FDA.reportPublic FDA data

Neutrogena Revitalizing Lip Balm

Manufacturer
Kenvue Brands LLC
Effective date
2024-11-11
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:36:54

Label at a glance#

ProductNeutrogena Revitalizing Lip Balm SPF 20 - Fresh Plum 60
Active ingredientOCTINOXATE, OXYBENZONE
Label structure16 sections

Indications and uses

helps prevent sunburn

Dosage and administration

apply liberally 15 minutes before sun exposure use a water resistant sunscreen if swimming or sweating reapply at least every 2 hours children under 6 months of age: Ask a doctor

Storage and handling

protect this product from excessive heat and direct sun may stain some fabrics

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7.5%, Oxybenzone 5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn

Warnings

WARNINGS SECTION

  • Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
  • For external use only

OTC - DO NOT USE SECTION

  • Do not use on damaged or broken skin

OTC - WHEN USING SECTION

  • When using this product keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

  • Stop use and ask a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

For Sunscreen Use

SPL UNCLASSIFIED SECTION

  • apply liberally 15 minutes before sun exposure
  • use a water resistant sunscreen if swimming or sweating
  • reapply at least every 2 hours
  • children under 6 months of age: Ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • protect this product from excessive heat and direct sun
  • may stain some fabrics

Inactive ingredients

INACTIVE INGREDIENT SECTION

hydrogenated polyisobutene, petrolatum, polybutene, phenyl trimethicone, hydrogenated lanolin, ozokerite, myristyl myristate, polyethylene, cetyl lactate, butyrospermum parkii (shea) butter, bis-behenyl/isostearyl/phytosteryl dimer dilinoleyl dimer dilinoleate, euphorbia cerifera (candelilla) wax, silica, zinc, stearoxymethicone/dimethicone copolymer, copernicia cerifera (carnauba) wax, synthetic wax, ethylhexyl palmitate, tribehenin, sorbitan isostearate, palmitoyl oligopeptide, silica silylate, flavor, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, isopropyl titanium triisostearate, aluminum hydroxide, stearic acid, copper powder, mica, titanium dioxide, iron oxides, red 7

Questions or comments?

OTC - QUESTIONS SECTION

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 - 4.2 g Tube Blister Pack - Fresh Plum 60

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FRESH
PLUM 60
SHEER TINT

revitalizing
lip balm
with
sunscreen
SPF 20

Softer, rosier and healthier-looking
lips, even after you take it off!
dramatization

before                  after

Neutrogena®

NET WT 0.15 OZ (4.2 g)

PRINCIPAL DISPLAY PANEL - 4.2 g Tube Blister Pack - Fresh Plum 60
PRINCIPAL DISPLAY PANEL - 4.2 g Tube Blister Pack - Fresh Plum 60

PRINCIPAL DISPLAY PANEL - 4.2 g Tube Blister Pack - Sheer Shimmer 10

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SHEER
SHIMMER 10
SHEER TINT

revitalizing
lip balm
with
sunscreen
SPF 20

Softer, rosier and healthier-looking
lips, even after you take it off!
dramatization

before                  after

Neutrogena®

NET WT 0.15 OZ (4.2 g)

PRINCIPAL DISPLAY PANEL - 4.2 g Tube Blister Pack - Sheer Shimmer 10
PRINCIPAL DISPLAY PANEL - 4.2 g Tube Blister Pack - Sheer Shimmer 10

PRINCIPAL DISPLAY PANEL - 4.2 g Tube Blister Pack - Soft Caramel 50

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SOFT
CARAMEL 50
SHEER TINT

revitalizing
lip balm
with
sunscreen
SPF 20

Softer, rosier and healthier-looking
lips, even after you take it off!
dramatization

before                  after

Neutrogena®

NET WT 0.15 OZ (4.2 g)

