Indications and uses
Helps prevent sunburn If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun.
Helps prevent sunburn If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun.
Apply liberally 15 minutes before sun exposure & again after swimming or sweating. Reapply at least every 2 hours. Children under 6 months: Ask a doctor Sun Protection Measures: To decrease your risk of skin cancer and early skin aging, regularly use a sunscreen of SPF15 or higher and other sun protective measures including: Limit time in the sun, especially from 10a.m.-2p.m. Wear long-sleeved shirts, pants, hats ...
Protect the product in this container from excessive heat and direct sunlight You may report serious adverse reactions to: Report Reaction, LLC. PO Box 22, Plainsboro, NJ 08536-0222
Drug Facts
| Active Ingredients | Purpose |
|---|---|
| Avobenzone 2% | Sunscreen |
| Octisalate 5% | Sunscreen |
| Homosalate 10% | Sunscreen |
For external use only. Do not use on damaged or broken skin. Stop use and ask a doctor if rash occurs. 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 right away.
Persea Gratissima (Avocado) Oil, Butyrospermum Parkii (Shea) Butter, Paraffin Wax, Hydrogenated Soybean Oil, Ricinus Communis (Castor) Seed Oil, Octyldodecanol, Olea Europaea (Olive) Fruit Oil, Jojoba Esters, Hydrogenated Vegetable Oil, Microcrystalline Wax, Stearic Acid, Helianthus Annuus (Sunflower) Seed Oil, Squalane, Acacia Decurrens Flower Wax, Polyglycerin-3, Rhus Verniciflua Peel Wax, Sorbitan Oleate, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Ascorbyl Palmitate, Tocopherol. May contain: Titanium Dioxide (CI 77891), Iron Oxides (CI 77491- Red), Iron Oxides (CI 77492 - Yellow), Iron Oxides (CI 77499 - Black) CI 19140 - Yellow 5, Red 28 Lake (CI 45410)
Distributed by: MDSolarSciences Corp, Stamford, CT 06902
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| ebc62596-fc97-4d03-9483-7ba095d25db7 | Product name | 1 | 20151210 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 49358-567-01 | 2023-01-30 | C162847 | 48780-1 | f386c649-b6da-0266-e053-dadaa90a7c1a | Hydrating Sheer Lip Balm SPF 30 - TRIO |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 49358-564-01 | Hydrating Sheer Lip Balm SPF 30 - TRIO | 4.2 g in 1 APPLICATOR | LIPSTICK | 4.2 g | 100 mg in 1g | 1 |
| 49358-565-01 | Hydrating Sheer Lip Balm SPF 30 - TRIO | 4.2 g in 1 APPLICATOR | LIPSTICK | 4.2 g | 50 mg in 1g | 1 |
| 49358-566-01 | Hydrating Sheer Lip Balm SPF 30 - TRIO | 4.2 g in 1 APPLICATOR | LIPSTICK | 4.2 g | 50 mg in 1g | 1 |
| 49358-567-01 | Hydrating Sheer Lip Balm SPF 30 - TRIO | 1 in 1 CARTON | KIT | 1 | 1 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 49358-564 | HYDRATING SHEER LIP BALM SPF 30 - TRIO (AVOBENZONE, OCTISALATE, AND HOMOSALATE) KIT [MDSOLARSCIENCES] | 1 | Legacy NDC | 20191001_8665d33d-0fe7-42da-b33c-0bedb3e7efd8.zip |
| 49358-565 | HYDRATING SHEER LIP BALM SPF 30 - TRIO (AVOBENZONE, OCTISALATE, AND HOMOSALATE) KIT [MDSOLARSCIENCES] | 1 | Legacy NDC | 20191001_8665d33d-0fe7-42da-b33c-0bedb3e7efd8.zip |
| 49358-566 | HYDRATING SHEER LIP BALM SPF 30 - TRIO (AVOBENZONE, OCTISALATE, AND HOMOSALATE) KIT [MDSOLARSCIENCES] | 1 | Legacy NDC | 20191001_8665d33d-0fe7-42da-b33c-0bedb3e7efd8.zip |
| 49358-567 | HYDRATING SHEER LIP BALM SPF 30 - TRIO (AVOBENZONE, OCTISALATE, AND HOMOSALATE) KIT [MDSOLARSCIENCES] | 1 | Legacy NDC, 4 package rows | 20191001_8665d33d-0fe7-42da-b33c-0bedb3e7efd8.zip |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 49358-567 | 49358-567-01 |
| 49358-564 | 49358-564-01 |
| 49358-565 | 49358-565-01 |
| 49358-566 | 49358-566-01 |
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| e070dd54-e126-47b3-ba67-975b9dc75110 | 8665d33d-0fe7-42da-b33c-0bedb3e7efd8 | 2019-08-06 | Warnings | e070dd54-e126-47b3-ba67-975b9dc75110 8665d33d-0fe7-42da-b33c-0bedb3e7efd8 |
Adverse event summaries are temporarily unavailable. Other product information remains available.