HYDRATING SHEER LIP BALM SPF 30 -CRYSTAL BROAD SPECTRUM SPF 30 UVA-UVB SUNSCREEN- avobenzone, octisalate, and homosalate lipstick HYDRATING SHEER LIP BALM SPF 30 - BARE BROAD SPECTRUM SPF 30 UVA-UVB SUNSCREEN- avobenzone, octisalate, and homosalate lipstick HYDRATING SHEER LIP BALM SPF 30 - BLUSH BROAD SPECTRUM SPF 30 UVA-UVB SUNSCREEN- avobenzone, octisalate, and homosalate lipstick HYDRATING SHEER LIP BALM SPF 30 - RUBY BROAD SPECTRUM SPF 30 UVA-UVB SUNSCREEN- avobenzone, octisalate, and homosalate lipstick HYDRATING SHEER LIP BALM SPF 30 - SHIMMER BROAD SPECTRUM SPF 30 UVA-UVB SUNSCREEN- avobenzone, octisalate, and homosalate lipstick HYDRATING SHEER LIP BALM SPF 30 - SPICE BROAD SPECTRUM SPF 30 UVA-UVB SUNSCREEN- avobenzone, octisalate, and homosalate lipstick HYDRATING SHEER LIP BALM SPF 30 - DREAM BROAD SPECTRUM SPF 30 UVA-UVB SUNSCREEN- avobenzone, octisalate, and homosalate lipstick

Hydrating Sheer Lip Balm SPF 30 - DREAM by

Drug Labeling and Warnings

Hydrating Sheer Lip Balm SPF 30 - DREAM 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, Squalene, 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, May contain: CI 77891, CI 77491, CI 77492, CI 77499, CI 15850, CI 42090, CI 77861, CI 45410, CI 19140

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY
MDSOLARSCIENCES CORP.
GREENS FARMS, CT 06838

PRINCIPAL DISPLAY PANEL - 4.2 G Applicator Carton - Crystal

MDSOLARSCIENCES®

HYDRATING
SHEER
LIP BALM

Broad Spectrum SPF 30

SPF 30

CRYSTAL

DERMATOLOGIST
DEVELOPED

SHEA
BUTTER
VITAMIN E

AVOCADO
OIL
VITAMIN C

.15 OZ / 4.2 G

PRINCIPAL DISPLAY PANEL - 4.2 G Applicator Carton - Bare

MDSOLARSCIENCES®

PROTECT & NOURISH

HYDRATING
SHEER
LIP BALM

Broad Spectrum SPF 30

SPF 30

BARE

SHEA
BUTTER
VITAMIN E

AVOCADO
OIL
VITAMIN C

.15 OZ / 4.2 G

PRINCIPAL DISPLAY PANEL - 4.2 G Applicator Carton - Blush

MDSOLARSCIENCES®

PROTECT & NOURISH

HYDRATING
SHEER
LIP BALM

Broad Spectrum SPF 30

SPF 30

BLUSH

SHEA
BUTTER
VITAMIN E

AVOCADO
OIL
VITAMIN C

.15 OZ / 4.2 G

PRINCIPAL DISPLAY PANEL - 4.2 G Applicator Carton - Ruby

MDSOLARSCIENCES®

PROTECT & NOURISH

HYDRATING
SHEER
LIP BALM

Broad Spectrum SPF 30

SPF 30

RUBY

SHEA
BUTTER
VITAMIN E

AVOCADO
OIL
VITAMIN C

.15 OZ / 4.2 G

PRINCIPAL DISPLAY PANEL - 4.2 G Applicator Carton - Shimmer

MDSOLARSCIENCES®

PROTECT & NOURISH

HYDRATING
SHEER
LIP BALM

Broad Spectrum SPF 30

SPF 30

SHIMMER

SHEA
BUTTER
VITAMIN E

AVOCADO
OIL
VITAMIN C

.15 OZ / 4.2 G

PRINCIPAL DISPLAY PANEL - 4.2 G Applicator Carton - Spice

MDSOLARSCIENCES®

PROTECT & NOURISH

HYDRATING
SHEER
LIP BALM

Broad Spectrum SPF 30

SPF 30

SPICE

SHEA
BUTTER
VITAMIN E

AVOCADO
OIL
VITAMIN C

.15 OZ / 4.2 G

PRINCIPAL DISPLAY PANEL - 4.2 G Applicator Carton - Dream

MDSOLARSCIENCES®

PROTECT & NOURISH

HYDRATING
SHEER
LIP BALM

Broad Spectrum SPF 30

SPF 30

DREAM

SHEA
BUTTER
VITAMIN E

AVOCADO
OIL
VITAMIN C

.15 OZ / 4.2 G

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49358-600
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)
HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)
Paraffin (UNII: I9O0E3H2ZE)
OCTYLDODECANOL (UNII: 461N1O614Y)
CASTOR OIL (UNII: D5340Y2I9G)
OLIVE OIL (UNII: 6UYK2W1W1E)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CORN OIL (UNII: 8470G57WFM)
HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)
STEARIC ACID (UNII: 4ELV7Z65AP)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
SQUALANE (UNII: GW89575KF9)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)
ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49358-600-01	1 in 1 CARTON	07/01/2023
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 FINAL	part352	07/01/2023

