DailyMed - EVE LOM RADIANCE PERFECTED TINTED MOISTURISER BROAD SPECTRUM SPF 15 SUNSCREEN- titanium dioxide and octinoxate cream

Contains inactivated NDC Code(s)
NDC Code(s): 61601-1112-6, 61601-1113-9, 61601-1114-4, 61601-1115-6, view more
61601-1116-7, 61601-1117-3, 61601-1118-8, 61601-1119-9, 61601-1120-2, 61601-1121-8, 61601-1122-5, 61601-1123-7
Packager: Space Brands Limited

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None
Marketing Status: OTC monograph not 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 March 20, 2014

If you are a consumer or patient please visit this version.

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Official Label (Printer Friendly)

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SPL UNCLASSIFIED SECTION

Drug Facts
ACTIVE INGREDIENT

Active Ingredients                   Purpose

Octinoxate 5%                        Sunscreen

Titanium Dioxide 6.2%             Sunscreen
Uses
- helps prevent sunburn
- if used as directed with other sun protection measure (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
Warnings

For external use only
DO NOT USE

Do not use on damaged or broken skin
WHEN USING

When using this product keep out of eyes. Rinse with water to remove.
STOP USE

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.
Directions
- apply liberally 15 minutes before sun exposure
- children under 6 months of age: Ask a doctor
- reapply at least every 2 hours
- use a water-resistant sunscreen if swimming or sweating
- Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
  - limit time in the sun, especially from 10 a.m. – 2 p.m.
  - wear long-sleeve shirts, pants, hats, and sunglasses
INACTIVE INGREDIENT

water, dimethicone, c 12-15 alkly benzoate, propylene glycol dicaprylate/dicaprate, glycerin, isododecane, butylene glycol, silica, talc, cetyl PEG/PPG-10/1 dimethicone, synthetic beeswax, polyglyceryl-3 diisostearate, sodium chloride, phenoxyethanol, zinc stearate, caprylic/capric triglyceride, disodium EDTA, disteardimonium hectorite, triethoxycaprylylsilane, sodium dehydroacetate, chlorphenesin, tocopheryl acetate, alcohol, ascorbyl palmitate, aluminum hydroxide, sodium hyaluronate, pancratium maritimum extract, rubus idaeus leaf cell culture.

May contain: titanium dioxide, iron oxides.
Other information
- protect this product from excessive heat and direct sun
PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - Alabaster

EVE LOM®

RADIANCE PERFECTED

TINTED MOISTURISER

BROAD SPECTRUM SPF 15

SUNSCREEN

ALABASTER 1

50 ml 1.7 FL. OZ e
PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - Ivory

EVE LOM®

RADIANCE PERFECTED

TINTED MOISTURISER

BROAD SPECTRUM SPF 15

SUNSCREEN

IVORY 2

50 ml 1.7 FL. OZ e
PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - Ecru

EVE LOM®

RADIANCE PERFECTED

TINTED MOISTURISER

BROAD SPECTRUM SPF 15

SUNSCREEN

ECRU 3

50 ml 1.7 FL. OZ e
PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - Vanilla

EVE LOM®

RADIANCE PERFECTED

TINTED MOISTURISER

BROAD SPECTRUM SPF 15

SUNSCREEN

VANILLA 4

50 ml 1.7 FL. OZ e
PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - Linen

EVE LOM®

RADIANCE PERFECTED

TINTED MOISTURISER

BROAD SPECTRUM SPF 15

SUNSCREEN

LINEN 5

50 ml 1.7 FL. OZ e
PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - Cream

EVE LOM®

RADIANCE PERFECTED

TINTED MOISTURISER

BROAD SPECTRUM SPF 15

SUNSCREEN

CREAM 6

50 ml 1.7 FL. OZ e
PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - Beige

EVE LOM®

RADIANCE PERFECTED

TINTED MOISTURISER

BROAD SPECTRUM SPF 15

SUNSCREEN

BEIGE 7

50 ml 1.7 FL. OZ e
PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - Petal

EVE LOM®

RADIANCE PERFECTED

TINTED MOISTURISER

BROAD SPECTRUM SPF 15

SUNSCREEN

PETAL 8

50 ml 1.7 FL. OZ e
PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - Wheat

EVE LOM®

RADIANCE PERFECTED

TINTED MOISTURISER

BROAD SPECTRUM SPF 15

SUNSCREEN

WHEAT 9

50 ml 1.7 FL. OZ e
PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - Bamboo

