![LUMIPEARL PERFECT AND PROTECT DAY BROAD SPECTRUM SPF 25 SUNSCREEN (HOMOSALATE, OCTISALATE, OXYBENZONE, AVOBENZONE, AND OCTOCRYLENE) CREAM [GUTHY-RENKER LLC]](https://medic.hrt.org//dailymed/images/8690ba7c-1073-47cb-bb16-d34453b0a624/lumipearl-01.jpg)
| NDC | 70605-041-57, 70605-041-65 |
| Set ID | 8690ba7c-1073-47cb-bb16-d34453b0a624 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Guthy-Renker LLC |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
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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 to face and neck 15 minutes prior to sun exposure.
- use a water resistant sunscreen if swimming or sweating
- reapply at least every 2 hours
- children under 6 months: Ask a doctor.
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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
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Inactive ingredients
Water, C12-15 Alkyl Benzoate, Cyclopentasiloxane, Propanediol, Silica, Sea Water (Maris Aqua), Cetearyl Alcohol, Dimethicone, Potassium Cetyl Phosphate, Phormidium Persicinum Extract, Sodium PCA, Tribehenin PEG-20 Esters, Sodium Hyaluronate, Nacre Protein, Glycerin, Nacre Lipids, Glyceryl Stearate, PEG-100 Stearate, Calcium Carbonate, Polysilicone-15, Disodium EDTA, Carbomer, Aminomethyl Propanol, Phenoxyethanol, Caprylyl Glycol, Chlorphenesin, Fragrance.
- Other information
- Questions or Comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Label
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INGREDIENTS AND APPEARANCE
LUMIPEARL PERFECT AND PROTECT DAY BROAD SPECTRUM SPF 25 SUNSCREEN
homosalate, octisalate, oxybenzone, avobenzone, and octocrylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70605-041 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate 8 mg in 100 mL Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 5 mg in 100 mL Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 3 mg in 100 mL Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 3 mg in 100 mL Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 2.7 mg in 100 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) PROPANEDIOL (UNII: 5965N8W85T) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) DIMETHICONE (UNII: 92RU3N3Y1O) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) PSEUDANABAENA PERSICINA (UNII: ZA983U4810) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) TRIBEHENIN PEG-20 ESTERS (UNII: 84K9EH29Y9) HYALURONATE SODIUM (UNII: YSE9PPT4TH) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) CALCIUM CARBONATE (UNII: H0G9379FGK) POLYSILICONE-15 (UNII: F8DRP5BB29) EDETATE DISODIUM (UNII: 7FLD91C86K) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70605-041-65 15 mL in 1 TUBE; Type 0: Not a Combination Product 05/31/2016 2 NDC:70605-041-57 50 mL in 1 TUBE; Type 0: Not a Combination Product 05/31/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 05/31/2016 Labeler - Guthy-Renker LLC (948861877)
