![ULTRA LIGHT SUNSCREEN BROAD SPECTRUM SPF 50 MERLE NORMAN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [MERLE NORMAN COSMETICS]](https://medic.hrt.org//dailymed/images/42c43f36-982e-429c-8f2a-2bced1d3b172/carton.jpg)
![ULTRA LIGHT SUNSCREEN BROAD SPECTRUM SPF 50 MERLE NORMAN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [MERLE NORMAN COSMETICS]](https://medic.hrt.org//dailymed/images/42c43f36-982e-429c-8f2a-2bced1d3b172/tube.jpg)
| NDC | 57627-117-01, 57627-117-02, 57627-117-03, 57627-117-04 |
| Set ID | 42c43f36-982e-429c-8f2a-2bced1d3b172 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Merle Norman Cosmetics |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
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ACTIVE INGREDIENT
Active ingredients Purpose
Avobenzone 3.0% Sunscreen
Homosalate 10.0% Sunscreen
Octisalate 5.0% Sunscreen
Octocrylene 2.75% Sunscreen
Oxybenzone 6.0% Sunscreen
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 sunKeep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Stop use and ask a doctor if rash occurs
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.
Directions
• For sunscreen use:
• apply liberally and evenly 15 minutes before sun exposure
• use a water resistant sunscreen if swimming or sweating
• reapply 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 value 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-sleeved shirts, pants, hats, and sunglasses
• children under 6 months: Ask a doctor
Inactive ingredients:
Water, Cyclopentasiloxane, Butyloctyl Salicylate, Pentylene Glycol, Glycerin, Silica, Potassium Cetyl Phosphate, Dimethicone, Hydrogenated Palm Glycerides, Bis-ethylhexyl Hydroxydimethoxy Benzylmalonate, Polyisobutene, Propylene Glycol, Glyceryl Stearate, PEG-100 Stearate, Methyl Methacrylate Crosspolymer, Sodium Acrylate/ Sodium Acryloyldimethyl Taurate Copolymer, Acrylates/Dimethicone Copolymer, Trimethylsiloxysilicate, Caprylyl/Capryl Glucoside, Xanthan Gum, Disodium EDTA, BHT, Methylisothiazolinone, Caprylyl Glycol, Fragrance
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INGREDIENTS AND APPEARANCE
ULTRA LIGHT SUNSCREEN BROAD SPECTRUM SPF 50 MERLE NORMAN
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57627-117 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3.39 g in 113 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 11.3 g in 113 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5.65 g in 113 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 3.11 g in 113 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 6.78 g in 113 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) PENTYLENE GLYCOL (UNII: 50C1307PZG) GLYCERIN (UNII: PDC6A3C0OX) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) DIMETHICONE (UNII: 92RU3N3Y1O) BIS-ETHYLHEXYL HYDROXYDIMETHOXY BENZYLMALONATE (UNII: 7D4Q5YJ8NV) POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX) CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0) XANTHAN GUM (UNII: TTV12P4NEE) EDETATE DISODIUM (UNII: 7FLD91C86K) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) CAPRYLYL GLYCOL (UNII: 00YIU5438U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57627-117-02 1 in 1 CARTON 03/29/2013 1 NDC:57627-117-01 113 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:57627-117-04 1 in 1 CARTON 11/30/2016 2 NDC:57627-117-03 28 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 03/29/2013 Labeler - Merle Norman Cosmetics (008479388) Registrant - Merle Norman Cosmetics (008479388) Establishment Name Address ID/FEI Business Operations Merle Norman Cosmetics 008479388 manufacture(57627-117)
