DailyMed - TOTY ILUMINA CC CREAM 1N- titanium dioxide, zinc oxide cream TOTY ILUMINA CC CREAM 4C- titanium dioxide, zinc oxide cream TOTY ILUMINA CC CREAM 1C- titanium dioxide, zinc oxide cream TOTY ILUMINA CC CREAM 1W- titanium dioxide, zinc oxide cream TOTY ILUMINA CC CREAM 2N- titanium dioxide, zinc oxide cream TOTY ILUMINA CC CREAM 3C- titanium dioxide, zinc oxide cream TOTY ILUMINA CC CREAM 5W1- titanium dioxide, zinc oxide cream TOTY ILUMINA CC CREAM 5W2- titanium dioxide, zinc oxide cream TOTY ILUMINA CC CREAM 3W- titanium dioxide, zinc oxide cream TOTY ILUMINA CC CREAM 4N- titanium dioxide, zinc oxide cream TOTY ILUMINA CC CREAM 5W- titanium dioxide, zinc oxide cream TOTY ILUMINA CC CREAM 3N- titanium dioxide, zinc oxide cream TOTY ILUMINA CC CREAM 4W- titanium dioxide, zinc oxide cream TOTY ILUMINA CC CREAM 2C- titanium dioxide, zinc oxide cream TOTY ILUMINA CC CREAM 2W- titanium dioxide, zinc oxide cream

NDC Code(s): 82141-2327-1, 82141-2328-1, 82141-2329-1, 82141-2330-1, view more
82141-2331-1, 82141-2332-1, 82141-2333-1, 82141-2334-1, 82141-2335-1, 82141-2336-1, 82141-2337-1, 82141-2338-1, 82141-2339-1, 82141-2340-1, 82141-2341-1
Packager: Chipican LLC

Category: HUMAN OTC DRUG LABEL

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 September 27, 2022

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

Download DRUG LABEL INFO: PDF XML
Official Label (Printer Friendly)

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Active Ingredients

Titanium Dioxide 9%

Zinc Oxide 6.3%
Purpose

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.
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.

Stop use and ask a doctor if Rash occurs
KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION
- Apply liberally 15 minutes behore sun exposure
- Reapply at least every 2 hours
- Use a water-resistant sunscreen if swimmimg 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 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 of age: Ask a doctor.
Other Information
- Shake well before use
- Do not expose the product to high temperatures
- Protect the product in this container from excessive heat and direct sun
Inactive Ingredients

NDCs 82141-2327-1, 82141-2328-1

Water, Butylene Glycol Cocoate,Hexylene Glycol, C12-15

Alkyl Benzoate, Cetearyl Alcohol, Butyloctyl Salicylate,

Styrene/Acrylates Copolymer, Dicaprylyl Carbonate, Coco

Glucoside, Myristyl Alcohol, Ceteareth-25, Propylene Glycol,

Dipropylene Glycol Dibenzoate, Phenoxyethanol, Silica,

Disodium Ethylene Dicocamide PEG-15 Disulfate,

Phenylpropanol, Myristyl Glucoside, Panthenol, Calaguala

( Polypodium leucotomos) Leaf Extract, Sodium Hyaluronate,

Caprylyl Glycol, Tea ( Camellia sinensis) Leaf Extract,

Propanediol, PPG-15 Stearyl Ether Benzoate,

Stearalkonium Hectorite, Propylene Carbonate, Tocopheryl

Acetate, BHT, Citric Acid, Disodium EDTA, Fragrance,

Linalool, Synthetic Iron Oxide* (CI 77491, CI 77492, CI

77499), Titanium Dioxide* (CI 77891), Bismuth Oxychloride*

(CI 77163).

* Contains one or more of these ingredients.

NDCs 82141-2329-1, 82141-2330-1, 82141-2331-1, 82141-2332-1, 82141-2333-1

82141-2334-1, 82141-2336-1 & 82141-2338-1

Water, Butylene Glycol Cocoate,Hexylene Glycol, C12-15

Alkyl Benzoate, Cetearyl Alcohol, Butyloctyl Salicylate,

Styrene/Acrylates Copolymer, Dicaprylyl Carbonate, Coco

Glucoside, Myristyl Alcohol, Ceteareth-25, Propylene Glycol,

Dipropylene Glycol Dibenzoate, Phenoxyethanol, Silica,

Disodium Ethylene Dicocamide PEG-15 Disulfate,

Phenylpropanol, Myristyl Glucoside, Panthenol, Calaguala

( Polypodium leucotomos) Leaf Extract, Sodium Hyaluronate,

Caprylyl Glycol, Mica, Tea ( Camellia sinensis) Leaf Extract,

Propanediol, PPG-15 Stearyl Ether Benzoate,

Stearalkonium Hectorite, Propylene Carbonate, Tocopheryl

Acetate, BHT, Citric Acid, Disodium EDTA, Fragrance,

Linalool, Synthetic Iron Oxide* (CI 77491, CI 77492, CI

77499), Titanium Dioxide* (CI 77891), Bismuth Oxychloride*

(CI 77163).

