LIPSTICK QUEEN ENDLESS SUMMER BROAD SPECTRUM SPF 15 SUNSCREEN- homosalate, octinoxate, avobenzone and octocrylene lipstick 
Space Brands Limited

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.

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LIPSTICK QUEEN ENDLESS SUMMER Broad Spectrum SPF 15 Sunscreen

Drug Facts

Active Ingredients                    Purpose

Homosalate 10%                    Sunscreen

Octinoxate 4%                       Sunscreen

Avobenzone 3%                     Sunscreen

Octocrylene 2%                     Sunscreen

Uses

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

- limit time in the sun, especially from 10 a.m. - 2 p.m.

- wear long-sleeve shirts, pants, hats, and sunglasses

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).

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).

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).

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 - Aloha

DRUG FACTS PANEL - Carton - Aloha

DRUG FACTS PANEL - Carton - Aloha

PRINCIPAL DISPLAY PANEL - Carton - Hang Ten

PRINCIPAL DISPLAY PANEL - Carton - Hang Ten

DRUG FACTS PANEL - Carton - Hang Ten

DRUG FACTS PANEL - Carton - Hang Ten

PRINCIPAL DISPLAY PANEL - Carton - Perfect Wave

PRINCIPAL DISPLAY PANEL - Carton - Perfect Wave

DRUG FACTS PANEL - Carton - Perfect Wave

DRUG FACTS PANEL - Carton - Perfect Wave

PRINCIPAL DISPLAY PANEL - Carton - Stoked

PRINCIPAL DISPLAY PANEL - Carton - Stoked

DRUG FACTS PANEL - Carton - Stoked

DRUG FACTS PANEL - Carton - Stoked

LIPSTICK QUEEN ENDLESS SUMMER BROAD SPECTRUM SPF 15 SUNSCREEN 
homosalate, octinoxate, avobenzone and octocrylene lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61601-0079
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE0.35 g  in 3.5 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.14 g  in 3.5 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.105 g  in 3.5 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE0.07 g  in 3.5 g
Inactive Ingredients
Ingredient NameStrength
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
Colorred (Aloha) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61601-0079-41 in 1 CARTON
13.5 g in 1 APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/05/2014
LIPSTICK QUEEN ENDLESS SUMMER BROAD SPECTRUM SPF 15 SUNSCREEN 
homosalate, octinoxate, avobenzone and octocrylene lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61601-0082
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE0.35 g  in 3.5 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.14 g  in 3.5 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.105 g  in 3.5 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE0.07 g  in 3.5 g
Inactive Ingredients
Ingredient NameStrength
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
Colorbrown (Hang Ten) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61601-0082-31 in 1 CARTON
13.5 g in 1 APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/05/2014
LIPSTICK QUEEN ENDLESS SUMMER BROAD SPECTRUM SPF 15 SUNSCREEN 
homosalate, octinoxate, avobenzone and octocrylene lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61601-0080
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE0.35 g  in 3.5 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.14 g  in 3.5 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.105 g  in 3.5 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE0.07 g  in 3.5 g
Inactive Ingredients
Ingredient NameStrength
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
Colorpink (Perfect Wave) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61601-0080-11 in 1 CARTON
13.5 g in 1 APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/05/2014
LIPSTICK QUEEN ENDLESS SUMMER BROAD SPECTRUM SPF 15 SUNSCREEN 
homosalate, octinoxate, avobenzone and octocrylene lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61601-0081
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE0.35 g  in 3.5 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.14 g  in 3.5 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.105 g  in 3.5 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE0.07 g  in 3.5 g
Inactive Ingredients
Ingredient NameStrength
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
Colorpink (Stoked) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61601-0081-21 in 1 CARTON
13.5 g in 1 APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/05/2014
Labeler - Space Brands Limited (218214381)

Revised: 6/2014
Document Id: 0b9892bb-a399-4596-8598-3a847ff185d1
Set id: b87c3cab-678b-4408-8987-e95c7720bcd5
Version: 1
Effective Time: 20140605
 
Space Brands Limited