HYDRATING SHEER LIP BALM TRIO THE VIVIDS BROAD SPECTRUM SPF 30- avobenzone, octisalate, and homosalate kit

Hydrating Sheer Lip Balm Trio The Vivids by

Drug Labeling and Warnings

Hydrating Sheer Lip Balm Trio The Vivids 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 3%	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

• 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
• Reapply:
  • use a water resistant sunscreen if swimming or sweating
  • at least every 2 hours
• Children under 6 months: Ask a doctor
• Sun Protection Measures :Spending time in the sun increases your risk of skin cancer and early skin aging.
  To decrease the risk, regularly use a sunscreen with Broad Spectrum SPF of 15 or higher and other sun protection 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, Hydrogenated Soybean Oil, Paraffin, Ricinus Communis (Castor) Seed Oil, Olea Europaea (Olive) Fruit Oil, Octyldodecanol, Butyloctyl Salicylate, Hydrogenated Vegetable Oil, Jojoba Esters, Microcrystalline Wax, Stearic Acid, Helianthus Annuus (Sunflower) Seed Wax, Plant-Derived Squalane, Polyglycerin-3, Tetrahexyldecyl Ascorbate (Vitamin C), Tocopheryl Acetate (Vitamin E), Ascorbyl Palmitate (Vitamin C), Tocopherol (Vitamin E), Rhus Verniciflua Peel Wax, Acacia Decurrens Flower Wax, Sorbitan Oleate, Synthetic Fluorphlogopite (Dream/Spice), May contain: CI 77891, CI 77491, CI 77492, CI 77499, CI 15850, CI 42090, CI 77861, CI 45410, CI 19140

Company Information

DISTRIBUTED BY
MDSOLARSCIENCES CORP.
GREENS FARMS, CT 06838

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HYDRATING SHEER LIP BALM TRIO THE VIVIDS  BROAD SPECTRUM SPF 30
avobenzone, octisalate, and homosalate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49358-006

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49358-006-01	1 in 1 CARTON; Type 0: Not a Combination Product	06/10/2025

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  RUBY BROAD SPECTRUM SPF 30
avobenzone, octisalate, homosalate lipstick

Product Information
Item Code (Source)	NDC: 49358-007
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CI 77491 (UNII: 1K09F3G675)
CI 77492 (UNII: EX438O2MRT)
CI 42090 (UNII: H3R47K3TBD)
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)
SHEA BUTTER (UNII: K49155WL9Y)
SORBITAN OLEATE (UNII: 06XEA2VD56)
CI 19140 (UNII: I753WB2F1M)
OCTYLDODECANOL (UNII: 461N1O614Y)
CI 77499 (UNII: XM0M87F357)
CI 15850 (UNII: 481744AI4O)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
PARAFFIN (UNII: I9O0E3H2ZE)
CI 77891 (UNII: 15FIX9V2JP)
AVOCADO OIL (UNII: 6VNO72PFC1)
CASTOR OIL (UNII: D5340Y2I9G)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
STEARIC ACID (UNII: 4ELV7Z65AP)
HELIANTHUS ANNUUS (SUNFLOWER) SEED WAX (UNII: 42DG15CHXV)
RHUS VERNICIFLUA PEEL WAX (UNII: 6RG2461FCH)
OLIVE OIL (UNII: 6UYK2W1W1E)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
CI 45410 (UNII: 767IP0Y5NH)
SQUALANE (UNII: GW89575KF9)
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)
TOCOPHEROL (UNII: R0ZB2556P8)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)
ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		4.2 g in 1 APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	06/10/2025

Part 2 of 3

HYDRATING SHEER LIP BALM SPF 30  BLUSH BROAD SPECTRUM SPF 30
avobenzone, octisalate, homosalate lipstick

Product Information
Item Code (Source)	NDC: 49358-008
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CI 77491 (UNII: 1K09F3G675)
CI 77492 (UNII: EX438O2MRT)
CI 42090 (UNII: H3R47K3TBD)
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)
SHEA BUTTER (UNII: K49155WL9Y)
CI 19140 (UNII: I753WB2F1M)
OCTYLDODECANOL (UNII: 461N1O614Y)
CI 77499 (UNII: XM0M87F357)
CI 15850 (UNII: 481744AI4O)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
CI 77891 (UNII: 15FIX9V2JP)
AVOCADO OIL (UNII: 6VNO72PFC1)
CASTOR OIL (UNII: D5340Y2I9G)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
STEARIC ACID (UNII: 4ELV7Z65AP)
HELIANTHUS ANNUUS (SUNFLOWER) SEED WAX (UNII: 42DG15CHXV)
RHUS VERNICIFLUA PEEL WAX (UNII: 6RG2461FCH)
OLIVE OIL (UNII: 6UYK2W1W1E)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
CI 45410 (UNII: 767IP0Y5NH)
SQUALANE (UNII: GW89575KF9)
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)
TOCOPHEROL (UNII: R0ZB2556P8)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)
ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)
SORBITAN OLEATE (UNII: 06XEA2VD56)
PARAFFIN (UNII: I9O0E3H2ZE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		4.2 g in 1 APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	06/10/2025

Part 3 of 3

HYDRATING SHEER LIP BALM SPF 30  SPICE BROAD SPECTRUM SPF 30
avobenzone, octisalate, homosalate lipstick

Product Information
Item Code (Source)	NDC: 49358-009
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CI 77491 (UNII: 1K09F3G675)
CI 77492 (UNII: EX438O2MRT)
CI 42090 (UNII: H3R47K3TBD)
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)
SHEA BUTTER (UNII: K49155WL9Y)
CI 19140 (UNII: I753WB2F1M)
OCTYLDODECANOL (UNII: 461N1O614Y)
CI 77499 (UNII: XM0M87F357)
CI 15850 (UNII: 481744AI4O)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
CI 77891 (UNII: 15FIX9V2JP)
AVOCADO OIL (UNII: 6VNO72PFC1)
CASTOR OIL (UNII: D5340Y2I9G)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
STEARIC ACID (UNII: 4ELV7Z65AP)
HELIANTHUS ANNUUS (SUNFLOWER) SEED WAX (UNII: 42DG15CHXV)
RHUS VERNICIFLUA PEEL WAX (UNII: 6RG2461FCH)
OLIVE OIL (UNII: 6UYK2W1W1E)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
CI 45410 (UNII: 767IP0Y5NH)
SQUALANE (UNII: GW89575KF9)
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)
TOCOPHEROL (UNII: R0ZB2556P8)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)
ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)
SORBITAN OLEATE (UNII: 06XEA2VD56)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
PARAFFIN (UNII: I9O0E3H2ZE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		4.2 g in 1 APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	06/10/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	06/10/2025

Labeler - MDSolarSciences (013647301)