NEUTROGENA MOISTURESHINE LIP SOOTHER WITH SUNSCREEN SPF 20, SHINE 30- avobenzone, homosalate, octocrylene gel NEUTROGENA MOISTURESHINE LIP SOOTHER WITH SUNSCREEN SPF 20, GLOW 70- avobenzone, homosalate, octocrylene gel NEUTROGENA MOISTURESHINE LIP SOOTHER WITH SUNSCREEN SPF 20, GLEAM 40- avobenzone, homosalate, octocrylene gel NEUTROGENA MOISTURESHINE LIP SOOTHER WITH SUNSCREEN SPF 20, GLAZE 60- avobenzone, homosalate, octocrylene gel

Neutrogena MoistureShine Lip Soother with Sunscreen SPF 20, Glaze 60 by

Drug Labeling and Warnings

Neutrogena MoistureShine Lip Soother with Sunscreen SPF 20, Glaze 60 by is a Otc medication manufactured, distributed, or labeled by Kenvue Brands LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Avobenzone (3%), Homosalate (10%), Octocrylene (10%)

Purpose

Sunscreen

Use

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

When using this product

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

rash occurs.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away

Directions For Sunscreen Use

apply generously and evenly 15 minutes before sun exposure

reapply at least every 2 hours

use a water resistant sunscreen if swimming or sweating

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

limit time in the sun, especially from 10 a.m. – 2 p.m.

wear long-sleeved shirts, pants, hats, and sunglasses

children under 6 months of age: Ask a doctor

Other Information

protect this product from excessive heat and direct sun

may stain some fabrics

Inactive ingredients

Polybutene, Bis-Diglyceryl Polyacyladipate-2, Glycerin, Octyldodecanol, Synthetic Beeswax, Diisocetyl Dodecanedioate, Ricinus Communis (Castor) Seed Oil, Behenyl Alcohol, Polyglyceryl-3 Stearate, Carthamus Tinctorius (Safflower) Seed Oil, Silica Silylate, Fragrance, Menthol, Spirulina Maxima Extract, Laminaria Saccharina, Extract, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Saccharin, Aloe Barbadensis Leaf Extract, chamomilla recutita (matricaria) flower extract, Cucumis Sativus (Cucumber) Fruit Extract, Ascorbyl Palmitate, Tocopherol, Glycine Soja (Soybean) Oil, Iron Oxides, Red 7 Lake, Blue 1 Lake

Questions?

Call toll free 800-480-4812 or 215-273-8755 (collect) or visit www.neutrogena.com

SPL UNCLASSIFIED SECTION

Distributed by:

JOHNSON & JOHNSON

CONSUMER INC.

Skillman, NJ 08558

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Avobenzone (3%), Homosalate (10%), Octocrylene (10%)

Purpose

Sunscreen

Use

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

When using this product

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

rash occurs.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away

Directions For Sunscreen Use

apply generously and evenly 15 minutes before sun exposure

reapply at least every 2 hours

use a water resistant sunscreen if swimming or sweating

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

limit time in the sun, especially from 10 a.m. – 2 p.m.

wear long-sleeved shirts, pants, hats, and sunglasses

children under 6 months of age: Ask a doctor

Other information

protect this product from excessive heat and direct sun

may stain some fabrics

Inactive ingredients

Polybutene, Bis-Diglyceryl Polyacyladipate-2, Glycerin, Octyldodecanol, Synthetic Beeswax, Diisocetyl Dodecanedioate, Ricinus Communis (Castor) Seed Oil, Behenyl Alcohol, Polyglyceryl-3 Stearate, Carthamus Tinctorius (Safflower) Seed Oil, Silica Silylate, Fragrance, Menthol, Spirulina Maxima Extract, Laminaria Saccharina, Extract, Saccharin, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Aloe Barbadensis Leaf Extract, chamomilla recutita (matricaria) flower extract, Cucumis Sativus (Cucumber) Fruit Extract, Ascorbyl Palmitate, Tocopherol, Glycine Soja (Soybean) Oil, Red 7 Lake, Blue 1 Lake

Questions?

Call toll free 800-480-4812 or 215-273-8755 (collect) or visit www.neutrogena.com

SPL UNCLASSIFIED SECTION

Distributed by:

JOHNSON & JOHNSON

CONSUMER INC.

