-03-27 | Warnings | M020 |
| Lip Balm SPF15 Bubble Gum Flavored | LIP BALM SPF15 BUBBLE GUM FLAVORED | LS Promotions Inc | 3152bd5d-4750-e392-e063-6294a90aa930 | 2025-03-27 | Warnings | M020 |
| natural lip balm SPF15( Cocount Pina Colada) 01 | AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 31538f32-9f71-bd40-e063-6394a90a1cd8 | 2025-03-27 | Warnings | M020 |
| Lip Balm SPF15 Birthday Cake flavored | LIP BALM SPF15 BIRTHDAY CAKE FLAVORED | LS Promotions Inc | 3153bc6a-8f60-ea37-e063-6294a90acd97 | 2025-03-27 | Warnings | M020 |
| natural lip balm SPF15( Apple pie) 01 | AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 3153e1fe-1c43-def0-e063-6294a90a6b3a | 2025-03-27 | Warnings | M020 |
| Lip Balm SPF15 Strawberry Shortcake flavored | LIP BALM SPF15 STRAWBERRY SHORTCAKE FLAVORED | LS Promotions Inc | 315402e4-c1ec-150f-e063-6294a90ae29e | 2025-03-27 | Warnings | M020 |
| natural lip balm SPF15( Vanilla) 01 | AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 3154206c-00b3-e5e3-e063-6394a90afee8 | 2025-03-27 | Warnings | M020 |
| natural lip balm SPF15( Passion Fruit) 01 | AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 31544568-c556-72b2-e063-6294a90ace91 | 2025-03-27 | Warnings | M020 |
| natural lip balm SPF15( Peppermint) 01 | AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 31548583-ecc7-2e1e-e063-6394a90a2402 | 2025-03-27 | Warnings | M020 |
| natural lip balm SPF15( strawberry) 01 | AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 3154b0f0-2025-4514-e063-6394a90a70c4 | 2025-03-27 | Warnings | M020 |
| Lip Balm SPF15 Tropical Punch Flavored | LIP BALM SPF15 TROPICAL PUNCH FLAVORED | LS Promotions Inc | 3154ae45-e075-f53b-e063-6294a90aed5b | 2025-03-27 | Warnings | M020 |
| Lip Balm SPF15 Passion Fruit flavored | LIP BALM SPF15 PASSION FRUIT FLAVORED | LS Promotions Inc | 31552e96-980c-8120-e063-6294a90af3da | 2025-03-27 | Warnings | M020 |
| natural lip balm SPF15( tropical punch) 01 | AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 315579e7-e1fb-d6f5-e063-6294a90af06a | 2025-03-27 | Warnings | M020 |
| Shea Moisture | NOURISHED AND RADIANT BROAD SPECTRUM SPF 30 SUNSCREEN FACE LOTION | Conopco d/b/a/ Unilever | 3159be1c-9678-5b1a-e063-6294a90acd08 | 2025-03-27 | Warnings | M020 |
| CeraVe Facial Moisturizing with Sunscreen Broad Spectrum SPF 30 | HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE AND ZINC OXIDE | LOreal USA Products Inc | 7d9e8c07-d295-4c8e-a52f-bdb509dc489b | 2025-03-27 | Warnings | M020 |
| Superactive Moisturizer SPF 50 Mattifying Oil plus Pore Control SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Murad, LLC | 8d89ebf5-bcd5-4fde-a7d4-059023e00f33 | 2025-03-27 | Warnings | M020 |
| Superactive Moisturizer SPF 50 Brightening SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Murad, LLC | 4ff8525a-4526-4acf-86c7-88f1f1073274 | 2025-03-26 | Warnings | M020 |
| Lip Balm SPF15 Unflavored | LIP BALM SPF15 | LS Promotions Inc | 3131632d-735c-6688-e063-6294a90a0239 | 2025-03-26 | Warnings | M020 |
| Lip Balm SPF15 Chocolate Sundae flavored | LIP BALM SPF15 | LS Promotions Inc | 3142f352-ee65-47b5-e063-6394a90ada57 | 2025-03-26 | Warnings | M020 |
| Lip Balm SPF15 Pina Colada flavored | LIP BALM SPF15 PINA COLADA FLAVORED | LS Promotions Inc | 31440153-e7ca-1327-e063-6294a90a562c | 2025-03-26 | Warnings | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 85363-203-50 | 85363020350 | 53 g in 1 BOTTLE, PUMP (85363-203-50) | 53 g | 2023-07-25 | No | No | Current |