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; OCTISALATE; OCTOCRYLENE; HOMOSALATE
- Active strength
- 2.7; 4.5; 9; 13.5 g/100mL; g/100mL; g/100mL; g/100mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- 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
- P.CALM Water Barrier Sunscreen SPF 50 Broad Spectrum
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| AVOBENZONE | 2.7 g/100mL |
| OCTISALATE | 4.5 g/100mL |
| OCTOCRYLENE | 9 g/100mL |
| HOMOSALATE | 13.5 g/100mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| G63QQF2NOX | Internal UNII lookup |
| 4X49Y0596W | Internal UNII lookup |
| 5A68WGF6WM | Internal UNII lookup |
| V06SV4M95S | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 44ea9fb4-8e01-6969-e063-6294a90a6a94 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 77dc03a4-fbfc-e6a3-fe95-285bbae40d75 | Product name | 2 | 20250814 |
DailyMed Package Descriptions#
| 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 |
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 |
|---|---|---|---|---|---|---|
| Eucerin Sensitive Mineral SPF 50 Sunscreen | ZINC OXIDE | Beiersdorf Inc | cdb25154-e4e3-efc7-e053-2a95a90a2df6 | 2025-11-10 | Warnings | M020 |
| ESSENCE BY CATHERINE HINDS Broad Spectrum MINERAL PROTECTION SPF 50 | ZINC OXIDE | Catherine Hinds Company, Inc. | 956e6643-51c9-49c4-bd68-f5ee1b0ae4e0 | 2025-11-10 | Warnings | M020 |
| GoodSense SPF 50 Sunscreen | AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10% | Geiss, Destin, & Dunn, Inc. | c85d59a1-6ae1-bb2e-e053-2995a90af20e | 2025-11-09 | Warnings | M020 |
| GoodSense SPF 30 Sunscreen | AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 6% | Geiss, Destin, & Dunn, Inc. | c85c5d2b-35f6-2fd5-e053-2995a90a4a53 | 2025-11-09 | Warnings | M020 |
| Walgreens SPF 50 Tinted Mineral Fluid | TITANIUM DIOXIDE | Walgreens | 345918e3-95f8-404c-e063-6394a90a3fca | 2025-11-09 | Warnings | M020 |
| Gold Dynamics Skin Boosting Moisturizer Broad Spectrum SPF 15 Sunscreen | AVOBENZONE, OXYBENZONE, OCTISALATE, OCTINOXATE | Distribuidora Comercial Jafra, S.A. de C.V. | ad6646c7-c6aa-4610-a0c7-ddd1ddd13cde | 2025-11-07 | Warnings | M020 |
| e.l.f Camo Semi-Matte CC Cream SPF 30 Deep 500 W | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | d690d5d1-e1fa-404f-a17e-7b97be17b44a | 2025-11-07 | Warnings | M020 |
| e.l.f Camo Semi-Matte CC Cream SPF 30 Deep 510 C | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | 2fbdeff7-4880-49ef-bb4d-e033d18e0459 | 2025-11-07 | Warnings | M020 |
| e.l.f Camo Semi-Matte CC Cream SPF 30 Deep 540 N | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | 6a86e5fd-6736-45e0-aa7d-d268fdaed4f8 | 2025-11-07 | Warnings | M020 |
| e.l.f Camo Semi-Matte CC Cream SPF 30 Deep 560 C | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | 42a3625f-5c58-4ec5-895f-b14f74428271 | 2025-11-07 | Warnings | M020 |
| e.l.f Camo Semi-Matte CC Cream SPF 30 Tan 415 C | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | 8e14fe81-cf7f-4a81-afec-e6c8466179c9 | 2025-11-07 | Warnings | M020 |
| e.l.f Camo Semi-Matte CC Cream SPF 30 Tan 425 N | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | 7dd9f4cb-78d8-4edc-a63c-d4a02930a0f8 | 2025-11-07 | Warnings | M020 |
| e.l.f Camo Semi-Matte CC Cream SPF 30 Tan 450 N | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | 8acb660f-94bd-4c4f-b0c1-3682cf8ed543 | 2025-11-07 | Warnings | M020 |
| e.l.f Camo Semi-Matte CC SPF 30 Fair 150 C | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | fad2bec7-c5f4-45f4-aff4-a5022033cb6a | 2025-11-07 | Warnings | M020 |
| e.l.f Camo Semi-Matte CC SPF 30 Medium 355 W | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | 39856c69-84fb-4b12-a713-8912263e42b1 | 2025-11-07 | Warnings | M020 |
| e l f Holy Hydration Face SPF 30 Sunscreen, | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc | 44a8028b-731d-4561-b2e3-ee9738ad8d30 | 2025-11-07 | Warnings | M020 |
| e l f Sun Boss Gloss SPF 25 Sunscreen Its your Mauve | ZINC OXIDE | e.l.f. Cosmetics, Inc. | bce21361-c92c-40ad-a373-db3b83b15b8a | 2025-11-07 | Warnings | M020 |
| e l f Whoa Glow Broad Spectrum SPF 30 Sunscreen Sheer Bronze Shimmer Sunburst | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc | 49d912c7-259a-487d-a523-b14031bfaab6 | 2025-11-07 | Warnings | M020 |
| e l f Whoa Glow Broad Spectrum SPF 30 Sunscreen Sheer Champagne Shimmer Sunlight | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | 1e9bdd41-69c3-4034-bd9e-b4bc5a1bd50d | 2025-11-07 | Warnings | M020 |
| e l f Whoa Glow Broad Spectrum SPF 30 Sunscreen Sheer Peach Shimmer Sunbeam | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | f818f524-0263-4f89-b4f3-4dd83d688e7e | 2025-11-07 | Warnings | M020 |
Packages#
| 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 | Current |