LAURA GELLER BEAUTY SUN KISSED COLOR LIP BALM TRIO BROAD SPECTRUM SPF 15 PINK - CORAL - BERRY- octisalate, avobenzone, octinoxate, octocrylene kit

LAURA GELLER BEAUTY SUN KISSED COLOR LIP BALM TRIO BROAD SPECTRUM SPF 15 Pink - Coral - Berry by

Drug Labeling and Warnings

LAURA GELLER BEAUTY SUN KISSED COLOR LIP BALM TRIO BROAD SPECTRUM SPF 15 Pink - Coral - Berry by is a Otc medication manufactured, distributed, or labeled by LAURA GELLER MAKE UP INC., Gotha Cosmetics SRL. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

LAURA GELLER BEAUTY SUN KISSED COLOR LIP BALM TRIO BROAD SPECTRUM SPF 15 Pink - Coral - Berry

Active Ingredients

Octisalate 5%
Avobenzone 2.5%
Octinoxate 2%
Octocrylene 1.5%

Purpose

Sunscreen

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 product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Apply liberally 15 minutes before sun exposure.
• Use a water resistant sunscreen if swimming or sweating.
• Reapply at least every 2 hours.
• 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 value 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-sleeved shirts, pants, hats and sunglasses.
• children under 6 months of age: Ask a doctor.
  

Inactive Ingredients

Berry: Caprylic/Capric Triglyceride, C12-15 Alkyl Benzoate, Polyethylene, Pentaerythrityl Tetraisostearate, Mica, Microcrystalline Wax, Helianthus Annuus (Sunflower) Seed Wax, Silica Silylate, Stearalkonium Bentonite, Dicalcium Phosphate, Tocopheryl Acetate, Propylene Carbonate, Ethyl Vanillin, Pentaerythrityl Tetra-Di-T-Butyl Hydroxyhydrocinnamate, 1,2-Hexanediol, Caprylyl Glycol, Mangifera Indica (Mango) Seed Butter, Ethylhexyl Cocoate, Cocos Nucifera (Coconut) Oil. May Contain: Titanium Dioxide, Red 7 Lake, Iron Oxides, Blue 1 Lake Coral, Pink: Caprylic/Capric Triglyceride, C12-15 Alkyl Benzoate, Polyethylene, Pentaerythrityl Tetraisostearate, Mica, Microcrystalline Wax, Helianthus Annuus (Sunflower) Seed Wax, Dicalcium Phosphate, Silica Silylate, Stearalkonium Bentonite,
Tocopheryl Acetate, Propylene Carbonate, Ethyl Vanillin, Pentaerythrityl Tetra-Di-T-Butyl Hydroxyhydrocinnamate, 1,2-Hexanediol, Caprylyl Glycol, Mangifera Indica (Mango) Seed Butter, Ethylhexyl Cocoate, Cocos Nucifera (Coconut) Oil. May Contain: Titanium Dioxide, Red 28 Lake, Red 6

Other Information

• Protect the product in this container from excessive heat and direct sun.
  

Questions or comments?

Call Laura Geller Beauty, LLC, 1 (800) MAKE UP4

LAURA GELLER BEAUTY SUN KISSED COLOR LIP BALM TRIO BROAD SPECTRUM SPF 15 Pink - Coral - Berry (

51389-122-03)

LAURA GELLER Sun Kissed Lip Balm broad spectrum SPF 15 PINK 2.5g (51389-123-01)

LAURA GELLER Sun Kissed Lip Balm broad spectrum SPF 15 CORAL 2.5g (51389-124-01)

LAURA GELLER Sun Kissed Lip Balm broad spectrum SPF 15 BERRY 2.5g (51389-125-01)

INGREDIENTS AND APPEARANCE

LAURA GELLER BEAUTY SUN KISSED COLOR LIP BALM TRIO BROAD SPECTRUM SPF 15 PINK - CORAL - BERRY 
octisalate, avobenzone, octinoxate, octocrylene kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51389-122

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51389-122-03	1 in 1 KIT; Type 1: Convenience Kit of Co-Package	12/09/2013

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	2.5 g
Part 2	1 TUBE	2.5 g
Part 3	1 TUBE	2.5 g

Part 1 of 3

LAURA GELLER SUN KISSED LIP BALM BROAD SPECTRUM SPF 15 PINK 
octisalate, avobenzone, octinoxate, octocrylene lipstick

Product Information
Item Code (Source)	NDC: 51389-123
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.5 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
PENTAERYTHRITYL TETRAISOSTEARATE (UNII: 9D7IK5483F)
MICA (UNII: V8A1AW0880)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
ETHYL VANILLIN (UNII: YC9ST449YJ)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)
ETHYLHEXYL COCOATE (UNII: I1MPW273QS)
COCONUT OIL (UNII: Q9L0O73W7L)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
D&C RED NO. 6 (UNII: 481744AI4O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51389-123-01	1 in 1 PACKAGE
1		2.5 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/06/2013

Part 2 of 3

LAURA GELLER SUN KISSED LIP BALM BROAD SPECTRUM SPF 15 CORAL  
octisalate, avobenzone, octinoxate, octocrylene lipstick

Product Information
Item Code (Source)	NDC: 51389-124
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.5 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
PENTAERYTHRITYL TETRAISOSTEARATE (UNII: 9D7IK5483F)
MICA (UNII: V8A1AW0880)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
ETHYL VANILLIN (UNII: YC9ST449YJ)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)
ETHYLHEXYL COCOATE (UNII: I1MPW273QS)
COCONUT OIL (UNII: Q9L0O73W7L)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
D&C RED NO. 6 (UNII: 481744AI4O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51389-124-01	1 in 1 PACKAGE
1		2.5 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/06/2013

Part 3 of 3

LAURA GELLER SUN KISSED LIP BALM BROAD SPECTRUM SPF 15 BERRY  
octisalate, avobenzone, octinoxate, octocrylene lipstick

Product Information
Item Code (Source)	NDC: 51389-125
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.5 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
PENTAERYTHRITYL TETRAISOSTEARATE (UNII: 9D7IK5483F)
MICA (UNII: V8A1AW0880)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
ETHYL VANILLIN (UNII: YC9ST449YJ)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)
ETHYLHEXYL COCOATE (UNII: I1MPW273QS)
COCONUT OIL (UNII: Q9L0O73W7L)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51389-125-01	1 in 1 PACKAGE
1		2.5 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/06/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/09/2013

Labeler - LAURA GELLER MAKE UP INC. (199474524)

Establishment
Name	Address	ID/FEI	Business Operations
Gotha Cosmetics SRL		378071679	manufacture(51389-125, 51389-124, 51389-123, 51389-122)