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 
MDSolarSciences

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

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

Drug Facts

Active ingredientsPurpose
Avobenzone 3%Sunscreen
Octisalate 5%Sunscreen
Homosalate 10%Sunscreen

Uses

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

Other Information

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:49358-600
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone30 mg  in 1 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate50 mg  in 1 g
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate100 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49358-600-011 in 1 CARTON07/01/2023
14.2 g in 1 APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35207/01/2023
HYDRATING SHEER LIP BALM SPF 30 - BARE   BROAD SPECTRUM SPF 30 UVA-UVB SUNSCREEN
avobenzone, octisalate, and homosalate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49358-601
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone30 mg  in 1 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate50 mg  in 1 g
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate100 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 KindIngredient NameQuantity
May containTITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
May containFERRIC OXIDE RED (UNII: 1K09F3G675)  
May containFERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
May containFERROSOFERRIC OXIDE (UNII: XM0M87F357)  
May containD&C RED NO. 6 (UNII: 481744AI4O)  
May containFD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
May containSTANNIC OXIDE (UNII: KM7N50LOS6)  
May containD&C RED NO. 28 (UNII: 767IP0Y5NH)  
May containFD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Product Characteristics
ColorBROWNScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49358-601-011 in 1 CARTON07/01/2023
14.2 g in 1 APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35207/01/2023
HYDRATING SHEER LIP BALM SPF 30 - BLUSH   BROAD SPECTRUM SPF 30 UVA-UVB SUNSCREEN
avobenzone, octisalate, and homosalate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49358-602
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone30 mg  in 1 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate50 mg  in 1 g
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate100 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 KindIngredient NameQuantity
May containTITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
May containFERRIC OXIDE RED (UNII: 1K09F3G675)  
May containFERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
May containFERROSOFERRIC OXIDE (UNII: XM0M87F357)  
May containD&C RED NO. 6 (UNII: 481744AI4O)  
May containFD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
May containSTANNIC OXIDE (UNII: KM7N50LOS6)  
May containD&C RED NO. 28 (UNII: 767IP0Y5NH)  
May containFD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Product Characteristics
ColorPINKScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49358-602-011 in 1 CARTON07/01/2023
14.2 g in 1 APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35207/01/2023
HYDRATING SHEER LIP BALM SPF 30 - RUBY   BROAD SPECTRUM SPF 30 UVA-UVB SUNSCREEN
avobenzone, octisalate, and homosalate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49358-603
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone30 mg  in 1 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate50 mg  in 1 g
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate100 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 KindIngredient NameQuantity
May containTITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
May containFERRIC OXIDE RED (UNII: 1K09F3G675)  
May containFERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
May containFERROSOFERRIC OXIDE (UNII: XM0M87F357)  
May containD&C RED NO. 6 (UNII: 481744AI4O)  
May containFD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
May containSTANNIC OXIDE (UNII: KM7N50LOS6)  
May containD&C RED NO. 28 (UNII: 767IP0Y5NH)  
May containFD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Product Characteristics
ColorREDScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49358-603-011 in 1 CARTON07/01/2023
14.2 g in 1 APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35207/01/2023
HYDRATING SHEER LIP BALM SPF 30 - SHIMMER   BROAD SPECTRUM SPF 30 UVA-UVB SUNSCREEN
avobenzone, octisalate, and homosalate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49358-604
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone30 mg  in 1 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate50 mg  in 1 g
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate100 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 KindIngredient NameQuantity
May containTITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
May containFERRIC OXIDE RED (UNII: 1K09F3G675)  
May containFERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
May containFERROSOFERRIC OXIDE (UNII: XM0M87F357)  
May containD&C RED NO. 6 (UNII: 481744AI4O)  
May containFD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
May containSTANNIC OXIDE (UNII: KM7N50LOS6)  
May containD&C RED NO. 28 (UNII: 767IP0Y5NH)  
May containFD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Product Characteristics
ColorPINKScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49358-604-011 in 1 CARTON07/01/2023
14.2 g in 1 APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35207/01/2023
HYDRATING SHEER LIP BALM SPF 30 - SPICE   BROAD SPECTRUM SPF 30 UVA-UVB SUNSCREEN
avobenzone, octisalate, and homosalate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49358-605
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone30 mg  in 1 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate50 mg  in 1 g
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate100 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 KindIngredient NameQuantity
May containTITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
May containFERRIC OXIDE RED (UNII: 1K09F3G675)  
May containFERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
May containFERROSOFERRIC OXIDE (UNII: XM0M87F357)  
May containD&C RED NO. 6 (UNII: 481744AI4O)  
May containFD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
May containSTANNIC OXIDE (UNII: KM7N50LOS6)  
May containD&C RED NO. 28 (UNII: 767IP0Y5NH)  
May containFD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Product Characteristics
ColorREDScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49358-605-011 in 1 CARTON07/01/2023
14.2 g in 1 APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35207/01/2023
HYDRATING SHEER LIP BALM SPF 30 - DREAM   BROAD SPECTRUM SPF 30 UVA-UVB SUNSCREEN
avobenzone, octisalate, and homosalate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49358-606
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone30 mg  in 1 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate50 mg  in 1 g
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate100 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 KindIngredient NameQuantity
May containTITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
May containFERRIC OXIDE RED (UNII: 1K09F3G675)  
May containFERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
May containFERROSOFERRIC OXIDE (UNII: XM0M87F357)  
May containD&C RED NO. 6 (UNII: 481744AI4O)  
May containFD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
May containSTANNIC OXIDE (UNII: KM7N50LOS6)  
May containD&C RED NO. 28 (UNII: 767IP0Y5NH)  
May containFD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Product Characteristics
ColorPINKScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49358-606-011 in 1 CARTON07/01/2023
14.2 g in 1 APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35207/01/2023
Labeler - MDSolarSciences (013647301)

Revised: 9/2023
Document Id: 9883f7bb-a679-4f29-b3f7-32ef5c0fee0d
Set id: 0f23441c-2399-4a72-9f0a-420d25db78af
Version: 1
Effective Time: 20230920
 
MDSolarSciences