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49358-601
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)
HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)
Paraffin (UNII: I9O0E3H2ZE)
CASTOR OIL (UNII: D5340Y2I9G)
OLIVE OIL (UNII: 6UYK2W1W1E)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CORN OIL (UNII: 8470G57WFM)
HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
STEARIC ACID (UNII: 4ELV7Z65AP)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
SQUALANE (UNII: GW89575KF9)
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)
ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
May contain	TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
May contain	FERRIC OXIDE RED (UNII: 1K09F3G675)
May contain	FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
May contain	FERROSOFERRIC OXIDE (UNII: XM0M87F357)
May contain	D&C RED NO. 6 (UNII: 481744AI4O)
May contain	FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
May contain	STANNIC OXIDE (UNII: KM7N50LOS6)
May contain	D&C RED NO. 28 (UNII: 767IP0Y5NH)
May contain	FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Product Characteristics
Color	BROWN	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49358-601-01	1 in 1 CARTON	07/01/2023
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 FINAL	part352	07/01/2023

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49358-602
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)
HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)
Paraffin (UNII: I9O0E3H2ZE)
CASTOR OIL (UNII: D5340Y2I9G)
OLIVE OIL (UNII: 6UYK2W1W1E)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CORN OIL (UNII: 8470G57WFM)
HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
STEARIC ACID (UNII: 4ELV7Z65AP)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
SQUALANE (UNII: GW89575KF9)
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)
ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
May contain	TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
May contain	FERRIC OXIDE RED (UNII: 1K09F3G675)
May contain	FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
May contain	FERROSOFERRIC OXIDE (UNII: XM0M87F357)
May contain	D&C RED NO. 6 (UNII: 481744AI4O)
May contain	FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
May contain	STANNIC OXIDE (UNII: KM7N50LOS6)
May contain	D&C RED NO. 28 (UNII: 767IP0Y5NH)
May contain	FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Product Characteristics
Color	PINK	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49358-602-01	1 in 1 CARTON	07/01/2023
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 FINAL	part352	07/01/2023

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49358-603
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)
HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)
Paraffin (UNII: I9O0E3H2ZE)
CASTOR OIL (UNII: D5340Y2I9G)
OLIVE OIL (UNII: 6UYK2W1W1E)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CORN OIL (UNII: 8470G57WFM)
HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
STEARIC ACID (UNII: 4ELV7Z65AP)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
SQUALANE (UNII: GW89575KF9)
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)
ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
May contain	TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
May contain	FERRIC OXIDE RED (UNII: 1K09F3G675)
May contain	FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
May contain	FERROSOFERRIC OXIDE (UNII: XM0M87F357)
May contain	D&C RED NO. 6 (UNII: 481744AI4O)
May contain	FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
May contain	STANNIC OXIDE (UNII: KM7N50LOS6)
May contain	D&C RED NO. 28 (UNII: 767IP0Y5NH)
May contain	FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Product Characteristics
Color	RED	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49358-603-01	1 in 1 CARTON	07/01/2023
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 FINAL	part352	07/01/2023

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49358-604
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)
HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)
Paraffin (UNII: I9O0E3H2ZE)
CASTOR OIL (UNII: D5340Y2I9G)
OLIVE OIL (UNII: 6UYK2W1W1E)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CORN OIL (UNII: 8470G57WFM)
HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
STEARIC ACID (UNII: 4ELV7Z65AP)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
SQUALANE (UNII: GW89575KF9)
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)
ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
May contain	TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
May contain	FERRIC OXIDE RED (UNII: 1K09F3G675)
May contain	FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
May contain	FERROSOFERRIC OXIDE (UNII: XM0M87F357)
May contain	D&C RED NO. 6 (UNII: 481744AI4O)
May contain	FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
May contain	STANNIC OXIDE (UNII: KM7N50LOS6)
May contain	D&C RED NO. 28 (UNII: 767IP0Y5NH)
May contain	FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Product Characteristics
Color	PINK	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49358-604-01	1 in 1 CARTON	07/01/2023
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 FINAL	part352	07/01/2023

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49358-605
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)
HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)
Paraffin (UNII: I9O0E3H2ZE)
CASTOR OIL (UNII: D5340Y2I9G)
OLIVE OIL (UNII: 6UYK2W1W1E)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CORN OIL (UNII: 8470G57WFM)
HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
STEARIC ACID (UNII: 4ELV7Z65AP)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
SQUALANE (UNII: GW89575KF9)
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TOCOPHEROL (UNII: R0ZB2556P8)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)
ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
May contain	TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
May contain	FERRIC OXIDE RED (UNII: 1K09F3G675)
May contain	FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
May contain	FERROSOFERRIC OXIDE (UNII: XM0M87F357)
May contain	D&C RED NO. 6 (UNII: 481744AI4O)
May contain	FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
May contain	STANNIC OXIDE (UNII: KM7N50LOS6)
May contain	D&C RED NO. 28 (UNII: 767IP0Y5NH)
May contain	FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Product Characteristics
Color	RED	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49358-605-01	1 in 1 CARTON	07/01/2023
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 FINAL	part352	07/01/2023

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49358-606
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)
HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)
Paraffin (UNII: I9O0E3H2ZE)
CASTOR OIL (UNII: D5340Y2I9G)
OLIVE OIL (UNII: 6UYK2W1W1E)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CORN OIL (UNII: 8470G57WFM)
HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
STEARIC ACID (UNII: 4ELV7Z65AP)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
SQUALANE (UNII: GW89575KF9)
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TOCOPHEROL (UNII: R0ZB2556P8)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)
ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
May contain	TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
May contain	FERRIC OXIDE RED (UNII: 1K09F3G675)
May contain	FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
May contain	FERROSOFERRIC OXIDE (UNII: XM0M87F357)
May contain	D&C RED NO. 6 (UNII: 481744AI4O)
May contain	FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
May contain	STANNIC OXIDE (UNII: KM7N50LOS6)
May contain	D&C RED NO. 28 (UNII: 767IP0Y5NH)
May contain	FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Product Characteristics
Color	PINK	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49358-606-01	1 in 1 CARTON	07/01/2023
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 FINAL	part352	07/01/2023

Labeler - MDSolarSciences (013647301)