* Contains one or more of these ingredients.

NDCs 82141-2335-1

Water, Butylene Glycol Cocoate,Hexylene Glycol, C12-15

Alkyl Benzoate, Cetearyl Alcohol, Butyloctyl Salicylate,

Styrene/Acrylates Copolymer, Dicaprylyl Carbonate, Coco

Glucoside, Myristyl Alcohol, Ceteareth-25, Propylene Glycol,

Dipropylene Glycol Dibenzoate, Phenoxyethanol, Silica,

Disodium Ethylene Dicocamide PEG-15 Disulfate,

Phenylpropanol, Myristyl Glucoside, Panthenol, Calaguala

( Polypodium leucotomos) Leaf Extract, Sodium Hyaluronate,

Caprylyl Glycol, Mica, Tea ( Camellia sinensis) Leaf Extract,

Propanediol, PPG-15 Stearyl Ether Benzoate,

Stearalkonium Hectorite, Propylene Carbonate, Tocopheryl

Acetate, BHT, Citric Acid, Disodium EDTA,

Triethoxycaprylylsilane, Fragrance, Linalool, Synthetic Iron

Oxide* (CI 77491, CI 77492, CI 77499), Titanium Dioxide*

(CI 77891), Bismuth Oxychloride* (CI 77163).

* Contains one or more of these ingredients.

NDCs 82141-2337-1 &82141-2339-1

Water, Butylene Glycol Cocoate,Hexylene Glycol, C12-15

Alkyl Benzoate, Butyloctyl Salicylate, Styrene/Acrylates

Copolymer, Ceteareth-25, Glyceril Stearate, PEG-100

Stearate, Propylene Glycol, Dipropylene Glycol Dibenzoate,

Silica, Phenoxyethanol, Disodium Ethylene Dicocamide

PEG-15 Disulfate, Phenylpropanol, Panthenol, Calaguala

( Polypodium leucotomos) Leaf Extract, Sodium Hyaluronate,

Caprylyl Glycol, Mica, Tea ( Camellia sinensis) Leaf Extract,

Propanediol, PPG-15 Stearyl Ether Benzoate, Tocopheryl

Acetate, Steareth-21, Steareth-2, Triethoxycaprylylsilane,

BHT, Citric Acid, Disodium EDTA, Fragrance, Linalool,

Synthetic Iron Oxide* (CI 77491, CI 77492, CI 77499).

* Contains one or more of these ingredients.

NDCs 82141-2340-1 & 82141-2341-1

Water, Butylene Glycol Cocoate,Hexylene Glycol, C12-15

Alkyl Benzoate, Butyloctyl Salicylate, Styrene/Acrylates

Copolymer, Ceteareth-25, Propylene Glycol, Dipropylene

Glycol Dibenzoate, Silica, Phenoxyethanol, Phenylpropanol,

Disodium Ethylene Dicocamide PEG-15 Disulfate,

Panthenol, Calaguala ( Polypodium leucotomos) Leaf

Extract, Sodium Hyaluronate, Caprylyl Glycol, Mica, Tea

( Camellia sinensis) Leaf Extract, Propanediol, PPG-15

Stearyl Ether Benzoate, Tocopheryl Acetate, Glyceryl

Stearate, PEG-100 Stearate, Steareth-21, Steareth-2,

Triethoxycaprylylsilane, BHT, Citric Acid, Disodium EDTA,

Fragrance, Linalool, Synthetic Iron Oxide* (CI 77491, CI

77492, CI 77499).

* Contains one or more of these ingredients.
toty Ilumina CC Cream 1N

NDC 82141-2327-1 (toty Ilumina CC Cream 1N)

toty.

ILUMINA

CC CREAM

SPF 50+

Perfecting Fluid

Fluido

Perfeccionador

.......................................................

