BARE EXPERT FINISH MAKEUP BROAD SPECTRUM SPF 25  MERLE NORMAN- octinoxate, titanium dioxide cream 
IVORY EXPERT FINISH MAKEUP BROAD SPECTRUM SPF 25  MERLE NORMAN- octinoxate, titanium dioxide cream 
PORCELAIN EXPERT FINISH MAKEUP BROAD SPECTRUM SPF 25  MERLE NORMAN- octinoxate, titanium dioxide cream 
ALABASTER BEIGE EXPERT FINISH MAKEUP BROAD SPECTRUM SPF 25  MERLE NORMAN- octinoxate, titanium dioxide cream 
CREAMY BEIGE EXPERT FINISH MAKEUP BROAD SPECTRUM SPF 25  MERLE NORMAN- octinoxate, titanium dioxide cream 
SIMPLY BEIGE EXPERT FINISH MAKEUP BROAD SPECTRUM SPF 25  MERLE NORMAN- octinoxate, titanium dioxide cream 
SOFT BISQUE EXPERT FINISH MAKEUP BROAD SPECTRUM SPF 25  MERLE NORMAN- octinoxate, titanium dioxide cream 
SAND EXPERT FINISH MAKEUP BROAD SPECTRUM SPF 25  MERLE NORMAN- octinoxate, titanium dioxide cream 
MEDIUM EXPERT FINISH MAKEUP BROAD SPECTRUM SPF 25  MERLE NORMAN- octinoxate, titanium dioxide cream 
SANDY BEIGE EXPERT FINISH MAKEUP BROAD SPECTRUM SPF 25  MERLE NORMAN- octinoxate, titanium dioxide cream 
DELICATE BEIGE EXPERT FINISH MAKEUP BROAD SPECTRUM SPF 25  MERLE NORMAN- octinoxate, titanium dioxide cream 
TAN EXPERT FINISH MAKEUP BROAD SPECTRUM SPF 25 MERLE NORMAN- octinoxate, titanium dioxide cream 
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.

----------

Expert Finish Makeup SPF 25

Active Ingredients                 Purpose

Octinoxate 4.0%                   Sunscreen

Titanium Dioxide 5.2%          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 sleeve shirts, pants, hats, and sunglasses

children under 6 months: Ask a doctor

Inactive Ingredients

Isononyl Isononanoate, Ethylhexyl Palmitate, Polyethylene, Nylon-12, C12-15 Alkyl Benzoate, Lauroyl Lysine, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Talc, Isostearyl Neopentanoate, Astrocaryum Murumuru Seed Butter, Cetyl Dimethicone, Silica, Aluminum Starch Octenylsuccinate, Copernicia Cerifera (Carnauba) Wax, Dimethicone, Tocopheryl Acetate, Polyhydroxystearic Acid, Stearic Acid, Polyurethane-40, Sorbitan Oleate, Sorbitan Laurate, Myristyl Malate Phosphonic Acid, BHT Aluminum Oxide, May Contain, Iron Oxides, Titanium Dioxide

