RICH ALMOND PERFECTING MAKEUP BROAD SPECTRUM SPF 25 MERLE NORMAN- octinoxate,titanium dioxide emulsion 
Merle Norman Cosmetics, Inc

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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Merle Norman Rich Almond Perfecting Makeup SPF 25

Active Ingredients purpose
Octinoxate 7.5% Sunscreen
Titanium Dioxide 7.1% 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 and persists.

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
· Apply liberally 15 minutes before sun exposure
· Reapply at least every 2 hours
· Use a water resistant sunscreen if swimming or sweating
· 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 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

Inactive Ingredients
Water (Aqua), Cyclopentasiloxane, Clyclohexasiloxane, Isododecane, Alcohol Denat.,
Cetyl PEG/PPG-10/1 Dimethicone, C12-15 Alkyl Benzoate, Acrylates/Dimethicone Copolymer,
Silica, Acrylates Copolymer, Sodium Myristoyl Glutamate, Sorbitan Sesquioleate,
Polyhydroxystearic Acid, Disteardimonium Hectorite, Caprylyl Glycol, Aluminum Oxide,
Stearic Acid, Propylene Glycol, Propylene Carbonate, Tetrasodium EDTA, Methylisothiazolinone,
May Contain: Iron Oxides, Titanium Dioxide, Triethoxycaprylylsilane

image of carton artimage of bottle art


Perfecting Makeup Broad Spectrum SPF 25
Merle Norman Established in Los Angeles since 1931
30 mL 1 Fl. Oz.

RICH ALMOND PERFECTING MAKEUP BROAD SPECTRUM SPF 25  MERLE NORMAN
octinoxate,titanium dioxide emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57627-134
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.25 g  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.13 g  in 30 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
ISODODECANE (UNII: A8289P68Y2)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM MYRISTOYL GLUTAMATE (UNII: AYU7QD893W)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57627-134-021 in 1 CARTON08/22/201209/14/2021
1NDC:57627-134-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/22/201209/14/2021
Labeler - Merle Norman Cosmetics, Inc (008479388)
Registrant - Merle Norman Cosmetics, Inc (008479388)
Establishment
NameAddressID/FEIBusiness Operations
Merle Norman Cosmetics, Inc 008479388manufacture(57627-134)

Revised: 11/2021
Document Id: d10562ed-39e8-b308-e053-2a95a90ae6cd
Set id: 1daac198-0818-4031-90c8-e035eb5009cc
Version: 13
Effective Time: 20211117
 
Merle Norman Cosmetics, Inc