Label: 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
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NDC Code(s):
57627-157-01,
57627-157-02,
57627-159-01,
57627-159-02, view more57627-160-01, 57627-160-02, 57627-161-01, 57627-161-02, 57627-162-01, 57627-162-02, 57627-163-01, 57627-163-02, 57627-164-01, 57627-164-02, 57627-165-01, 57627-165-02, 57627-166-01, 57627-166-02, 57627-167-01, 57627-167-02, 57627-168-01, 57627-168-02, 57627-169-01, 57627-169-02
- Packager: Merle Norman Cosmetics, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated May 20, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
-
DOSAGE & ADMINISTRATION
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
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INACTIVE INGREDIENT
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
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
BARE EXPERT FINISH MAKEUP BROAD SPECTRUM SPF 25 Â MERLE NORMAN
octinoxate, titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57627-157 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 4 g  in 100 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 5.2 g  in 100 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:57627-157-02 1 in 1 CARTON 10/20/2013 1 NDC:57627-157-01 17 g in 1 BOTTLE; 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 10/20/2013 IVORY EXPERT FINISH MAKEUP BROAD SPECTRUM SPF 25  MERLE NORMAN
octinoxate, titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57627-169 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 4 g  in 100 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 5.2 g  in 100 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:57627-169-02 1 in 1 CARTON 10/20/2013 1 NDC:57627-169-01 17 g in 1 BOTTLE; 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 10/20/2013 PORCELAIN EXPERT FINISH MAKEUP BROAD SPECTRUM SPF 25  MERLE NORMAN
octinoxate, titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57627-159 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 4 g  in 100 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 5.2 g  in 100 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:57627-159-02 1 in 1 CARTON 10/20/2013 1 NDC:57627-159-01 17 g in 1 BOTTLE; 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 10/20/2013 ALABASTER BEIGE EXPERT FINISH MAKEUP BROAD SPECTRUM SPF 25  MERLE NORMAN
octinoxate, titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57627-160 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 4 g  in 100 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 5.2 g  in 100 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:57627-160-02 1 in 1 CARTON 10/20/2013 1 NDC:57627-160-01 17 g in 1 BOTTLE; 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 10/20/2013 CREAMY BEIGE EXPERT FINISH MAKEUP BROAD SPECTRUM SPF 25  MERLE NORMAN
octinoxate, titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57627-161 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 4 g  in 100 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 5.2 g  in 100 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:57627-161-02 1 in 1 CARTON 10/20/2013 1 NDC:57627-161-01 17 g in 1 BOTTLE; 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 10/20/2013 SIMPLY BEIGE EXPERT FINISH MAKEUP BROAD SPECTRUM SPF 25  MERLE NORMAN
octinoxate, titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57627-162 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 4 g  in 100 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 5.2 g  in 100 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:57627-162-02 1 in 1 CARTON 10/20/2013 1 NDC:57627-162-01 17 g in 1 BOTTLE; 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 10/20/2013 SOFT BISQUE EXPERT FINISH MAKEUP BROAD SPECTRUM SPF 25  MERLE NORMAN
octinoxate, titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57627-163 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 4 g  in 100 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 5.2 g  in 100 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:57627-163-02 1 in 1 CARTON 10/20/2013 1 NDC:57627-163-01 17 g in 1 BOTTLE; 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 10/20/2013 SAND EXPERT FINISH MAKEUP BROAD SPECTRUM SPF 25  MERLE NORMAN
octinoxate, titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57627-164 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 4 g  in 100 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 5.2 g  in 100 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:57627-164-02 1 in 1 CARTON 10/20/2013 1 NDC:57627-164-01 17 g in 1 BOTTLE; 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 10/20/2013 MEDIUM EXPERT FINISH MAKEUP BROAD SPECTRUM SPF 25  MERLE NORMAN
octinoxate, titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57627-165 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 4 g  in 100 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 5.2 g  in 100 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:57627-165-02 1 in 1 CARTON 10/20/2013 1 NDC:57627-165-01 17 g in 1 BOTTLE; 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 10/20/2013 SANDY BEIGE EXPERT FINISH MAKEUP BROAD SPECTRUM SPF 25  MERLE NORMAN
octinoxate, titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57627-166 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 4 g  in 100 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 5.2 g  in 100 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:57627-166-02 1 in 1 CARTON 10/20/2013 1 NDC:57627-166-01 17 g in 1 BOTTLE; 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 10/20/2013 DELICATE BEIGE EXPERT FINISH MAKEUP BROAD SPECTRUM SPF 25  MERLE NORMAN
octinoxate, titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57627-167 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 4 g  in 100 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 5.2 g  in 100 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:57627-167-02 1 in 1 CARTON 10/20/2013 1 NDC:57627-167-01 17 g in 1 BOTTLE; 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 10/20/2013 TAN EXPERT FINISH MAKEUP BROAD SPECTRUM SPF 25 MERLE NORMAN
octinoxate, titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57627-168 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 4 g  in 100 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 5.2 g  in 100 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:57627-168-02 1 in 1 CARTON 10/20/2013 05/24/2021 1 NDC:57627-168-01 17 g in 1 BOTTLE; 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 10/20/2013 05/24/2021 Labeler - Merle Norman Cosmetics, Inc (008479388) Registrant - Merle Norman Cosmetics, Inc (008479388) Establishment Name Address ID/FEI Business Operations Merle Norman Cosmetics, Inc 008479388 manufacture(57627-157, 57627-169, 57627-159, 57627-160, 57627-161, 57627-162, 57627-163, 57627-164, 57627-165, 57627-166, 57627-167, 57627-168)