BROAD SPECTRUM SPF 50+

MINERAL SUNSCREEN

PROTECTOR SOLAR MINERAL

AMPLIO ESPECTRO SPF 50+

1.4 fl. oz./ 40 ml
toty Ilumina CC Cream 1W

NDC 82141-2328-1 (toty Ilumina CC Cream 1W)

toty.

ILUMINA

CC CREAM

SPF 50+

Perfecting Fluid

Fluido

Perfeccionador

.......................................................

BROAD SPECTRUM SPF 50+

MINERAL SUNSCREEN

PROTECTOR SOLAR MINERAL

AMPLIO ESPECTRO SPF 50+

1.4 fl. oz./ 40 ml
toty Ilumina CC Cream 1C

NDC 82141-2329-1 (toty Ilumina CC Cream 1C)

toty.

ILUMINA

CC CREAM

SPF 50+

Perfecting Fluid

Fluido

Perfeccionador

.......................................................

BROAD SPECTRUM SPF 50+

MINERAL SUNSCREEN

PROTECTOR SOLAR MINERAL

AMPLIO ESPECTRO SPF 50+

1.4 fl. oz./ 40 ml
toty Ilumina CC Cream 2N

NDC 82141-2330-1 (toty Ilumina CC Cream 2N)

toty.

ILUMINA

CC CREAM

SPF 50+

Perfecting Fluid

Fluido

Perfeccionador

.......................................................

BROAD SPECTRUM SPF 50+

MINERAL SUNSCREEN

PROTECTOR SOLAR MINERAL

AMPLIO ESPECTRO SPF 50+

1.4 fl. oz./ 40 ml
toty Ilumina CC Cream 2W

NDC 82141-2331-1 (toty Ilumina CC Cream 2W)

toty.

ILUMINA

CC CREAM

SPF 50+

Perfecting Fluid

Fluido

Perfeccionador

.......................................................

BROAD SPECTRUM SPF 50+

MINERAL SUNSCREEN

PROTECTOR SOLAR MINERAL

AMPLIO ESPECTRO SPF 50+

1.4 fl. oz./ 40 ml
toty Ilumina CC Cream 2C

NDC 82141-2332-1 (toty Ilumina CC Cream 2C)

toty.

ILUMINA

CC CREAM

SPF 50+

Perfecting Fluid

Fluido

Perfeccionador

.......................................................

BROAD SPECTRUM SPF 50+

MINERAL SUNSCREEN

PROTECTOR SOLAR MINERAL

AMPLIO ESPECTRO SPF 50+

1.4 fl. oz./ 40 ml
toty Ilumina CC Cream 3N

NDC 82141-2333-1 (toty Ilumina CC Cream 3N)

toty.

ILUMINA

CC CREAM

SPF 50+

Perfecting Fluid

Fluido

Perfeccionador

.......................................................

BROAD SPECTRUM SPF 50+

MINERAL SUNSCREEN

PROTECTOR SOLAR MINERAL

AMPLIO ESPECTRO SPF 50+

1.4 fl. oz./ 40 ml
toty Ilumina CC Cream 3W

NDC 82141-2334-1 (toty Ilumina CC Cream 3W)

toty.

ILUMINA

CC CREAM

SPF 50+

Perfecting Fluid

Fluido

Perfeccionador

.......................................................

BROAD SPECTRUM SPF 50+

MINERAL SUNSCREEN

PROTECTOR SOLAR MINERAL

AMPLIO ESPECTRO SPF 50+

1.4 fl. oz./ 40 ml
toty Ilumina CC Cream 3C

NDC 82141-2335-1 (toty Ilumina CC Cream 3C)

toty.

ILUMINA

CC CREAM

SPF 50+

Perfecting Fluid

Fluido

Perfeccionador

.......................................................

BROAD SPECTRUM SPF 50+

MINERAL SUNSCREEN

PROTECTOR SOLAR MINERAL

AMPLIO ESPECTRO SPF 50+

1.4 fl. oz./ 40 ml
toty Ilumina CC Cream 4N

NDC 82141-2336-1 (toty Ilumina CC Cream 4N)

toty.

ILUMINA

CC CREAM

SPF 50+

Perfecting Fluid

Fluido

Perfeccionador

.......................................................

BROAD SPECTRUM SPF 50+

MINERAL SUNSCREEN

PROTECTOR SOLAR MINERAL

AMPLIO ESPECTRO SPF 50+

1.4 fl. oz./ 40 ml
toty Ilumina CC Cream 4W

NDC 82141-2337-1 (toty Ilumina CC Cream 4W)

toty.