EVE LOM®

RADIANCE PERFECTED

TINTED MOISTURISER

BROAD SPECTRUM SPF 15

SUNSCREEN

BAMBOO 10

50 ml 1.7 FL. OZ e
PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - Glow

EVE LOM®

RADIANCE PERFECTED

TINTED MOISTURISER

BROAD SPECTRUM SPF 15

SUNSCREEN

GLOW 11

50 ml 1.7 FL. OZ e
PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - Honey

EVE LOM®

RADIANCE PERFECTED

TINTED MOISTURISER

BROAD SPECTRUM SPF 15

SUNSCREEN

HONEY 12

50 ml 1.7 FL. OZ e

INGREDIENTS AND APPEARANCE

EVE LOM RADIANCE PERFECTED TINTED MOISTURISER BROAD SPECTRUM SPF 15 SUNSCREEN
titanium dioxide and octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61601-1112
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.1 g in 50 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.5 g in 50 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: O4446S9CRA)
GLYCERIN (UNII: PDC6A3C0OX)
ISODODECANE (UNII: A8289P68Y2)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TALC (UNII: 7SEV7J4R1U)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ZINC STEARATE (UNII: H92E6QA4FV)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
EDETATE SODIUM (UNII: MP1J8420LU)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
CHLORPHENESIN (UNII: I670DAL4SZ)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALCOHOL (UNII: 3K9958V90M)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
FERRIC OXIDE RED (UNII: 1K09F3G675)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

Product Characteristics
Color	white (Alabaster)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:61601-1112-6	1 in 1 CARTON
1		50 mL in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	03/01/2014

EVE LOM RADIANCE PERFECTED TINTED MOISTURISER BROAD SPECTRUM SPF 15 SUNSCREEN
titanium dioxide and octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61601-1113
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.1 g in 50 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.5 g in 50 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: O4446S9CRA)
GLYCERIN (UNII: PDC6A3C0OX)
ISODODECANE (UNII: A8289P68Y2)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TALC (UNII: 7SEV7J4R1U)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ZINC STEARATE (UNII: H92E6QA4FV)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
EDETATE SODIUM (UNII: MP1J8420LU)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
CHLORPHENESIN (UNII: I670DAL4SZ)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALCOHOL (UNII: 3K9958V90M)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
FERRIC OXIDE RED (UNII: 1K09F3G675)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

Product Characteristics
Color	white (Ivory)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:61601-1113-9	1 in 1 CARTON
1		50 mL in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	03/01/2014

EVE LOM RADIANCE PERFECTED TINTED MOISTURISER BROAD SPECTRUM SPF 15 SUNSCREEN
titanium dioxide and octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61601-1114
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.1 g in 50 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.5 g in 50 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: O4446S9CRA)
GLYCERIN (UNII: PDC6A3C0OX)
ISODODECANE (UNII: A8289P68Y2)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TALC (UNII: 7SEV7J4R1U)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ZINC STEARATE (UNII: H92E6QA4FV)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
EDETATE SODIUM (UNII: MP1J8420LU)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
CHLORPHENESIN (UNII: I670DAL4SZ)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALCOHOL (UNII: 3K9958V90M)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
FERRIC OXIDE RED (UNII: 1K09F3G675)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

Product Characteristics
Color	white (Ecru)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:61601-1114-4	1 in 1 CARTON
1		50 mL in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	03/01/2014

EVE LOM RADIANCE PERFECTED TINTED MOISTURISER BROAD SPECTRUM SPF 15 SUNSCREEN
titanium dioxide and octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61601-1115
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.1 g in 50 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.5 g in 50 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: O4446S9CRA)
GLYCERIN (UNII: PDC6A3C0OX)
ISODODECANE (UNII: A8289P68Y2)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TALC (UNII: 7SEV7J4R1U)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ZINC STEARATE (UNII: H92E6QA4FV)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
EDETATE SODIUM (UNII: MP1J8420LU)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
CHLORPHENESIN (UNII: I670DAL4SZ)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALCOHOL (UNII: 3K9958V90M)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
FERRIC OXIDE RED (UNII: 1K09F3G675)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

Product Characteristics
Color	yellow (Vanilla)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:61601-1115-6	1 in 1 CARTON
1		50 mL in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	03/01/2014

