Drug Facts

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

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 - Crystal

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 - Bare

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 - Blush

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 - Ruby

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 - Shimmer

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 - Spice

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

PRINCIPAL DISPLAY PANEL - 4.2 G Applicator Carton - Dream

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	07/01/2023

Labeler - MDSolarSciences (013647301)

Hydrating Sheer Lip Balm SPF 30 Broad Spectrum SPF 30 UVA-UVB Sunscreen

Uses

Warnings

Directions

Other Information

Inactive Ingredients

PRINCIPAL DISPLAY PANEL - 4.2 G Applicator Carton - Crystal

PRINCIPAL DISPLAY PANEL - 4.2 G Applicator Carton - Bare

PRINCIPAL DISPLAY PANEL - 4.2 G Applicator Carton - Blush

PRINCIPAL DISPLAY PANEL - 4.2 G Applicator Carton - Ruby

PRINCIPAL DISPLAY PANEL - 4.2 G Applicator Carton - Shimmer

PRINCIPAL DISPLAY PANEL - 4.2 G Applicator Carton - Spice

PRINCIPAL DISPLAY PANEL - 4.2 G Applicator Carton - Dream

Hydrating Sheer Lip Balm SPF 30
Broad Spectrum SPF 30 UVA-UVB Sunscreen