ILUMINA

CC CREAM

SPF 50+

Perfecting Fluid

Fluido

Perfeccionador

.......................................................

BROAD SPECTRUM SPF 50+

MINERAL SUNSCREEN

PROTECTOR SOLAR MINERAL

AMPLIO ESPECTRO SPF 50+

1.4 fl. oz./ 40 ml
toty Ilumina CC Cream 4C

NDC 82141-2338-1 (toty Ilumina CC Cream 4C)

toty.

ILUMINA

CC CREAM

SPF 50+

Perfecting Fluid

Fluido

Perfeccionador

.......................................................

BROAD SPECTRUM SPF 50+

MINERAL SUNSCREEN

PROTECTOR SOLAR MINERAL

AMPLIO ESPECTRO SPF 50+

1.4 fl. oz./ 40 ml
toty Ilumina CC Cream 5W

NDC 82141-2339-1 (toty Ilumina CC Cream 5W)

toty.

ILUMINA

CC CREAM

SPF 50+

Perfecting Fluid

Fluido

Perfeccionador

.......................................................

BROAD SPECTRUM SPF 50+

MINERAL SUNSCREEN

PROTECTOR SOLAR MINERAL

AMPLIO ESPECTRO SPF 50+

1.4 fl. oz./ 40 ml
toty Ilumina CC Cream 5W1

NDC 82141-2340-1 (toty Ilumina CC Cream 5W1)

toty.

ILUMINA

CC CREAM

SPF 50+

Perfecting Fluid

Fluido

Perfeccionador

.......................................................

BROAD SPECTRUM SPF 50+

MINERAL SUNSCREEN

PROTECTOR SOLAR MINERAL

AMPLIO ESPECTRO SPF 50+

1.4 fl. oz./ 40 ml
toty Ilumina CC Cream 5W2

NDC 82141-2341-1 (toty Ilumina CC Cream 5W2)

toty.

ILUMINA

CC CREAM

SPF 50+

Perfecting Fluid

Fluido

Perfeccionador

.......................................................

BROAD SPECTRUM SPF 50+

MINERAL SUNSCREEN

PROTECTOR SOLAR MINERAL

AMPLIO ESPECTRO SPF 50+

1.4 fl. oz./ 40 ml

INGREDIENTS AND APPEARANCE

TOTY ILUMINA CC CREAM 1N
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82141-2327
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	9 g in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	6.3 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
1,3-BUTYLENE GLYCOL COCOATE (UNII: B2JUC5N9EH)
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER (UNII: V5RS026Q0H)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHLEBODIUM AUREUM LEAF (UNII: BG58BW230G)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
COCO GLUCOSIDE (UNII: ICS790225B)
WATER (UNII: 059QF0KO0R)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CETEARETH-25 (UNII: 8FA93U5T67)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
DIPROPYLENE GLYCOL DIBENZOATE (UNII: 6OA5ZDY41O)
PROPANEDIOL (UNII: 5965N8W85T)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DISODIUM ETHYLENE DICOCAMIDE PEG-15 DISULFATE (UNII: QI9A6U005W)
PPG-15 STEARYL ETHER BENZOATE (UNII: 80D2J6361M)
PHENYLPROPANOL (UNII: 0F897O3O4M)
MYRISTYL ALCOHOL (UNII: V42034O9PU)
MYRISTYL GLUCOSIDE (UNII: 6AK28695LF)
PANTHENOL (UNII: WV9CM0O67Z)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:82141-2327-1	1 in 1 CARTON	10/01/2022
1		40 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M020	10/01/2022

TOTY ILUMINA CC CREAM 4C
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82141-2338
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	9 g in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	6.3 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER (UNII: V5RS026Q0H)
1,3-BUTYLENE GLYCOL COCOATE (UNII: B2JUC5N9EH)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHLEBODIUM AUREUM LEAF (UNII: BG58BW230G)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
COCO GLUCOSIDE (UNII: ICS790225B)
WATER (UNII: 059QF0KO0R)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CETEARETH-25 (UNII: 8FA93U5T67)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
DIPROPYLENE GLYCOL DIBENZOATE (UNII: 6OA5ZDY41O)
PROPANEDIOL (UNII: 5965N8W85T)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DISODIUM ETHYLENE DICOCAMIDE PEG-15 DISULFATE (UNII: QI9A6U005W)
PPG-15 STEARYL ETHER BENZOATE (UNII: 80D2J6361M)
PHENYLPROPANOL (UNII: 0F897O3O4M)
MYRISTYL ALCOHOL (UNII: V42034O9PU)
MYRISTYL GLUCOSIDE (UNII: 6AK28695LF)
PANTHENOL (UNII: WV9CM0O67Z)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:82141-2338-1	1 in 1 CARTON	10/01/2022
1		40 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M020	10/01/2022

