Label: LIPSTICK QUEEN ENDLESS SUMMER BROAD SPECTRUM SPF 15 SUNSCREEN- homosalate, octinoxate, avobenzone and octocrylene lipstick
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Contains inactivated NDC Code(s)
NDC Code(s): 61601-0079-4, 61601-0080-1, 61601-0081-2, 61601-0082-3 - 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 June 5, 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
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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
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Inactive Ingredients (Aloha Shade)
Polyethylene, Ricinus Communis (Castor) Seed Oil, Vegetable Oil (Olus/Huile Vegetale), Hydrogenated Polyisobutene, Diisostearyl Malate, Perfluorononylethyl Stearyl Dimethicone, Isostearyl Hydroxystearate, Euphorbia Cerifera (Candelilla) Wax (Candelilla Cera/Cire De Candelilla), Triisostearyl Citrate, Silica, C12-15 Alkyl Lactate, Trimethylolpropane Triisostearate, Tridecyl Trimellitate, Hydrogenated Vegetable Oil, Caprylic/Capric Triglyceride, Hydrogenated Polycyclopentadiene, Phenoxyethanol, Tocopherol, Red 7 Lake (CI 15850), Red 30 Lake (CI 73360), Titanium Dioxide (CI 77891).
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Inactive Ingredients (Hang Ten Shade)
Polyethylene, Vegetable Oil (Olus/Huile Vegetale), Ricinus Communis (Castor) Seed Oil, Hydrogenated Polyisobutene, Diisostearyl Malate, Perfluorononylethyl Stearyl Dimethicone, Isostearyl Hydroxystearate, Euphorbia Cerifera (Candelilla) Wax (Candelilla Cera/Cire De Candelilla), Triisostearyl Citrate, C12-15 Alkyl Lactate, Silica, Trimethylolpropane Triisostearate, Tridecyl Trimellitate, Hydrogenated Vegetable Oil, Caprylic/Capric Triglyceride, Hydrogenated Polycyclopentadiene, Phenoxyethanol, Tocopherol, Red 7 Lake (CI 15850), Red 30 Lake (CI 73360), Iron Oxides (CI 77492, CI 77499), Titanium Dioxide (CI 77891).
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Inactive Ingredients (Perfect Wave Shade)
Polyethylene, Ricinus Communis (Castor) Seed Oil, Vegetable Oil (Olus/Huile Vegetale), Hydrogenated Polyisobutene, Diisostearyl Malate, Perfluorononylethyl Stearyl Dimethicone, Isostearyl Hydroxystearate, Euphorbia Cerifera (Candelilla) Wax (Candelilla Cera/Cire De Candelilla), Triisostearyl Citrate, C12-15 Alkyl Lactate, Silica, Trimethylolpropane Triisostearate, Tridecyl Trimellitate, Hydrogenated Vegetable Oil, Caprylic/Capric Triglyceride, Hydrogenated Polycyclopentadiene, Phenoxyethanol, Tocopherol, Red 6 (CI 15850), Yellow 6 Lake (CI 15985), Red 22 (CI 45380), Red 28 Lake (CI 45410), Titanium Dioxide (CI 77891).
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Inactive Ingredients (Stoked Shade)
Polyethylene, Vegetable Oil (Olus/Huile Vegetale), Hydrogenated Polyisobutene, Ricinus Communis (Castor) Seed Oil, Diisostearyl Malate, Perfluorononylethyl Stearyl Dimethicone, Isostearyl Hydroxystearate, Euphorbia Cerifera (Candelilla) Wax (Candelilla Cera/Cire De Candelilla), Triisostearyl Citrate, C12-15 Alkyl Lactate, Silica, Trimethylolpropane Triisostearate, Tridecyl Trimellitate, Hydrogenated Vegetable Oil, Caprylic/Capric Triglyceride, Hydrogenated Polycyclopentadiene, Phenoxyethanol, Tocopherol, Red 30 Lake (CI 73360), Iron Oxides (CI 77492), Titanium Dioxide (CI 77891).
