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)

PINK Label CORAL Label BERRY Label Tube Label Outer Package

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

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

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

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

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

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

Labeler - LAURA GELLER MAKE UP INC. (199474524)

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