TOTY ILUMINA CC CREAM 1C
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82141-2329
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	9 g in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	6.3 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER (UNII: V5RS026Q0H)
1,3-BUTYLENE GLYCOL COCOATE (UNII: B2JUC5N9EH)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHLEBODIUM AUREUM LEAF (UNII: BG58BW230G)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
COCO GLUCOSIDE (UNII: ICS790225B)
WATER (UNII: 059QF0KO0R)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CETEARETH-25 (UNII: 8FA93U5T67)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
DIPROPYLENE GLYCOL DIBENZOATE (UNII: 6OA5ZDY41O)
PROPANEDIOL (UNII: 5965N8W85T)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DISODIUM ETHYLENE DICOCAMIDE PEG-15 DISULFATE (UNII: QI9A6U005W)
PPG-15 STEARYL ETHER BENZOATE (UNII: 80D2J6361M)
PHENYLPROPANOL (UNII: 0F897O3O4M)
MYRISTYL ALCOHOL (UNII: V42034O9PU)
MYRISTYL GLUCOSIDE (UNII: 6AK28695LF)
PANTHENOL (UNII: WV9CM0O67Z)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:82141-2329-1	1 in 1 CARTON	10/01/2022
1		40 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M020	10/01/2022

TOTY ILUMINA CC CREAM 1W
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82141-2328
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	9 g in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	6.3 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER (UNII: V5RS026Q0H)
1,3-BUTYLENE GLYCOL COCOATE (UNII: B2JUC5N9EH)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHLEBODIUM AUREUM LEAF (UNII: BG58BW230G)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
COCO GLUCOSIDE (UNII: ICS790225B)
WATER (UNII: 059QF0KO0R)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CETEARETH-25 (UNII: 8FA93U5T67)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
DIPROPYLENE GLYCOL DIBENZOATE (UNII: 6OA5ZDY41O)
PROPANEDIOL (UNII: 5965N8W85T)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DISODIUM ETHYLENE DICOCAMIDE PEG-15 DISULFATE (UNII: QI9A6U005W)
PPG-15 STEARYL ETHER BENZOATE (UNII: 80D2J6361M)
PHENYLPROPANOL (UNII: 0F897O3O4M)
MYRISTYL ALCOHOL (UNII: V42034O9PU)
MYRISTYL GLUCOSIDE (UNII: 6AK28695LF)
PANTHENOL (UNII: WV9CM0O67Z)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:82141-2328-1	1 in 1 CARTON	10/01/2022
1		40 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M020	10/01/2022

TOTY ILUMINA CC CREAM 2N
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82141-2330
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	9 g in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	6.3 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER (UNII: V5RS026Q0H)
1,3-BUTYLENE GLYCOL COCOATE (UNII: B2JUC5N9EH)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHLEBODIUM AUREUM LEAF (UNII: BG58BW230G)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
COCO GLUCOSIDE (UNII: ICS790225B)
WATER (UNII: 059QF0KO0R)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CETEARETH-25 (UNII: 8FA93U5T67)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
DIPROPYLENE GLYCOL DIBENZOATE (UNII: 6OA5ZDY41O)
PROPANEDIOL (UNII: 5965N8W85T)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DISODIUM ETHYLENE DICOCAMIDE PEG-15 DISULFATE (UNII: QI9A6U005W)
PPG-15 STEARYL ETHER BENZOATE (UNII: 80D2J6361M)
PHENYLPROPANOL (UNII: 0F897O3O4M)
MYRISTYL ALCOHOL (UNII: V42034O9PU)
MYRISTYL GLUCOSIDE (UNII: 6AK28695LF)
PANTHENOL (UNII: WV9CM0O67Z)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:82141-2330-1	1 in 1 CARTON	10/01/2022
1		40 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M020	10/01/2022