- Other Information
- PRINCIPAL DISPLAY PANEL - Carton - Aloha
- PRINCIPAL DISPLAY PANEL - Carton - Hang Ten
- PRINCIPAL DISPLAY PANEL - Carton - Perfect Wave
- PRINCIPAL DISPLAY PANEL - Carton - Stoked
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INGREDIENTS AND APPEARANCE
LIPSTICK QUEEN ENDLESS SUMMER BROAD SPECTRUM SPF 15 SUNSCREEN
homosalate, octinoxate, avobenzone and octocrylene lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61601-0079 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 0.35 g in 3.5 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.14 g in 3.5 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 0.105 g in 3.5 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 0.07 g in 3.5 g Inactive Ingredients Ingredient Name Strength HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) CASTOR OIL (UNII: D5340Y2I9G) CORN OIL (UNII: 8470G57WFM) HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) ISOSTEARYL HYDROXYSTEARATE (UNII: F7540880P0) CANDELILLA WAX (UNII: WL0328HX19) TRIISOSTEARYL CITRATE (UNII: 50XT325OOH) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) C12-15 ALKYL LACTATE (UNII: GC844VRD7E) TRIMETHYLOLPROPANE TRIISOSTEARATE (UNII: Y32A6D7C6L) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) PHENOXYETHANOL (UNII: HIE492ZZ3T) TOCOPHEROL (UNII: R0ZB2556P8) D&C RED NO. 7 (UNII: ECW0LZ41X8) D&C RED NO. 30 (UNII: 2S42T2808B) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color red (Aloha) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61601-0079-4 1 in 1 CARTON 1 3.5 g in 1 APPLICATOR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 06/05/2014 LIPSTICK QUEEN ENDLESS SUMMER BROAD SPECTRUM SPF 15 SUNSCREEN
homosalate, octinoxate, avobenzone and octocrylene lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61601-0082 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 0.35 g in 3.5 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.14 g in 3.5 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 0.105 g in 3.5 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 0.07 g in 3.5 g Inactive Ingredients Ingredient Name Strength HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) CASTOR OIL (UNII: D5340Y2I9G) CORN OIL (UNII: 8470G57WFM) HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) ISOSTEARYL HYDROXYSTEARATE (UNII: F7540880P0) CANDELILLA WAX (UNII: WL0328HX19) TRIISOSTEARYL CITRATE (UNII: 50XT325OOH) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) C12-15 ALKYL LACTATE (UNII: GC844VRD7E) TRIMETHYLOLPROPANE TRIISOSTEARATE (UNII: Y32A6D7C6L) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) PHENOXYETHANOL (UNII: HIE492ZZ3T) TOCOPHEROL (UNII: R0ZB2556P8) D&C RED NO. 7 (UNII: ECW0LZ41X8) D&C RED NO. 30 (UNII: 2S42T2808B) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) Product Characteristics Color brown (Hang Ten) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61601-0082-3 1 in 1 CARTON 1 3.5 g in 1 APPLICATOR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 06/05/2014 LIPSTICK QUEEN ENDLESS SUMMER BROAD SPECTRUM SPF 15 SUNSCREEN
homosalate, octinoxate, avobenzone and octocrylene lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61601-0080 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 0.35 g in 3.5 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.14 g in 3.5 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 0.105 g in 3.5 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 0.07 g in 3.5 g Inactive Ingredients Ingredient Name Strength HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) CASTOR OIL (UNII: D5340Y2I9G) CORN OIL (UNII: 8470G57WFM) HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) ISOSTEARYL HYDROXYSTEARATE (UNII: F7540880P0) CANDELILLA WAX (UNII: WL0328HX19) TRIISOSTEARYL CITRATE (UNII: 50XT325OOH) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) C12-15 ALKYL LACTATE (UNII: GC844VRD7E) TRIMETHYLOLPROPANE TRIISOSTEARATE (UNII: Y32A6D7C6L) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) PHENOXYETHANOL (UNII: HIE492ZZ3T) TOCOPHEROL (UNII: R0ZB2556P8) D&C RED NO. 6 (UNII: 481744AI4O) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) D&C RED NO. 22 (UNII: 1678RKX8RT) D&C RED NO. 28 (UNII: 767IP0Y5NH) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color pink (Perfect Wave) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61601-0080-1 1 in 1 CARTON 1 3.5 g in 1 APPLICATOR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 06/05/2014 LIPSTICK QUEEN ENDLESS SUMMER BROAD SPECTRUM SPF 15 SUNSCREEN
homosalate, octinoxate, avobenzone and octocrylene lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61601-0081 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 0.35 g in 3.5 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.14 g in 3.5 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 0.105 g in 3.5 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 0.07 g in 3.5 g Inactive Ingredients Ingredient Name Strength HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) CASTOR OIL (UNII: D5340Y2I9G) CORN OIL (UNII: 8470G57WFM) HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) ISOSTEARYL HYDROXYSTEARATE (UNII: F7540880P0) CANDELILLA WAX (UNII: WL0328HX19) TRIISOSTEARYL CITRATE (UNII: 50XT325OOH) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) C12-15 ALKYL LACTATE (UNII: GC844VRD7E) TRIMETHYLOLPROPANE TRIISOSTEARATE (UNII: Y32A6D7C6L) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) PHENOXYETHANOL (UNII: HIE492ZZ3T) TOCOPHEROL (UNII: R0ZB2556P8) D&C RED NO. 30 (UNII: 2S42T2808B) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color pink (Stoked) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61601-0081-2 1 in 1 CARTON 1 3.5 g in 1 APPLICATOR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 06/05/2014 Labeler - Space Brands Limited (218214381)
