NDC | 61601-1193-9, 61601-1194-8, 61601-1195-8, 61601-1196-7 |
Set ID | 6977c06f-d7f0-4f3b-b800-beecb5ebf81c |
Category | HUMAN OTC DRUG LABEL |
Packager | Space Brands Limited |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
-
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
-
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
- 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
-
INGREDIENTS AND APPEARANCE
EVE LOM RADIANCE PERFECTED TINTED MOISTURISER SPF 15
titanium dioxide and octinoxate creamProduct 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 creamProduct 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 creamProduct 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 creamProduct 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)