EVE LOM RADIANCE PERFECTED TINTED MOISTURISER BROAD SPECTRUM SPF 15 SUNSCREEN
titanium dioxide and octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61601-1116
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.1 g in 50 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.5 g in 50 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: O4446S9CRA)
GLYCERIN (UNII: PDC6A3C0OX)
ISODODECANE (UNII: A8289P68Y2)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TALC (UNII: 7SEV7J4R1U)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ZINC STEARATE (UNII: H92E6QA4FV)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
EDETATE SODIUM (UNII: MP1J8420LU)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
CHLORPHENESIN (UNII: I670DAL4SZ)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALCOHOL (UNII: 3K9958V90M)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
FERRIC OXIDE RED (UNII: 1K09F3G675)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

Product Characteristics
Color	white (Linen)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:61601-1116-7	1 in 1 CARTON
1		50 mL in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	03/01/2014

EVE LOM RADIANCE PERFECTED TINTED MOISTURISER BROAD SPECTRUM SPF 15 SUNSCREEN
titanium dioxide and octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61601-1117
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.1 g in 50 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.5 g in 50 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: O4446S9CRA)
GLYCERIN (UNII: PDC6A3C0OX)
ISODODECANE (UNII: A8289P68Y2)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TALC (UNII: 7SEV7J4R1U)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ZINC STEARATE (UNII: H92E6QA4FV)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
EDETATE SODIUM (UNII: MP1J8420LU)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
CHLORPHENESIN (UNII: I670DAL4SZ)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALCOHOL (UNII: 3K9958V90M)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
FERRIC OXIDE RED (UNII: 1K09F3G675)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

Product Characteristics
Color	white (Cream)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:61601-1117-3	1 in 1 CARTON
1		50 mL in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	03/01/2014

EVE LOM RADIANCE PERFECTED TINTED MOISTURISER BROAD SPECTRUM SPF 15 SUNSCREEN
titanium dioxide and octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61601-1118
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.1 g in 50 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.5 g in 50 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: O4446S9CRA)
GLYCERIN (UNII: PDC6A3C0OX)
ISODODECANE (UNII: A8289P68Y2)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TALC (UNII: 7SEV7J4R1U)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ZINC STEARATE (UNII: H92E6QA4FV)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
EDETATE SODIUM (UNII: MP1J8420LU)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
CHLORPHENESIN (UNII: I670DAL4SZ)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALCOHOL (UNII: 3K9958V90M)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
FERRIC OXIDE RED (UNII: 1K09F3G675)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

Product Characteristics
Color	brown (Beige)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:61601-1118-8	1 in 1 CARTON
1		50 mL in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	03/01/2014

EVE LOM RADIANCE PERFECTED TINTED MOISTURISER BROAD SPECTRUM SPF 15 SUNSCREEN
titanium dioxide and octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61601-1119
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.1 g in 50 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.5 g in 50 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: O4446S9CRA)
GLYCERIN (UNII: PDC6A3C0OX)
ISODODECANE (UNII: A8289P68Y2)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TALC (UNII: 7SEV7J4R1U)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ZINC STEARATE (UNII: H92E6QA4FV)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
EDETATE SODIUM (UNII: MP1J8420LU)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
CHLORPHENESIN (UNII: I670DAL4SZ)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALCOHOL (UNII: 3K9958V90M)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
FERRIC OXIDE RED (UNII: 1K09F3G675)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

Product Characteristics
Color	pink (Petal)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:61601-1119-9	1 in 1 CARTON
1		50 mL in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	03/01/2014

EVE LOM RADIANCE PERFECTED TINTED MOISTURISER BROAD SPECTRUM SPF 15 SUNSCREEN
titanium dioxide and octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61601-1120
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.1 g in 50 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.5 g in 50 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: O4446S9CRA)
GLYCERIN (UNII: PDC6A3C0OX)
ISODODECANE (UNII: A8289P68Y2)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TALC (UNII: 7SEV7J4R1U)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ZINC STEARATE (UNII: H92E6QA4FV)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
EDETATE SODIUM (UNII: MP1J8420LU)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
CHLORPHENESIN (UNII: I670DAL4SZ)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALCOHOL (UNII: 3K9958V90M)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
FERRIC OXIDE RED (UNII: 1K09F3G675)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

Product Characteristics
Color	brown (Wheat)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:61601-1120-2	1 in 1 CARTON
1		50 mL in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	03/01/2014

