Indications and uses
Helps prevent sunburn. If used as directed with another sun protection measures (see Directions), decreasses the risk of skin cancer and early skin aging caused by the sun.
Sunscreen
- Manufacturer
- Oxygen Development, LLC
- Effective date
- 2023-02-03
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-05-31 23:53:43
Label at a glance#
ProductSunscreen
Active ingredientOCTISALATE, HOMOSALATE, AVOBENZONE, OCTOCRYLENE
Label structure8 sections
Dosage and administration
Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating. Reapply at least every 2 hours. Sun protection meassures: Spending time in the sun increasses your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, specially fro...
Label contents#
Full prescribing information#
Active ingredient
Avobenzone 3%
Homosalate 10%
Octisalate 5%
Octocrylene 10%
Uses
Helps prevent sunburn. If used as directed with another sun protection measures (see Directions), decreasses the risk of skin cancer and early skin aging caused by the sun.
Warnings
For external use only. Do not use on damage or broken skin. When using this product, keep out of eyes. Rinse with water to remove. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center rigth away
Directions
Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating. Reapply at least every 2 hours.
Sun protection meassures: Spending time in the sun increasses your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, specially from 10 am - 2 pm, wear long-sleeved shirts, pants, hats and sunglasses.
Inactive ingredients
Isododecane, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Butyloctyl Salicylate, Capryloyl Glycerin/Sebacic Acid Copolymer, Silica, VP/Eicosene Copolymer, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate
Package
Package
Package
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 61354-047-04 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-8b50-d83d-e063-dadaa90ab31f | Broad Spectrum Sunscreen Clear as Day SPF 46 Starface |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61354-047-01 | Sunscreen | 100 mg in 1 TUBE | GEL | 100 | 2 | |
| 61354-047-02 | Sunscreen | 1 in 1 PACKAGE | GEL | 1 | 2 | |
| 61354-047-03 | Sunscreen | 1 in 1 CARTON | GEL | 1 | 2 | |
| 61354-047-04 | Sunscreen | 1 in 1 PACKAGE | GEL | 1 | 2 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Sunscreen
- Homosalate, Octocrylene, Octisalate, Avobenzone
- OCTISALATE
- ISODODECANE
- CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S)
- DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)
- VINYLPYRROLIDONE/EICOSENE COPOLYMER
- BUTYLOCTYL SALICYLATE
- HOMOSALATE
- AVOBENZONE
- DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)
- ALUMINUM HEXAFLUOROSILICATE NONAHYDRATE
- OCTOCRYLENE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 61354-047 | 61354-047-01, 61354-047-02, 61354-047-03, 61354-047-04 |
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 |
|---|---|---|---|---|---|---|
| f3cf2641-92cd-67b2-e053-2a95a90ab73b | d7fe4990-507e-4062-e053-2a95a90ae6d9 | 2023-02-03 | Warnings | f3cf2641-92cd-67b2-e053-2a95a90ab73b d7fe4990-507e-4062-e053-2a95a90ae6d9 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.