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

LIPSTICK QUEEN ENDLESS SUMMER Broad Spectrum SPF 15 Sunscreen by

Drug Labeling and Warnings

LIPSTICK QUEEN ENDLESS SUMMER Broad Spectrum SPF 15 Sunscreen by is a Otc medication manufactured, distributed, or labeled by Space Brands Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients                    Purpose

Homosalate 10%                    Sunscreen

Octinoxate 4%                       Sunscreen

Avobenzone 3%                     Sunscreen

Octocrylene 2%                     Sunscreen

Uses

• helps prevent sunburn
• if used as directed with other sunburn protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only.

DO NOT USE

Do not use on damaged or broken skin.

WHEN USING

When using this product keep out of eyes. Rinse with water to remove.

STOP USE

Stop use and ask a doctor if rash occurs.

KEEP OUT OF REACH OF CHILDREN

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 (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

• protect this product from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL - Carton - Aloha

DRUG FACTS PANEL - Carton - Aloha

PRINCIPAL DISPLAY PANEL - Carton - Hang Ten

DRUG FACTS PANEL - Carton - Hang Ten

PRINCIPAL DISPLAY PANEL - Carton - Perfect Wave

DRUG FACTS PANEL - Carton - Perfect Wave

PRINCIPAL DISPLAY PANEL - Carton - Stoked

DRUG FACTS PANEL - Carton - Stoked

INGREDIENTS AND APPEARANCE

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

Product 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 lipstick

Product 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 lipstick

Product 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 lipstick

Product 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)