EVE LOM RADIANCE PERFECTED TINTED MOISTURISER BROAD SPECTRUM SPF 15 SUNSCREEN
titanium dioxide and octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61601-1121
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.1 g in 50 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.5 g in 50 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: O4446S9CRA)
GLYCERIN (UNII: PDC6A3C0OX)
ISODODECANE (UNII: A8289P68Y2)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TALC (UNII: 7SEV7J4R1U)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ZINC STEARATE (UNII: H92E6QA4FV)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
EDETATE SODIUM (UNII: MP1J8420LU)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
CHLORPHENESIN (UNII: I670DAL4SZ)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALCOHOL (UNII: 3K9958V90M)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
FERRIC OXIDE RED (UNII: 1K09F3G675)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

Product Characteristics
Color	brown (Bamboo)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:61601-1121-8	1 in 1 CARTON
1		50 mL in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	03/01/2014

EVE LOM RADIANCE PERFECTED TINTED MOISTURISER BROAD SPECTRUM SPF 15 SUNSCREEN
titanium dioxide and octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61601-1122
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.1 g in 50 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.5 g in 50 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: O4446S9CRA)
GLYCERIN (UNII: PDC6A3C0OX)
ISODODECANE (UNII: A8289P68Y2)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TALC (UNII: 7SEV7J4R1U)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ZINC STEARATE (UNII: H92E6QA4FV)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
EDETATE SODIUM (UNII: MP1J8420LU)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
CHLORPHENESIN (UNII: I670DAL4SZ)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALCOHOL (UNII: 3K9958V90M)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
FERRIC OXIDE RED (UNII: 1K09F3G675)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

Product Characteristics
Color	white (Glow)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:61601-1122-5	1 in 1 CARTON
1		50 mL in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	03/01/2014

EVE LOM RADIANCE PERFECTED TINTED MOISTURISER BROAD SPECTRUM SPF 15 SUNSCREEN
titanium dioxide and octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61601-1123
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.1 g in 50 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.5 g in 50 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: O4446S9CRA)
GLYCERIN (UNII: PDC6A3C0OX)
ISODODECANE (UNII: A8289P68Y2)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TALC (UNII: 7SEV7J4R1U)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ZINC STEARATE (UNII: H92E6QA4FV)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
EDETATE SODIUM (UNII: MP1J8420LU)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
CHLORPHENESIN (UNII: I670DAL4SZ)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALCOHOL (UNII: 3K9958V90M)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
FERRIC OXIDE RED (UNII: 1K09F3G675)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

Product Characteristics
Color	brown (Honey)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:61601-1123-7	1 in 1 CARTON
1		50 mL in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	03/01/2014

Labeler - Space Brands Limited (218214381)

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	NDC
1	61601-1112-6 (inactivated)
2	61601-1113-9 (inactivated)
3	61601-1114-4 (inactivated)
4	61601-1115-6 (inactivated)
5	61601-1116-7 (inactivated)
6	61601-1117-3 (inactivated)
7	61601-1118-8 (inactivated)
8	61601-1119-9 (inactivated)
9	61601-1120-2 (inactivated)
10	61601-1121-8 (inactivated)
11	61601-1122-5 (inactivated)
12	61601-1123-7 (inactivated)

Label: EVE LOM RADIANCE PERFECTED TINTED MOISTURISER BROAD SPECTRUM SPF 15 SUNSCREEN- titanium dioxide and octinoxate cream

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Label: EVE LOM RADIANCE PERFECTED TINTED MOISTURISER BROAD SPECTRUM SPF 15 SUNSCREEN- titanium dioxide and octinoxate cream

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EVE LOM RADIANCE PERFECTED TINTED MOISTURISER BROAD SPECTRUM SPF 15 SUNSCREEN- titanium dioxide and octinoxate cream

Number of versions: 1

EVE LOM RADIANCE PERFECTED TINTED MOISTURISER BROAD SPECTRUM SPF 15 SUNSCREEN- titanium dioxide and octinoxate cream

EVE LOM RADIANCE PERFECTED TINTED MOISTURISER BROAD SPECTRUM SPF 15 SUNSCREEN- titanium dioxide and octinoxate cream

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EVE LOM RADIANCE PERFECTED TINTED MOISTURISER BROAD SPECTRUM SPF 15 SUNSCREEN- titanium dioxide and octinoxate cream

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.