Skillman, NJ 08558

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Avobenzone (3%), Homosalate (10%), Octocrylene (10%)

Purpose

Sunscreen

Use

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

When using this product

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

rash occurs.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away

Directions For Sunscreen Use

apply generously and evenly 15 minutes before sun exposure

reapply at least every 2 hours

use a water resistant sunscreen if swimming or sweating

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

limit time in the sun, especially from 10 a.m. – 2 p.m.

wear long-sleeved shirts, pants, hats, and sunglasses

children under 6 months of age: Ask a doctor

Other information

protect this product from excessive heat and direct sun

may stain some fabrics

Inactive ingredients

Polybutene, Bis-Diglyceryl Polyacyladipate-2, Glycerin, Octyldodecanol, Synthetic Beeswax, Ricinus Communis (Castor) Seed Oil, Diisocetyl Dodecanedioate, , Behenyl Alcohol, Polyglyceryl-3 Stearate, Carthamus Tinctorius (Safflower) Seed Oil, Silica Silylate, Fragrance, Menthol, Laminaria Saccharina Extract, Spirulina Maxima Extract, , Saccharin , Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, , Aloe Barbadensis Leaf Extract, chamomilla recutita (matricaria) flower extract, Cucumis Sativus (Cucumber) Fruit Extract, Ascorbyl Palmitate, Tocopherol, Glycine Soja (Soybean) Oil, Red 7 Lake, Blue 1 Lake

Questions?

Call toll free 800-480-4812 or 215-273-8755 (collect) or visit www.neutrogena.com

SPL UNCLASSIFIED SECTION

Distributed by:

JOHNSON & JOHNSON

CONSUMER INC.

Skillman, NJ 08558

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Avobenzone (3%), Homosalate (10%), Octocrylene (10%)

Purpose

Sunscreen

Use

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

When using this product

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

rash occurs.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away

Directions For Sunscreen Use

apply generously and evenly 15 minutes before sun exposure

reapply at least every 2 hours

use a water resistant sunscreen if swimming or sweating

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

limit time in the sun, especially from 10 a.m. – 2 p.m.

wear long-sleeved shirts, pants, hats, and sunglasses

children under 6 months of age: Ask a doctor

Other information

protect this product from excessive heat and direct sun

may stain some fabrics

Inactive ingredients

Polybutene, Bis-Diglyceryl Polyacyladipate-2, Glycerin, Octyldodecanol, Synthetic Beeswax, Diisocetyl Dodecanedioate, Ricinus Communis (Castor) Seed Oil, Behenyl Alcohol, Polyglyceryl-3 Stearate, Carthamus Tinctorius (Safflower) Seed Oil, Silica Silylate, Fragrance, Menthol, Laminaria Saccharina Extract, Spirulina Maxima Extract, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Saccharin, Aloe Barbadensis Leaf Extract, chamomilla recutita (matricaria) flower extract, Cucumis Sativus (Cucumber) Fruit Extract, Tin Oxide, Ascorbyl Palmitate, Tocopherol, Glycine Soja (Soybean) Oil, Mica, Titanium Dioxide, Iron Oxides, Red 7 Lake, Blue 1 Lake

Questions?

Call toll free 800-480-4812 or 215-273-8755 (collect) or visit www.neutrogena.com

SPL UNCLASSIFIED SECTION

Distributed by:

JOHNSON & JOHNSON

CONSUMER INC.

Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - 10 g Tube Label, Shine 30

LIP

SOOTHER

MOISTURE SHINE

cooling hydragel

promotes hydration

for smooth lips

sunscreen

SPF 20

SHINE 30

Neutrogena ®

NET WT. 0.35 OZ. (10G)

PRINCIPAL DISPLAY PANEL - 10 g Tube Label, Gleam 40

LIP

SOOTHER

MOISTURE SHINE

cooling hydragel

promotes hydration

for smooth lips

sunscreen

SPF 20

GLEAM 40

Neutrogena ®

NET WT. 0.35 OZ. (10G)

PRINCIPAL DISPLAY PANEL - 10 g Tube Label, Glaze 60

LIP

SOOTHER

MOISTURE SHINE

cooling hydragel

promotes hydration

for smooth lips

sunscreen

SPF 20

GLAZE 60

Neutrogena ®

NET WT. 0.35 OZ. (10G)

PRINCIPAL DISPLAY PANEL - 10 g Tube Label, Glow 70

LIP

SOOTHER

MOISTURE SHINE

cooling hydragel

promotes hydration

for smooth lips

sunscreen

SPF 20

GLOW 70

Neutrogena ®

NET WT. 0.35 OZ. (10G)

INGREDIENTS AND APPEARANCE

NEUTROGENA MOISTURESHINE LIP SOOTHER WITH SUNSCREEN SPF 20, SHINE 30 
avobenzone, homosalate, octocrylene gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0849
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
DIISOCETYL DODECANEDIOATE (UNII: 1116DS0SNT)
CASTOR OIL (UNII: D5340Y2I9G)
POLYGLYCERYL-3 STEARATE (UNII: 8FDA8C98S3)
TOCOPHEROL (UNII: R0ZB2556P8)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
OCTYLDODECANOL (UNII: 461N1O614Y)
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)
FERROUS OXIDE (UNII: G7036X8B5H)
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)
DOCOSANOL (UNII: 9G1OE216XY)
SAFFLOWER OIL (UNII: 65UEH262IS)
MENTHOL (UNII: L7T10EIP3A)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CHAMOMILE (UNII: FGL3685T2X)
SYNTHETIC BEESWAX (UNII: 08MNR5YE2R)
CUCUMBER (UNII: YY7C30VXJT)
SACCHARINA LATISSIMA (UNII: 68CMP2MB55)
SPIRULINA MAXIMA (UNII: 9K7IG15M0Q)
SACCHARIN (UNII: FST467XS7D)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
SOYBEAN OIL (UNII: 241ATL177A)
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0849-1	10 g in 1 TUBE; Type 0: Not a Combination Product	04/11/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	04/11/2024

