HYDRATING SHEER LIP BALM SPF 30 - TRIO- avobenzone, octisalate, and homosalate kit

Hydrating Sheer Lip Balm SPF 30 - TRIO by

Drug Labeling and Warnings

Hydrating Sheer Lip Balm SPF 30 - TRIO by is a Otc medication manufactured, distributed, or labeled by MDSolarSciences. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
Avobenzone 2%	Sunscreen
Octisalate 5%	Sunscreen
Homosalate 10%	Sunscreen

Uses

• Helps prevent sunburn
• If used as directed with other sun 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 on damaged or broken skin. Stop use and ask a doctor if rash occurs. When using this product keep out of eyes. Rinse with water to remove.

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 & again after swimming or sweating.
• Reapply at least every 2 hours.
• Children under 6 months: Ask a doctor
• Sun Protection Measures: To decrease your risk of skin cancer and early skin aging, regularly use a sunscreen of SPF15 or higher and other sun protective measures including:
• Limit time in the sun, especially from 10a.m.-2p.m.
• Wear long-sleeved shirts, pants, hats and sunglasses

Other Information

• Protect the product in this container from excessive heat and direct sunlight
• You may report serious adverse reactions to: Report Reaction, LLC. PO Box 22, Plainsboro, NJ 08536-0222

Inactive Ingredients

Persea Gratissima (Avocado) Oil, Butyrospermum Parkii (Shea) Butter, Paraffin Wax, Hydrogenated Soybean Oil, Ricinus Communis (Castor) Seed Oil, Octyldodecanol, Olea Europaea (Olive) Fruit Oil, Jojoba Esters, Hydrogenated Vegetable Oil, Microcrystalline Wax, Stearic Acid, Helianthus Annuus (Sunflower) Seed Oil, Squalane, Acacia Decurrens Flower Wax, Polyglycerin-3, Rhus Verniciflua Peel Wax, Sorbitan Oleate, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Ascorbyl Palmitate, Tocopherol. May contain: Titanium Dioxide (CI 77891), Iron Oxides (CI 77491- Red), Iron Oxides (CI 77492 - Yellow), Iron Oxides (CI 77499 - Black) CI 19140 - Yellow 5, Red 28 Lake (CI 45410)

SPL UNCLASSIFIED SECTION

Distributed by: MDSolarSciences Corp, Stamford, CT 06902

PRINCIPAL DISPLAY PANEL - Kit Carton

MDSolarSciences™

30
HYDRATING
SHEER
LIP BALM
TRIO

BROAD SP ECTRUM SPF 30 UVA- UVB SUNSCRE EN

Net Wt. 4.2 g -.15Oz

INGREDIENTS AND APPEARANCE

HYDRATING SHEER LIP BALM SPF 30 - TRIO 
avobenzone, octisalate, and homosalate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49358-567

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49358-567-01	1 in 1 CARTON	10/01/2019

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 APPLICATOR	4.2 g
Part 2	1 APPLICATOR	4.2 g
Part 3	1 APPLICATOR	4.2 g

Part 1 of 3

HYDRATING SHEER LIP BALM SPF 30 - RED   BROAD SPECTRUM SPF 30 UVA-UVB SUNSCREEN
avobenzone, octisalate, and homosalate lipstick

Product Information
Item Code (Source)	NDC: 49358-564
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	30 mg  in 1 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	50 mg  in 1 g
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Avocado Oil (UNII: 6VNO72PFC1)
Shea Butter (UNII: K49155WL9Y)
PARAFFIN (UNII: I9O0E3H2ZE)
HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)
Castor Oil (UNII: D5340Y2I9G)
OCTYLDODECANOL (UNII: 461N1O614Y)
OLIVE OIL (UNII: 6UYK2W1W1E)
HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)
CORN OIL (UNII: 8470G57WFM)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUNFLOWER OIL (UNII: 3W1JG795YI)
SQUALANE (UNII: GW89575KF9)
ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)
TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
TOCOPHEROL (UNII: R0ZB2556P8)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 28 (UNII: 767IP0Y5NH)

Product Characteristics
Color	RED	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49358-564-01	4.2 g in 1 APPLICATOR; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	10/01/2019

Part 2 of 3

HYDRATING SHEER LIP BALM SPF 30 - PINK  BROAD SPECTRUM SPF 30 UVA-UVB SUNSCREEN
avobenzone, octisalate, and homosalate lipstick

Product Information
Item Code (Source)	NDC: 49358-565
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	30 mg  in 1 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	50 mg  in 1 g
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Avocado Oil (UNII: 6VNO72PFC1)
Shea Butter (UNII: K49155WL9Y)
PARAFFIN (UNII: I9O0E3H2ZE)
HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)
Castor Oil (UNII: D5340Y2I9G)
OCTYLDODECANOL (UNII: 461N1O614Y)
OLIVE OIL (UNII: 6UYK2W1W1E)
HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)
CORN OIL (UNII: 8470G57WFM)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUNFLOWER OIL (UNII: 3W1JG795YI)
SQUALANE (UNII: GW89575KF9)
ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)
TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
TOCOPHEROL (UNII: R0ZB2556P8)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 28 (UNII: 767IP0Y5NH)

Product Characteristics
Color	PINK	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49358-565-01	4.2 g in 1 APPLICATOR; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	10/01/2019

Part 3 of 3

HYDRATING SHEER LIP BALM SPF 30 - NUDE   BROAD SPECTRUM SPF 30 UVA-UVB SUNSCREEN
avobenzone, octisalate, and homosalate lipstick

Product Information
Item Code (Source)	NDC: 49358-566
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	30 mg  in 1 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	50 mg  in 1 g
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Avocado Oil (UNII: 6VNO72PFC1)
Shea Butter (UNII: K49155WL9Y)
PARAFFIN (UNII: I9O0E3H2ZE)
HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)
Castor Oil (UNII: D5340Y2I9G)
OCTYLDODECANOL (UNII: 461N1O614Y)
OLIVE OIL (UNII: 6UYK2W1W1E)
HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)
CORN OIL (UNII: 8470G57WFM)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUNFLOWER OIL (UNII: 3W1JG795YI)
SQUALANE (UNII: GW89575KF9)
ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)
TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
TOCOPHEROL (UNII: R0ZB2556P8)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 28 (UNII: 767IP0Y5NH)

Product Characteristics
Color	BROWN	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49358-566-01	4.2 g in 1 APPLICATOR; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	10/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	10/01/2019

Labeler - MDSolarSciences (013647301)