TOTY ILUMINA CC CREAM 3C
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82141-2335
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	9 g in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	6.3 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
1,3-BUTYLENE GLYCOL COCOATE (UNII: B2JUC5N9EH)
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER (UNII: V5RS026Q0H)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHLEBODIUM AUREUM LEAF (UNII: BG58BW230G)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
COCO GLUCOSIDE (UNII: ICS790225B)
WATER (UNII: 059QF0KO0R)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CETEARETH-25 (UNII: 8FA93U5T67)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
DIPROPYLENE GLYCOL DIBENZOATE (UNII: 6OA5ZDY41O)
PROPANEDIOL (UNII: 5965N8W85T)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DISODIUM ETHYLENE DICOCAMIDE PEG-15 DISULFATE (UNII: QI9A6U005W)
PPG-15 STEARYL ETHER BENZOATE (UNII: 80D2J6361M)
PHENYLPROPANOL (UNII: 0F897O3O4M)
MYRISTYL ALCOHOL (UNII: V42034O9PU)
MYRISTYL GLUCOSIDE (UNII: 6AK28695LF)
PANTHENOL (UNII: WV9CM0O67Z)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:82141-2335-1	1 in 1 CARTON	10/01/2022
1		40 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M020	10/01/2022

TOTY ILUMINA CC CREAM 5W1
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82141-2340
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	9 g in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	6.3 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER (UNII: V5RS026Q0H)
1,3-BUTYLENE GLYCOL COCOATE (UNII: B2JUC5N9EH)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
MICA (UNII: V8A1AW0880)
STEARETH-21 (UNII: 53J3F32P58)
STEARETH-2 (UNII: V56DFE46J5)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHLEBODIUM AUREUM LEAF (UNII: BG58BW230G)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CETEARETH-25 (UNII: 8FA93U5T67)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
DIPROPYLENE GLYCOL DIBENZOATE (UNII: 6OA5ZDY41O)
PROPANEDIOL (UNII: 5965N8W85T)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DISODIUM ETHYLENE DICOCAMIDE PEG-15 DISULFATE (UNII: QI9A6U005W)
PPG-15 STEARYL ETHER BENZOATE (UNII: 80D2J6361M)
PHENYLPROPANOL (UNII: 0F897O3O4M)
PANTHENOL (UNII: WV9CM0O67Z)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:82141-2340-1	1 in 1 CARTON	10/01/2022
1		40 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M020	10/01/2022

TOTY ILUMINA CC CREAM 5W2
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82141-2341
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	9 g in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	6.3 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER (UNII: V5RS026Q0H)
1,3-BUTYLENE GLYCOL COCOATE (UNII: B2JUC5N9EH)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
MICA (UNII: V8A1AW0880)
STEARETH-21 (UNII: 53J3F32P58)
STEARETH-2 (UNII: V56DFE46J5)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHLEBODIUM AUREUM LEAF (UNII: BG58BW230G)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CETEARETH-25 (UNII: 8FA93U5T67)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
DIPROPYLENE GLYCOL DIBENZOATE (UNII: 6OA5ZDY41O)
PROPANEDIOL (UNII: 5965N8W85T)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DISODIUM ETHYLENE DICOCAMIDE PEG-15 DISULFATE (UNII: QI9A6U005W)
PPG-15 STEARYL ETHER BENZOATE (UNII: 80D2J6361M)
PHENYLPROPANOL (UNII: 0F897O3O4M)
PANTHENOL (UNII: WV9CM0O67Z)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:82141-2341-1	1 in 1 CARTON	10/01/2022
1		40 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M020	10/01/2022

TOTY ILUMINA CC CREAM 3W
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82141-2334
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	9 g in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	6.3 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
1,3-BUTYLENE GLYCOL COCOATE (UNII: B2JUC5N9EH)
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER (UNII: V5RS026Q0H)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHLEBODIUM AUREUM LEAF (UNII: BG58BW230G)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
COCO GLUCOSIDE (UNII: ICS790225B)
WATER (UNII: 059QF0KO0R)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CETEARETH-25 (UNII: 8FA93U5T67)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
DIPROPYLENE GLYCOL DIBENZOATE (UNII: 6OA5ZDY41O)
PROPANEDIOL (UNII: 5965N8W85T)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DISODIUM ETHYLENE DICOCAMIDE PEG-15 DISULFATE (UNII: QI9A6U005W)
PPG-15 STEARYL ETHER BENZOATE (UNII: 80D2J6361M)
PHENYLPROPANOL (UNII: 0F897O3O4M)
MYRISTYL ALCOHOL (UNII: V42034O9PU)
MYRISTYL GLUCOSIDE (UNII: 6AK28695LF)
PANTHENOL (UNII: WV9CM0O67Z)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:82141-2334-1	1 in 1 CARTON	10/01/2022
1		40 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M020	10/01/2022