PRINCIPAL DISPLAY PANEL - 4.2 g Tube Blister Pack - Soft Caramel 50
PRINCIPAL DISPLAY PANEL - 4.2 g Tube Blister Pack - Soft Caramel 50

PRINCIPAL DISPLAY PANEL - 4.2 g Tube Blister Pack - Healthy Blush 20

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HEALTHY
BLUSH 20
SHEER TINT

revitalizing
lip balm
with
sunscreen
SPF 20

Softer, rosier and healthier-looking
lips, even after you take it off!
dramatization

before                  after

Neutrogena®

NET WT 0.15 OZ (4.2 g)

PRINCIPAL DISPLAY PANEL - 4.2 g Tube Blister Pack - Healthy Blush 20
PRINCIPAL DISPLAY PANEL - 4.2 g Tube Blister Pack - Healthy Blush 20

PRINCIPAL DISPLAY PANEL - 4.2 g Tube Blister Pack - Sunny Berry 30

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SUNNY
BERRY 30
SHEER TINT

revitalizing
lip balm
with
sunscreen
SPF 20

Softer, rosier and healthier-looking
lips, even after you take it off!
dramatization

before                  after

Neutrogena®

NET WT 0.15 OZ (4.2 g)

PRINCIPAL DISPLAY PANEL - 4.2 g Tube Blister Pack - Sunny Berry 30
PRINCIPAL DISPLAY PANEL - 4.2 g Tube Blister Pack - Sunny Berry 30

PRINCIPAL DISPLAY PANEL - 4.2 g Tube Blister Pack - Petal Glow 40

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PETAL
GLOW 40
SHEER TINT

revitalizing
lip balm
with
sunscreen
SPF 20

Softer, rosier and healthier-looking
lips, even after you take it off!
dramatization

before                  after

Neutrogena®

NET WT 0.15 OZ (4.2 g)

PRINCIPAL DISPLAY PANEL - 4.2 g Tube Blister Pack - Petal Glow 40
PRINCIPAL DISPLAY PANEL - 4.2 g Tube Blister Pack - Petal Glow 40

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c599c4a0-705d-4ebb-ab1f-977af038f96aProduct name120251124

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0251-1Neutrogena Revitalizing Lip BalmSPF 20 - Sheeer Shimmer 104.2 g in 1 TUBELIPSTICK4.27
69968-0251-1Neutrogena Revitalizing Lip BalmSPF 20 - Sheeer Shimmer 101 in 1 BLISTER PACKLIPSTICK17
69968-0252-1Neutrogena Revitalizing Lip BalmSPF 20 - Soft Caramel 504.2 g in 1 TUBELIPSTICK4.27
69968-0252-1Neutrogena Revitalizing Lip BalmSPF 20 - Soft Caramel 501 in 1 BLISTER PACKLIPSTICK17
69968-0253-1Neutrogena Revitalizing Lip BalmSPF 20 - Healthy Blush 204.2 g in 1 TUBELIPSTICK4.27
69968-0253-1Neutrogena Revitalizing Lip BalmSPF 20 - Healthy Blush 201 in 1 BLISTER PACKLIPSTICK17
69968-0254-1Neutrogena Revitalizing Lip BalmSPF 20 - Petal Glow 401 in 1 BLISTER PACKLIPSTICK17
69968-0254-1Neutrogena Revitalizing Lip BalmSPF 20 - Petal Glow 404.2 g in 1 TUBELIPSTICK4.27
69968-0255-1Neutrogena Revitalizing Lip BalmSPF 20 - Sunny Berry 301 in 1 BLISTER PACKLIPSTICK17
69968-0255-1Neutrogena Revitalizing Lip BalmSPF 20 - Sunny Berry 304.2 g in 1 TUBELIPSTICK4.27
69968-0256-1Neutrogena Revitalizing Lip BalmSPF 20 - Fresh Plum 601 in 1 BLISTER PACKLIPSTICK17
69968-0256-1Neutrogena Revitalizing Lip BalmSPF 20 - Fresh Plum 604.2 g in 1 TUBELIPSTICK4.27