NEUTROGENA MOISTURESHINE LIP SOOTHER WITH SUNSCREEN SPF 20, GLOW 70 
avobenzone, homosalate, octocrylene gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0852
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
STANNIC OXIDE (UNII: KM7N50LOS6)
GLYCERIN (UNII: PDC6A3C0OX)
DIISOCETYL DODECANEDIOATE (UNII: 1116DS0SNT)
CASTOR OIL (UNII: D5340Y2I9G)
POLYGLYCERYL-3 STEARATE (UNII: 8FDA8C98S3)
TOCOPHEROL (UNII: R0ZB2556P8)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
OCTYLDODECANOL (UNII: 461N1O614Y)
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)
FERROUS OXIDE (UNII: G7036X8B5H)
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)
DOCOSANOL (UNII: 9G1OE216XY)
SAFFLOWER OIL (UNII: 65UEH262IS)
MENTHOL (UNII: L7T10EIP3A)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CHAMOMILE (UNII: FGL3685T2X)
SYNTHETIC BEESWAX (UNII: 08MNR5YE2R)
CUCUMBER (UNII: YY7C30VXJT)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
SACCHARINA LATISSIMA (UNII: 68CMP2MB55)
SPIRULINA MAXIMA (UNII: 9K7IG15M0Q)
SACCHARIN (UNII: FST467XS7D)
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
SOYBEAN OIL (UNII: 241ATL177A)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0852-1	10 g in 1 TUBE; Type 0: Not a Combination Product	04/11/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	04/11/2024

NEUTROGENA MOISTURESHINE LIP SOOTHER WITH SUNSCREEN SPF 20, GLEAM 40 
avobenzone, homosalate, octocrylene gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0850
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
DIISOCETYL DODECANEDIOATE (UNII: 1116DS0SNT)
CASTOR OIL (UNII: D5340Y2I9G)
POLYGLYCERYL-3 STEARATE (UNII: 8FDA8C98S3)
TOCOPHEROL (UNII: R0ZB2556P8)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
OCTYLDODECANOL (UNII: 461N1O614Y)
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)
DOCOSANOL (UNII: 9G1OE216XY)
SAFFLOWER OIL (UNII: 65UEH262IS)
MENTHOL (UNII: L7T10EIP3A)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CHAMOMILE (UNII: FGL3685T2X)
SYNTHETIC BEESWAX (UNII: 08MNR5YE2R)
CUCUMBER (UNII: YY7C30VXJT)
SACCHARINA LATISSIMA (UNII: 68CMP2MB55)
SPIRULINA MAXIMA (UNII: 9K7IG15M0Q)
SACCHARIN (UNII: FST467XS7D)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
SOYBEAN OIL (UNII: 241ATL177A)
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0850-1	10 g in 1 TUBE; Type 0: Not a Combination Product	04/11/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	04/11/2024

NEUTROGENA MOISTURESHINE LIP SOOTHER WITH SUNSCREEN SPF 20, GLAZE 60 
avobenzone, homosalate, octocrylene gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0851
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
DIISOCETYL DODECANEDIOATE (UNII: 1116DS0SNT)
CASTOR OIL (UNII: D5340Y2I9G)
POLYGLYCERYL-3 STEARATE (UNII: 8FDA8C98S3)
TOCOPHEROL (UNII: R0ZB2556P8)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
OCTYLDODECANOL (UNII: 461N1O614Y)
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)
DOCOSANOL (UNII: 9G1OE216XY)
SAFFLOWER OIL (UNII: 65UEH262IS)
MENTHOL (UNII: L7T10EIP3A)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CHAMOMILE (UNII: FGL3685T2X)
SYNTHETIC BEESWAX (UNII: 08MNR5YE2R)
CUCUMBER (UNII: YY7C30VXJT)
SACCHARINA LATISSIMA (UNII: 68CMP2MB55)
SPIRULINA MAXIMA (UNII: 9K7IG15M0Q)
SACCHARIN (UNII: FST467XS7D)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
SOYBEAN OIL (UNII: 241ATL177A)
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0851-1	10 g in 1 TUBE; Type 0: Not a Combination Product	04/11/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	04/11/2024

Labeler - Kenvue Brands LLC (118772437)