TOTY ILUMINA CC CREAM 4N
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82141-2336
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	9 g in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	6.3 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER (UNII: V5RS026Q0H)
1,3-BUTYLENE GLYCOL COCOATE (UNII: B2JUC5N9EH)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHLEBODIUM AUREUM LEAF (UNII: BG58BW230G)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
COCO GLUCOSIDE (UNII: ICS790225B)
WATER (UNII: 059QF0KO0R)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CETEARETH-25 (UNII: 8FA93U5T67)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
DIPROPYLENE GLYCOL DIBENZOATE (UNII: 6OA5ZDY41O)
PROPANEDIOL (UNII: 5965N8W85T)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DISODIUM ETHYLENE DICOCAMIDE PEG-15 DISULFATE (UNII: QI9A6U005W)
PPG-15 STEARYL ETHER BENZOATE (UNII: 80D2J6361M)
PHENYLPROPANOL (UNII: 0F897O3O4M)
MYRISTYL ALCOHOL (UNII: V42034O9PU)
MYRISTYL GLUCOSIDE (UNII: 6AK28695LF)
PANTHENOL (UNII: WV9CM0O67Z)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:82141-2336-1	1 in 1 CARTON	10/01/2022
1		40 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M020	10/01/2022

TOTY ILUMINA CC CREAM 5W
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82141-2339
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	9 g in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	6.3 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
1,3-BUTYLENE GLYCOL COCOATE (UNII: B2JUC5N9EH)
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER (UNII: V5RS026Q0H)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
MICA (UNII: V8A1AW0880)
STEARETH-21 (UNII: 53J3F32P58)
STEARETH-2 (UNII: V56DFE46J5)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHLEBODIUM AUREUM LEAF (UNII: BG58BW230G)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CETEARETH-25 (UNII: 8FA93U5T67)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
DIPROPYLENE GLYCOL DIBENZOATE (UNII: 6OA5ZDY41O)
PROPANEDIOL (UNII: 5965N8W85T)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DISODIUM ETHYLENE DICOCAMIDE PEG-15 DISULFATE (UNII: QI9A6U005W)
PPG-15 STEARYL ETHER BENZOATE (UNII: 80D2J6361M)
PHENYLPROPANOL (UNII: 0F897O3O4M)
PANTHENOL (UNII: WV9CM0O67Z)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:82141-2339-1	1 in 1 CARTON	10/01/2022
1		40 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M020	10/01/2022

TOTY ILUMINA CC CREAM 3N
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82141-2333
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	9 g in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	6.3 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
1,3-BUTYLENE GLYCOL COCOATE (UNII: B2JUC5N9EH)
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER (UNII: V5RS026Q0H)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHLEBODIUM AUREUM LEAF (UNII: BG58BW230G)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
COCO GLUCOSIDE (UNII: ICS790225B)
WATER (UNII: 059QF0KO0R)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CETEARETH-25 (UNII: 8FA93U5T67)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
DIPROPYLENE GLYCOL DIBENZOATE (UNII: 6OA5ZDY41O)
PROPANEDIOL (UNII: 5965N8W85T)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DISODIUM ETHYLENE DICOCAMIDE PEG-15 DISULFATE (UNII: QI9A6U005W)
PPG-15 STEARYL ETHER BENZOATE (UNII: 80D2J6361M)
PHENYLPROPANOL (UNII: 0F897O3O4M)
MYRISTYL ALCOHOL (UNII: V42034O9PU)
MYRISTYL GLUCOSIDE (UNII: 6AK28695LF)
PANTHENOL (UNII: WV9CM0O67Z)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:82141-2333-1	1 in 1 CARTON	10/01/2022
1		40 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M020	10/01/2022

TOTY ILUMINA CC CREAM 4W
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82141-2337
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	9 g in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	6.3 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER (UNII: V5RS026Q0H)
1,3-BUTYLENE GLYCOL COCOATE (UNII: B2JUC5N9EH)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
MICA (UNII: V8A1AW0880)
STEARETH-21 (UNII: 53J3F32P58)
STEARETH-2 (UNII: V56DFE46J5)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHLEBODIUM AUREUM LEAF (UNII: BG58BW230G)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CETEARETH-25 (UNII: 8FA93U5T67)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
DIPROPYLENE GLYCOL DIBENZOATE (UNII: 6OA5ZDY41O)
PROPANEDIOL (UNII: 5965N8W85T)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DISODIUM ETHYLENE DICOCAMIDE PEG-15 DISULFATE (UNII: QI9A6U005W)
PPG-15 STEARYL ETHER BENZOATE (UNII: 80D2J6361M)
PHENYLPROPANOL (UNII: 0F897O3O4M)
PANTHENOL (UNII: WV9CM0O67Z)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:82141-2337-1	1 in 1 CARTON	10/01/2022
1		40 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M020	10/01/2022