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0251NEUTROGENA REVITALIZING LIP BALM SPF 20 - FRESH PLUM 60 (OCTINOXATE AND OXYBENZONE) LIPSTICK NEUTROGENA REVITALIZING LIP BALM SPF 20 - SHEEER SHIMMER 10 (OCTINOXATE AND OXYBENZONE) LIPSTICK NEUTROGENA REVITALIZING LIP BALM SPF 20 - SOFT CARAMEL 50 (OCTINOXATE AND OXYBENZONE) LIPSTICK NEUTROGENA REVITALIZING LIP BALM SPF 20 - HEALTHY BLUSH 20 (OCTINOXATE AND OXYBENZONE) LIPSTICK NEUTROGENA REVITALIZING LIP BALM SPF 20 - SUNNY BERRY 30 (OCTINOXATE AND OXYBENZONE) LIPSTICK NEUTROGENA REVITALIZING LIP BALM SPF 20 - PETAL GLOW 40 (OCTINOXATE AND OXYBENZONE) LIPSTICK [KENVUE BRANDS LLC]7Current NDC, Legacy NDC, 2 package rows20241114_e77c07d4-4e64-4000-9e7a-963aa6c6448c.zip
69968-0252NEUTROGENA REVITALIZING LIP BALM SPF 20 - FRESH PLUM 60 (OCTINOXATE AND OXYBENZONE) LIPSTICK NEUTROGENA REVITALIZING LIP BALM SPF 20 - SHEEER SHIMMER 10 (OCTINOXATE AND OXYBENZONE) LIPSTICK NEUTROGENA REVITALIZING LIP BALM SPF 20 - SOFT CARAMEL 50 (OCTINOXATE AND OXYBENZONE) LIPSTICK NEUTROGENA REVITALIZING LIP BALM SPF 20 - HEALTHY BLUSH 20 (OCTINOXATE AND OXYBENZONE) LIPSTICK NEUTROGENA REVITALIZING LIP BALM SPF 20 - SUNNY BERRY 30 (OCTINOXATE AND OXYBENZONE) LIPSTICK NEUTROGENA REVITALIZING LIP BALM SPF 20 - PETAL GLOW 40 (OCTINOXATE AND OXYBENZONE) LIPSTICK [KENVUE BRANDS LLC]7Current NDC, Legacy NDC, 2 package rows20241114_e77c07d4-4e64-4000-9e7a-963aa6c6448c.zip
69968-0253NEUTROGENA REVITALIZING LIP BALM SPF 20 - FRESH PLUM 60 (OCTINOXATE AND OXYBENZONE) LIPSTICK NEUTROGENA REVITALIZING LIP BALM SPF 20 - SHEEER SHIMMER 10 (OCTINOXATE AND OXYBENZONE) LIPSTICK NEUTROGENA REVITALIZING LIP BALM SPF 20 - SOFT CARAMEL 50 (OCTINOXATE AND OXYBENZONE) LIPSTICK NEUTROGENA REVITALIZING LIP BALM SPF 20 - HEALTHY BLUSH 20 (OCTINOXATE AND OXYBENZONE) LIPSTICK NEUTROGENA REVITALIZING LIP BALM SPF 20 - SUNNY BERRY 30 (OCTINOXATE AND OXYBENZONE) LIPSTICK NEUTROGENA REVITALIZING LIP BALM SPF 20 - PETAL GLOW 40 (OCTINOXATE AND OXYBENZONE) LIPSTICK [KENVUE BRANDS LLC]7Current NDC, Legacy NDC, 2 package rows20241114_e77c07d4-4e64-4000-9e7a-963aa6c6448c.zip
