ULTRA LIGHT SUNSCREEN BROAD SPECTRUM SPF 50 MERLE NORMAN- avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion 
Merle Norman Cosmetics

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Ultra Light Sunscreen Broad Spectrum SPF 50

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 sun

Keep 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

carton

tube

ULTRA LIGHT SUNSCREEN

BROAD SPECTRUM SPF 50

Merle Norman

Established in Los Angeles since 1931

113 g NET WT. 4 OZ.

ULTRA LIGHT SUNSCREEN BROAD SPECTRUM SPF 50  MERLE NORMAN
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57627-117
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3.39 g  in 113 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE11.3 g  in 113 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5.65 g  in 113 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE3.11 g  in 113 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE6.78 g  in 113 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57627-117-021 in 1 CARTON03/29/2013
1NDC:57627-117-01113 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:57627-117-041 in 1 CARTON11/30/2016
2NDC:57627-117-0328 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35203/29/2013
Labeler - Merle Norman Cosmetics (008479388)
Registrant - Merle Norman Cosmetics (008479388)
Establishment
NameAddressID/FEIBusiness Operations
Merle Norman Cosmetics008479388manufacture(57627-117)

Revised: 1/2020
Document Id: 7e5b2480-dc33-4f2a-9163-b4002874bf98
Set id: 42c43f36-982e-429c-8f2a-2bced1d3b172
Version: 9
Effective Time: 20200127
 
Merle Norman Cosmetics