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

Eve Lom Radiance Perfected Tinted Moisturiser SPF 15 by

Drug Labeling and Warnings

Eve Lom Radiance Perfected Tinted Moisturiser SPF 15 by is a Otc medication manufactured, distributed, or labeled by Space Brands Limited, Intercos Europe S.p.A.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 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 - 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 - 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 - Honey 12

EVE
LOM®

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

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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

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

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

Labeler - Space Brands Limited (218214381)

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