TOTY ILUMINA CC CREAM 2C
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82141-2332
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	9 g in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	6.3 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
1,3-BUTYLENE GLYCOL COCOATE (UNII: B2JUC5N9EH)
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER (UNII: V5RS026Q0H)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHLEBODIUM AUREUM LEAF (UNII: BG58BW230G)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
COCO GLUCOSIDE (UNII: ICS790225B)
WATER (UNII: 059QF0KO0R)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CETEARETH-25 (UNII: 8FA93U5T67)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
DIPROPYLENE GLYCOL DIBENZOATE (UNII: 6OA5ZDY41O)
PROPANEDIOL (UNII: 5965N8W85T)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DISODIUM ETHYLENE DICOCAMIDE PEG-15 DISULFATE (UNII: QI9A6U005W)
PPG-15 STEARYL ETHER BENZOATE (UNII: 80D2J6361M)
PHENYLPROPANOL (UNII: 0F897O3O4M)
MYRISTYL ALCOHOL (UNII: V42034O9PU)
MYRISTYL GLUCOSIDE (UNII: 6AK28695LF)
PANTHENOL (UNII: WV9CM0O67Z)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:82141-2332-1	1 in 1 CARTON	10/01/2022
1		40 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M020	10/01/2022

TOTY ILUMINA CC CREAM 2W
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82141-2331
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	9 g in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	6.3 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER (UNII: V5RS026Q0H)
1,3-BUTYLENE GLYCOL COCOATE (UNII: B2JUC5N9EH)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHLEBODIUM AUREUM LEAF (UNII: BG58BW230G)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
COCO GLUCOSIDE (UNII: ICS790225B)
WATER (UNII: 059QF0KO0R)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CETEARETH-25 (UNII: 8FA93U5T67)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
DIPROPYLENE GLYCOL DIBENZOATE (UNII: 6OA5ZDY41O)
PROPANEDIOL (UNII: 5965N8W85T)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DISODIUM ETHYLENE DICOCAMIDE PEG-15 DISULFATE (UNII: QI9A6U005W)
PPG-15 STEARYL ETHER BENZOATE (UNII: 80D2J6361M)
PHENYLPROPANOL (UNII: 0F897O3O4M)
MYRISTYL ALCOHOL (UNII: V42034O9PU)
MYRISTYL GLUCOSIDE (UNII: 6AK28695LF)
PANTHENOL (UNII: WV9CM0O67Z)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:82141-2331-1	1 in 1 CARTON	10/01/2022
1		40 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M020	10/01/2022

Labeler - Chipican LLC (118132015)

Name	Address	ID/FEI	Business Operations
Establishment
Industrial Farmaceutica Cantabria SA		470471158	manufacture(82141-2327, 82141-2328, 82141-2329, 82141-2330, 82141-2331, 82141-2332, 82141-2333, 82141-2334, 82141-2335, 82141-2336, 82141-2337, 82141-2338, 82141-2339, 82141-2340, 82141-2341) , pack(82141-2327, 82141-2328, 82141-2329, 82141-2330, 82141-2331, 82141-2332, 82141-2333, 82141-2334, 82141-2335, 82141-2336, 82141-2337, 82141-2338, 82141-2339, 82141-2340, 82141-2341) , label(82141-2327, 82141-2328, 82141-2329, 82141-2330, 82141-2331, 82141-2332, 82141-2333, 82141-2334, 82141-2335, 82141-2336, 82141-2337, 82141-2338, 82141-2339, 82141-2340, 82141-2341)

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	NDC
1	82141-2327-1
2	82141-2328-1
3	82141-2329-1
4	82141-2330-1
5	82141-2331-1
6	82141-2332-1
7	82141-2333-1
8	82141-2334-1
9	82141-2335-1
10	82141-2336-1
11	82141-2337-1
12	82141-2338-1
13	82141-2339-1
14	82141-2340-1
15	82141-2341-1

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