Indications and uses
Helps prevent sunburn. If used as directed with other sun protection measure (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
Physical Sunscreen SPF50 80 min WR 159-100
- Manufacturer
- Swiss-American CDMO, LLC
- Effective date
- 2023-11-09
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-05-31 23:59:40
Label at a glance#
ProductPhysical Sunscreen SPF50 80 min WR 159-100
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure10 sections
Dosage and administration
Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating, immediately after towel drying and at least every 2 hours. Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad-spectrum SPF of 15 or higher and other sun protection measures including: limit time in the...
Contacts and useful links#
Label contents#
Full prescribing information#
Warnings
For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a physician if rash occurs. If product is swallowed get medical help or contact a Poison Control Center right away.
Active Ingredients
Titanium Dioxide 4.23% Sunscreen
Zinc Oxide 18.28% Sunscreen
Uses
Helps prevent sunburn. If used as directed with other sun protection measure (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
Uses
Helps prevent sunburn. If used as directed with other sun protection measure (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
Directions
Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating, immediately after towel drying and at least every 2 hours. Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad-spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 am to 2 pm. Wear long-sleeve shirts, pants, hats, and sunglasses. Children under 6 months: ask a physician.
Keep out of reach of children
Keep out of reach of children
Inactive ingredients
Water, C15-19 Alkane, Octyldodecyl Neopentanoate, Caprylic/Capric Triglyceride, Butyloctyl Salicylate, Dimethicone, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Glycerin, Hydrogenated Polyisobutene, Polyhydroxystearic Acid, Sodium Chloride, Triethoxycaprylylsilane, Silica, Saccharide Isomerate, Hydroxyacetophenone, Niacinamide, Sorbitan Olivate, Glyceryl Behenate, 1,2-Hexanediol, Caprylyl Glycol, Tocopheryl Acetate, Disodium EDTA, Scenedesmus Rubescens Extract, Gellan Gum, Polygonum Aviculare Extract, citric acid, sodium citrate, potassium sorbate, sodium benzoate
Other information
Protect this product from excessive heat and direct sun.
Questions
Call toll free 1-866-416-2366
Labeling
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| ZINC CATION Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 60232-0044-1 | Physical Sunscreen SPF50 80 min WR 159-100 | 90 g in 1 PACKAGE | LOTION | 90 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 60232-0044 | PHYSICAL SUNSCREEN SPF50 80 MIN WR 159-100 (TITANIUM DIOXIDE, TITANIUM DIOXIDE SUNSCREEN) LOTION [SWISS-AMERICAN CDMO, LLC] | 2 | Current NDC, 1 package rows | 20231110_0cca7b65-e24a-429c-b157-5f4e343424ab.zip |
Products#
Every source-derived product name is available through these pages.
- Physical Sunscreen SPF50 80 min WR 159-100
- titanium dioxide, titanium dioxide sunscreen
- TITANIUM DIOXIDE
- ZINC OXIDE
- ZINC CATION
- WATER
- C15-19 ALKANE
- OCTYLDODECYL NEOPENTANOATE
- BUTYLOCTYL SALICYLATE
- DIMETHICONE
- POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE
- GLYCERIN
- POLYHYDROXYSTEARIC ACID (2300 MW)
- SODIUM CHLORIDE
- TRIETHOXYCAPRYLYLSILANE
- SACCHARIDE ISOMERATE
- HYDROXYACETOPHENONE
- NIACINAMIDE
- SORBITAN OLIVATE
- 1,2-HEXANEDIOL
- CAPRYLYL GLYCOL
- EDETATE DISODIUM
- PENTYLENE GLYCOL
- GELLAN GUM (LOW ACYL)
- POLYGONUM AVICULARE WHOLE
- ANHYDROUS CITRIC ACID
- SODIUM CITRATE
- POTASSIUM SORBATE
- SODIUM BENZOATE
- MEDIUM-CHAIN TRIGLYCERIDES
- HYDROGENATED POLYBUTENE (1300 MW)
- SILICON DIOXIDE
- GLYCERYL MONOBEHENATE
- .ALPHA.-TOCOPHEROL ACETATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 60232-0044 | 60232-0044-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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 |
|---|---|---|---|---|---|---|
| Physical Sunscreen SPF50 80 min WR 159-100 | TITANIUM DIOXIDE, TITANIUM DIOXIDE SUNSCREEN | Swiss-American CDMO, LLC | 0cca7b65-e24a-429c-b157-5f4e343424ab | 2023-11-09 | Warnings | 60232-0044-1 60232-0044 60232004401 6943f1b5-dc1d-49af-a51e-4c4bb778c45b 0cca7b65-e24a-429c-b157-5f4e343424ab |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.