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.
Private Label Sunscreen SPF35 40min WR RE126-202
- Manufacturer
- Swiss-American CDMO, LLC
- Effective date
- 2023-11-09
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 23:59:41
Label at a glance#
ProductPrivate Label Sunscreen SPF35 40min WR RE126-202
Active ingredientHOMOSALATE, ZINC OXIDE, OCTISALATE
Label structure10 sections
Dosage and administration
Apply liberally 15 minutes before sun exposure. Reapply after 40 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
Homosalate 9.0% Sunscreen
Zinc Oxide 10.0% Sunscreen
Octisalate 5.0% 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 40 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
Other information:
Protect this product from excessive heat and direct sun.
Inactive Ingredients
Water, dimethicone, PEG-10 dimethicone, euphorbia cerifera (Candelilla) Wax, Caprylic/Capric Trigylceride, sodium chloride, phenoxyethanol, polyhydroxystearic acid, triethoxycaprylylsilane, saccharide isomerate, ethylhexylglycerin, dl-alpha tocopheryl acetate, glycerin, disodium EDTA, xanthan gum, Gossypium herbaceum (Cotton) extract, citric acid, sodium citrate, benzyl alcohol, gluconolactone, sodium benzoate, calcium gluconate
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#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| f47a510b-6679-4664-b2d6-47b5c4afe7cc | Product name | 4 | 20260217 |
| 030ce964-9b2d-45aa-b5d3-f78ce03ef61c | Product name | 2 | 20250515 |
| 0306390c-dd77-4363-afe0-63c58088b2a1 | Product name | 1 | 20220120 |
| 503ea967-4b9c-48cf-9e87-c7975295849d | Product name | 2 | 20220120 |
| 190f2a5b-bbc8-65c7-fcb0-97891307b917 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 60232-0036-1 | Private Label Sunscreen SPF35 40min WR RE126-202 | 30 g in 1 PACKAGE | LOTION | 30 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 60232-0036 | PRIVATE LABEL SUNSCREEN SPF35 40MIN WR RE126-202 (HOMOSALATE, ZINC OXIDE SUNSCREEN) LOTION [SWISS-AMERICAN CDMO, LLC] | 1 | Current NDC, 1 package rows | 20231110_254fa69f-2413-47e8-bc9b-5b7b0b59a5c8.zip |
Products#
Every source-derived product name is available through these pages.
- Private Label Sunscreen SPF35 40min WR RE126-202
- homosalate, zinc oxide sunscreen
- HOMOSALATE
- ZINC OXIDE
- ZINC CATION
- OCTISALATE
- WATER
- EDETATE DISODIUM
- SODIUM CHLORIDE
- XANTHAN GUM
- PHENOXYETHANOL
- ETHYLHEXYLGLYCERIN
- MEDIUM-CHAIN TRIGLYCERIDES
- DIMETHICONE
- .ALPHA.-TOCOPHEROL ACETATE
- POLYHYDROXYSTEARIC ACID (2300 MW)
- TRIETHOXYCAPRYLYLSILANE
- CANDELILLA WAX
- PEG-10 DIMETHICONE (220 CST)
- SACCHARIDE ISOMERATE
- GLYCERIN
- GOSSYPIUM HIRSUTUM WHOLE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 60232-0036 | 60232-0036-1 |
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 |
|---|---|---|---|---|---|---|
| Private Label Sunscreen SPF35 40min WR RE126-202 | HOMOSALATE, ZINC OXIDE SUNSCREEN | Swiss-American CDMO, LLC | 254fa69f-2413-47e8-bc9b-5b7b0b59a5c8 | 2023-11-09 | Warnings | 60232-0036-1 60232-0036 60232003601 fe000ceb-250f-465c-81cf-ed3d78f0e7f4 254fa69f-2413-47e8-bc9b-5b7b0b59a5c8 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.