Label: EVE LOM BRILLIANT COVER CONCEALER BROAD SPECTRUM SPF 15 SUNSCREEN- titanium dioxide and octinoxate cream
-
Contains inactivated NDC Code(s)
NDC Code(s): 61601-1139-9, 61601-1140-1, 61601-1141-3, 61601-1142-2, view more61601-1143-2, 61601-1144-0 - 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.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
- Warnings
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
- 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
ethylhexyl stearate, isononyl isononanoate, tribehenin, talc, caprylic/capric triglyceride, hydrogenated coco-glycerides, stearalkonium bentonite, hydrogenated polyisobutene, propylene carbonate, hydrogenated vegetable oil, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, nylon-12 fluorescent brightener 230 salt, hydrogenated styrene/isoprene copolymer, crithmum maritimum extract, polyvinylalcohol crosspolymer, BHT, rubus idaeus leaf cell culture.
May contain: titanium dioxide, iron oxides.
- Other information
- PRINCIPAL DISPLAY PANEL - 2 g Container Carton - Alabaster
- PRINCIPAL DISPLAY PANEL - 2 g Container Carton - Ivory
- PRINCIPAL DISPLAY PANEL - 2 g Container Carton - Linen
- PRINCIPAL DISPLAY PANEL - 2 g Container Carton - Beige
- PRINCIPAL DISPLAY PANEL - 2 g Container Carton - Wheat
- PRINCIPAL DISPLAY PANEL - 2 g Container Carton - Glow
-
INGREDIENTS AND APPEARANCE
EVE LOM BRILLIANT COVER CONCEALER BROAD SPECTRUM SPF 15 SUNSCREEN
titanium dioxide and octinoxate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61601-1139 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.08 g in 2 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.078 g in 2 g Inactive Ingredients Ingredient Name Strength ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5) ISONONYL ISONONANOATE (UNII: S4V5BS6GCX) TRIBEHENIN (UNII: 8OC9U7TQZ0) TALC (UNII: 7SEV7J4R1U) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) FERRIC OXIDE RED (UNII: 1K09F3G675) PROPYLENE CARBONATE (UNII: 8D08K3S51E) FERROSOFERRIC OXIDE (UNII: XM0M87F357) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) CRITHMUM MARITIMUM (UNII: J7IHY79BKY) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) Product Characteristics Color white (Alabaster) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61601-1139-9 1 in 1 CARTON 1 2 g in 1 CONTAINER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/01/2014 EVE LOM BRILLIANT COVER CONCEALER BROAD SPECTRUM SPF 15 SUNSCREEN
titanium dioxide and octinoxate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61601-1140 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.08 g in 2 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.078 g in 2 g Inactive Ingredients Ingredient Name Strength ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5) ISONONYL ISONONANOATE (UNII: S4V5BS6GCX) TRIBEHENIN (UNII: 8OC9U7TQZ0) TALC (UNII: 7SEV7J4R1U) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) FERRIC OXIDE RED (UNII: 1K09F3G675) PROPYLENE CARBONATE (UNII: 8D08K3S51E) FERROSOFERRIC OXIDE (UNII: XM0M87F357) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) CRITHMUM MARITIMUM (UNII: J7IHY79BKY) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) Product Characteristics Color white (Ivory) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61601-1140-1 1 in 1 CARTON 1 2 g in 1 CONTAINER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/01/2014 EVE LOM BRILLIANT COVER CONCEALER BROAD SPECTRUM SPF 15 SUNSCREEN
titanium dioxide and octinoxate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61601-1141 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.08 g in 2 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.078 g in 2 g Inactive Ingredients Ingredient Name Strength ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5) ISONONYL ISONONANOATE (UNII: S4V5BS6GCX) TRIBEHENIN (UNII: 8OC9U7TQZ0) TALC (UNII: 7SEV7J4R1U) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) FERRIC OXIDE RED (UNII: 1K09F3G675) PROPYLENE CARBONATE (UNII: 8D08K3S51E) FERROSOFERRIC OXIDE (UNII: XM0M87F357) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) CRITHMUM MARITIMUM (UNII: J7IHY79BKY) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) Product Characteristics Color brown (Beige) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61601-1141-3 1 in 1 CARTON 1 2 g in 1 CONTAINER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/01/2014 EVE LOM BRILLIANT COVER CONCEALER BROAD SPECTRUM SPF 15 SUNSCREEN
titanium dioxide and octinoxate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61601-1142 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.08 g in 2 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.078 g in 2 g Inactive Ingredients Ingredient Name Strength ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5) ISONONYL ISONONANOATE (UNII: S4V5BS6GCX) TRIBEHENIN (UNII: 8OC9U7TQZ0) TALC (UNII: 7SEV7J4R1U) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) FERRIC OXIDE RED (UNII: 1K09F3G675) PROPYLENE CARBONATE (UNII: 8D08K3S51E) FERROSOFERRIC OXIDE (UNII: XM0M87F357) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) CRITHMUM MARITIMUM (UNII: J7IHY79BKY) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) Product Characteristics Color white (Linen) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61601-1142-2 1 in 1 CARTON 1 2 g in 1 CONTAINER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/01/2014 EVE LOM BRILLIANT COVER CONCEALER BROAD SPECTRUM SPF 15 SUNSCREEN
titanium dioxide and octinoxate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61601-1143 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.08 g in 2 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.078 g in 2 g Inactive Ingredients Ingredient Name Strength ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5) ISONONYL ISONONANOATE (UNII: S4V5BS6GCX) TRIBEHENIN (UNII: 8OC9U7TQZ0) TALC (UNII: 7SEV7J4R1U) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) FERRIC OXIDE RED (UNII: 1K09F3G675) PROPYLENE CARBONATE (UNII: 8D08K3S51E) FERROSOFERRIC OXIDE (UNII: XM0M87F357) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) CRITHMUM MARITIMUM (UNII: J7IHY79BKY) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) Product Characteristics Color brown (Wheat) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61601-1143-2 1 in 1 CARTON 1 2 g in 1 CONTAINER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/01/2014 EVE LOM BRILLIANT COVER CONCEALER BROAD SPECTRUM SPF 15 SUNSCREEN
titanium dioxide and octinoxate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61601-1144 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.08 g in 2 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.078 g in 2 g Inactive Ingredients Ingredient Name Strength ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5) ISONONYL ISONONANOATE (UNII: S4V5BS6GCX) TRIBEHENIN (UNII: 8OC9U7TQZ0) TALC (UNII: 7SEV7J4R1U) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) FERRIC OXIDE RED (UNII: 1K09F3G675) PROPYLENE CARBONATE (UNII: 8D08K3S51E) FERROSOFERRIC OXIDE (UNII: XM0M87F357) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) CRITHMUM MARITIMUM (UNII: J7IHY79BKY) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) Product Characteristics Color brown (Glow) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61601-1144-0 1 in 1 CARTON 1 2 g in 1 CONTAINER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/01/2014 Labeler - Space Brands Limited (218214381)