Expert Finish Makeup Broad Spectrum SPF 25

Merle Norman

17 g Net Wt. .60 Oz

carton

Alabaster beige

Delicate Beige

Bare

Soft Bisque

creamy Beige

Sand

Medium

Sandy Beige

Ivory

Porcelain

Simply Beige

BARE EXPERT FINISH MAKEUP BROAD SPECTRUM SPF 25   MERLE NORMAN
octinoxate, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57627-157
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE4 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5.2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
NYLON-12 (UNII: 446U8J075B)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
LAUROYL LYSINE (UNII: 113171Q70B)  
TALC (UNII: 7SEV7J4R1U)  
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)  
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)  
PHOSPHONIC ACID (UNII: 35V6A8JW8E)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57627-157-021 in 1 CARTON10/20/2013
1NDC:57627-157-0117 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35210/20/2013
IVORY EXPERT FINISH MAKEUP BROAD SPECTRUM SPF 25   MERLE NORMAN
octinoxate, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57627-169
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE4 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5.2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
NYLON-12 (UNII: 446U8J075B)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
LAUROYL LYSINE (UNII: 113171Q70B)  
TALC (UNII: 7SEV7J4R1U)  
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)  
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)  
PHOSPHONIC ACID (UNII: 35V6A8JW8E)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57627-169-021 in 1 CARTON10/20/2013
1NDC:57627-169-0117 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35210/20/2013
PORCELAIN EXPERT FINISH MAKEUP BROAD SPECTRUM SPF 25   MERLE NORMAN
octinoxate, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57627-159
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE4 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5.2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
NYLON-12 (UNII: 446U8J075B)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
LAUROYL LYSINE (UNII: 113171Q70B)  
TALC (UNII: 7SEV7J4R1U)  
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)  
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)  
PHOSPHONIC ACID (UNII: 35V6A8JW8E)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57627-159-021 in 1 CARTON10/20/2013
1NDC:57627-159-0117 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35210/20/2013
ALABASTER BEIGE EXPERT FINISH MAKEUP BROAD SPECTRUM SPF 25   MERLE NORMAN
octinoxate, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57627-160
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE4 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5.2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
NYLON-12 (UNII: 446U8J075B)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
LAUROYL LYSINE (UNII: 113171Q70B)  
TALC (UNII: 7SEV7J4R1U)  
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)  
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)  
PHOSPHONIC ACID (UNII: 35V6A8JW8E)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57627-160-021 in 1 CARTON10/20/2013
1NDC:57627-160-0117 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35210/20/2013
CREAMY BEIGE EXPERT FINISH MAKEUP BROAD SPECTRUM SPF 25   MERLE NORMAN
octinoxate, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57627-161
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE4 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5.2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
NYLON-12 (UNII: 446U8J075B)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
LAUROYL LYSINE (UNII: 113171Q70B)  
TALC (UNII: 7SEV7J4R1U)  
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)  
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)  
PHOSPHONIC ACID (UNII: 35V6A8JW8E)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57627-161-021 in 1 CARTON10/20/2013
1NDC:57627-161-0117 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35210/20/2013
SIMPLY BEIGE EXPERT FINISH MAKEUP BROAD SPECTRUM SPF 25   MERLE NORMAN
octinoxate, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57627-162
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE4 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5.2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
NYLON-12 (UNII: 446U8J075B)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
LAUROYL LYSINE (UNII: 113171Q70B)  
TALC (UNII: 7SEV7J4R1U)  
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)  
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)  
PHOSPHONIC ACID (UNII: 35V6A8JW8E)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57627-162-021 in 1 CARTON10/20/2013
1NDC:57627-162-0117 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35210/20/2013
SOFT BISQUE EXPERT FINISH MAKEUP BROAD SPECTRUM SPF 25   MERLE NORMAN
octinoxate, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57627-163
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE4 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5.2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
NYLON-12 (UNII: 446U8J075B)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
LAUROYL LYSINE (UNII: 113171Q70B)  
TALC (UNII: 7SEV7J4R1U)  
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)  
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)  
PHOSPHONIC ACID (UNII: 35V6A8JW8E)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57627-163-021 in 1 CARTON10/20/2013
1NDC:57627-163-0117 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35210/20/2013
SAND EXPERT FINISH MAKEUP BROAD SPECTRUM SPF 25   MERLE NORMAN
octinoxate, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57627-164
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE4 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5.2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
NYLON-12 (UNII: 446U8J075B)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
LAUROYL LYSINE (UNII: 113171Q70B)  
TALC (UNII: 7SEV7J4R1U)  
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)  
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)  
PHOSPHONIC ACID (UNII: 35V6A8JW8E)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57627-164-021 in 1 CARTON10/20/2013
1NDC:57627-164-0117 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35210/20/2013
MEDIUM EXPERT FINISH MAKEUP BROAD SPECTRUM SPF 25   MERLE NORMAN
octinoxate, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57627-165
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE4 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5.2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
NYLON-12 (UNII: 446U8J075B)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
LAUROYL LYSINE (UNII: 113171Q70B)  
TALC (UNII: 7SEV7J4R1U)  
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)  
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)  
PHOSPHONIC ACID (UNII: 35V6A8JW8E)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57627-165-021 in 1 CARTON10/20/2013
1NDC:57627-165-0117 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35210/20/2013
SANDY BEIGE EXPERT FINISH MAKEUP BROAD SPECTRUM SPF 25   MERLE NORMAN
octinoxate, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57627-166
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE4 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5.2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
NYLON-12 (UNII: 446U8J075B)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
LAUROYL LYSINE (UNII: 113171Q70B)  
TALC (UNII: 7SEV7J4R1U)  
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)  
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)  
PHOSPHONIC ACID (UNII: 35V6A8JW8E)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57627-166-021 in 1 CARTON10/20/2013
1NDC:57627-166-0117 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35210/20/2013
DELICATE BEIGE EXPERT FINISH MAKEUP BROAD SPECTRUM SPF 25   MERLE NORMAN
octinoxate, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57627-167
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE4 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5.2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
NYLON-12 (UNII: 446U8J075B)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
LAUROYL LYSINE (UNII: 113171Q70B)  
TALC (UNII: 7SEV7J4R1U)  
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)  
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)  
PHOSPHONIC ACID (UNII: 35V6A8JW8E)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57627-167-021 in 1 CARTON10/20/2013
1NDC:57627-167-0117 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35210/20/2013
TAN EXPERT FINISH MAKEUP BROAD SPECTRUM SPF 25  MERLE NORMAN
octinoxate, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57627-168
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE4 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5.2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
NYLON-12 (UNII: 446U8J075B)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
LAUROYL LYSINE (UNII: 113171Q70B)  
TALC (UNII: 7SEV7J4R1U)  
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)  
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)  
PHOSPHONIC ACID (UNII: 35V6A8JW8E)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57627-168-021 in 1 CARTON10/20/201305/24/2021
1NDC:57627-168-0117 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35210/20/201305/24/2021
Labeler - Merle Norman Cosmetics, Inc (008479388)
Registrant - Merle Norman Cosmetics, Inc (008479388)
Establishment
NameAddressID/FEIBusiness Operations
Merle Norman Cosmetics, Inc 008479388manufacture(57627-157, 57627-169, 57627-159, 57627-160, 57627-161, 57627-162, 57627-163, 57627-164, 57627-165, 57627-166, 57627-167, 57627-168)

Revised: 5/2021
Document Id: c2c76313-5960-6975-e053-2a95a90a21d1
Set id: ff396aca-cf64-45f8-ba2e-c4fc55d6484b
Version: 13
Effective Time: 20210520
 
Merle Norman Cosmetics, Inc