P.CALM Water Barrier Sunscreen SPF 50 Broad Spectrum
- Product NDC
- 83735-002
- 11-digit product format
- 837350002
- Labeler code
- 83735
- Product ID
- 83735-002_44ea9fb4-8e02-6969-e063-6294a90a6a94
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Homosalate, Octisalate, Octocrylene, Avobenzone
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- LIFE WITHCORPORATION Inc.
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-02-01
- Substance
- AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
- Active strength
- 2.7; 13.5; 4.5; 9 g/100mL; g/100mL; g/100mL; g/100mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- P.CALM Water Barrier Sunscreen SPF 50 Broad Spectrum
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AVOBENZONE | 2.7 g/100mL |
| OCTISALATE | 13.5 g/100mL |
| OCTOCRYLENE | 4.5 g/100mL |
| HOMOSALATE | 9 g/100mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | G63QQF2NOX, 4X49Y0596W, 5A68WGF6WM, V06SV4M95S |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 83735-002-01 | P.CALM Water Barrier Sunscreen SPF 50 Broad Spectrum | 50 mL in 1 TUBE | LOTION | 50 | | 1 |
| 83735-002-02 | P.CALM Water Barrier Sunscreen SPF 50 Broad Spectrum | 1 in 1 BOX | LOTION | 1 | | 1 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 83735-002-01 | 83735000201 | 50 mL in 1 TUBE | 50 ml | | | | Historical |
| 83735-002-02 | 83735000202 | 1 TUBE in 1 BOX (83735-002-02) / 50 mL in 1 TUBE (83735-002-01) | 1 tube | 2026-02-01 | No | No | Historical |