Drug Facts

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 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. 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 ingredients

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 - Ivory 2

EVE
LOM®

RADIANCE PERFECTED
TINTED MOISTURISER
BROAD SPECTRUM SPF 15
SUNSCREEN
IVORY 2
50ml 1.7 FL. OZ. e

Principal Display Panel - 50 ml Tube Carton - Ivory 2

PRINCIPAL DISPLAY PANEL - 50 ml Tube Carton - Beige 7

EVE
LOM®

RADIANCE PERFECTED
TINTED MOISTURISER
BROAD SPECTRUM SPF 15
SUNSCREEN
BEIGE 7
50ml 1.7 FL. OZ. e

Principal Display Panel - 50 ml Tube Carton - Beige 7

PRINCIPAL DISPLAY PANEL - 50 ml Tube Carton - Bamboo 10

EVE
LOM®

RADIANCE PERFECTED
TINTED MOISTURISER
BROAD SPECTRUM SPF 15
SUNSCREEN
BAMBOO 10
50ml 1.7 FL. OZ. e

Principal Display Panel - 50 ml Tube Carton - Bamboo 10

PRINCIPAL DISPLAY PANEL - 50 ml Tube Carton - Honey 12

EVE
LOM®

RADIANCE PERFECTED
TINTED MOISTURISER
BROAD SPECTRUM SPF 15
SUNSCREEN
HONEY 12
50ml 1.7 FL. OZ. e

Principal Display Panel - 50 ml Tube Carton - Honey 12

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61601-1193
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 2)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:61601-1193-9	1 in 1 CARTON
1		2 mL in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	02/28/2014

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61601-1194
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 (Biege 7)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:61601-1194-8	1 in 1 CARTON
1		2 mL in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	02/28/2014

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61601-1195
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 10)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:61601-1195-8	1 in 1 CARTON
1		2 mL in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	02/28/2014

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61601-1196
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 12)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:61601-1196-7	1 in 1 CARTON
1		2 mL in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	02/28/2014

Labeler - Space Brands Limited (218214381)

Name	Address	ID/FEI	Business Operations
Establishment
Intercos Europe S.p.A.		438961310	MANUFACTURE(61601-1193, 61601-1194, 61601-1195, 61601-1196)

Eve Lom® Radiance Perfected Tinted Moisturiser SPF 15

Uses

Warnings

Directions

Inactive ingredients

Other information

PRINCIPAL DISPLAY PANEL - 50 ml Tube Carton - Ivory 2

PRINCIPAL DISPLAY PANEL - 50 ml Tube Carton - Beige 7

PRINCIPAL DISPLAY PANEL - 50 ml Tube Carton - Bamboo 10

PRINCIPAL DISPLAY PANEL - 50 ml Tube Carton - Honey 12