![LUMINOUS INTENSIVE HAND TREATMENT SPF 25 (AVOBENZONE, OCTINOXATE, AND OCTISALATE) LOTION [ERNO LASZLO, INC.]](https://medic.hrt.org//dailymed/images/6285f1f0-fd0c-4094-9f64-e9bf1bce8b85/luminous-01.jpg)
| NDC | 57913-2525-9 |
| Set ID | 6285f1f0-fd0c-4094-9f64-e9bf1bce8b85 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Erno Laszlo, Inc. |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
-
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
- Warnings
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Directions
Apply liberally 15 minutes before sun exposure
- reapply: after 40 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours
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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 a.m. - 2 p.m.
- wear long-sleeve shirts, pants, hats, and sunglasses
- children under 6 months: Ask a doctor
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Inactive Ingredients
Water, Butyrospermum Parkii (Shea Butter), Octyldodecyl Neopentanoate, Cetyl Alcohol, Propylene Glycol, Glyceryl Stearate, PEG-100 Stearate, Cyclomethicone, Steareth-20, Ceteth-20, Persea Gratissima (Avocado) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Taraktogenos Kurzii Seed Oil, Glycerin, Centella Asiatica Extract, Echinacea Purpurea Extract, Saxifraga Sarmentosa Extract, Vitis Vinifera (Grape) Fruit Extract, Morus Nigra Root Extract, Scutellaria Baicalensis Root Extract, Algae Extract, Fragrance, Carbomer, Phenoxyethanol, Isopropylparaben, Isobutylparaben, Butylparaben, Sodium Hydroxide.
- Other information
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 100 mL Tube Carton
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INGREDIENTS AND APPEARANCE
LUMINOUS INTENSIVE HAND TREATMENT SPF 25
avobenzone, octinoxate, and octisalate lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57913-2525 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 20 mg in 1 mL Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 75 mg in 1 mL Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SHEA BUTTER (UNII: K49155WL9Y) OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T) CETYL ALCOHOL (UNII: 936JST6JCN) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) CYCLOMETHICONE (UNII: NMQ347994Z) STEARETH-20 (UNII: L0Q8IK9E08) CETETH-20 (UNII: I835H2IHHX) AVOCADO OIL (UNII: 6VNO72PFC1) JOJOBA OIL (UNII: 724GKU717M) HYDNOCARPUS KURZII SEED OIL (UNII: N757YEZ18Q) GLYCERIN (UNII: PDC6A3C0OX) CENTELLA ASIATICA (UNII: 7M867G6T1U) ECHINACEA PURPUREA (UNII: QI7G114Y98) SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H) WINE GRAPE (UNII: 3GOV20705G) MORUS NIGRA ROOT (UNII: 033456LFG1) SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S) PHENOXYETHANOL (UNII: HIE492ZZ3T) ISOPROPYLPARABEN (UNII: A6EOX47QK0) ISOBUTYLPARABEN (UNII: 0QQJ25X58G) BUTYLPARABEN (UNII: 3QPI1U3FV8) SODIUM HYDROXIDE (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57913-2525-9 1 in 1 CARTON 1 100 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 04/10/2013 Labeler - Erno Laszlo, Inc. (098821031) Establishment Name Address ID/FEI Business Operations Mana Products 078870292 MANUFACTURE(57913-2525) , LABEL(57913-2525) , PACK(57913-2525)