69968-0254NEUTROGENA REVITALIZING LIP BALM SPF 20 - FRESH PLUM 60 (OCTINOXATE AND OXYBENZONE) LIPSTICK NEUTROGENA REVITALIZING LIP BALM SPF 20 - SHEEER SHIMMER 10 (OCTINOXATE AND OXYBENZONE) LIPSTICK NEUTROGENA REVITALIZING LIP BALM SPF 20 - SOFT CARAMEL 50 (OCTINOXATE AND OXYBENZONE) LIPSTICK NEUTROGENA REVITALIZING LIP BALM SPF 20 - HEALTHY BLUSH 20 (OCTINOXATE AND OXYBENZONE) LIPSTICK NEUTROGENA REVITALIZING LIP BALM SPF 20 - SUNNY BERRY 30 (OCTINOXATE AND OXYBENZONE) LIPSTICK NEUTROGENA REVITALIZING LIP BALM SPF 20 - PETAL GLOW 40 (OCTINOXATE AND OXYBENZONE) LIPSTICK [KENVUE BRANDS LLC]7Current NDC, Legacy NDC, 2 package rows20241114_e77c07d4-4e64-4000-9e7a-963aa6c6448c.zip
69968-0255NEUTROGENA REVITALIZING LIP BALM SPF 20 - FRESH PLUM 60 (OCTINOXATE AND OXYBENZONE) LIPSTICK NEUTROGENA REVITALIZING LIP BALM SPF 20 - SHEEER SHIMMER 10 (OCTINOXATE AND OXYBENZONE) LIPSTICK NEUTROGENA REVITALIZING LIP BALM SPF 20 - SOFT CARAMEL 50 (OCTINOXATE AND OXYBENZONE) LIPSTICK NEUTROGENA REVITALIZING LIP BALM SPF 20 - HEALTHY BLUSH 20 (OCTINOXATE AND OXYBENZONE) LIPSTICK NEUTROGENA REVITALIZING LIP BALM SPF 20 - SUNNY BERRY 30 (OCTINOXATE AND OXYBENZONE) LIPSTICK NEUTROGENA REVITALIZING LIP BALM SPF 20 - PETAL GLOW 40 (OCTINOXATE AND OXYBENZONE) LIPSTICK [KENVUE BRANDS LLC]7Current NDC, Legacy NDC, 2 package rows20241114_e77c07d4-4e64-4000-9e7a-963aa6c6448c.zip
69968-0256NEUTROGENA REVITALIZING LIP BALM SPF 20 - FRESH PLUM 60 (OCTINOXATE AND OXYBENZONE) LIPSTICK NEUTROGENA REVITALIZING LIP BALM SPF 20 - SHEEER SHIMMER 10 (OCTINOXATE AND OXYBENZONE) LIPSTICK NEUTROGENA REVITALIZING LIP BALM SPF 20 - SOFT CARAMEL 50 (OCTINOXATE AND OXYBENZONE) LIPSTICK NEUTROGENA REVITALIZING LIP BALM SPF 20 - HEALTHY BLUSH 20 (OCTINOXATE AND OXYBENZONE) LIPSTICK NEUTROGENA REVITALIZING LIP BALM SPF 20 - SUNNY BERRY 30 (OCTINOXATE AND OXYBENZONE) LIPSTICK NEUTROGENA REVITALIZING LIP BALM SPF 20 - PETAL GLOW 40 (OCTINOXATE AND OXYBENZONE) LIPSTICK [KENVUE BRANDS LLC]7Current NDC, Legacy NDC, 2 package rows20241114_e77c07d4-4e64-4000-9e7a-963aa6c6448c.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 40 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69968-025669968-0256-1
69968-025169968-0251-1
69968-025269968-0252-1
69968-025369968-0253-1
69968-025569968-0255-1
69968-025469968-0254-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 5 · 178 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDROGENATED POLYBUTENE (1300 MW)7D1YQ9Y5EZIACT
PETROLATUM4T6H12BN9UIACT
POLYBUTENE (1400 MW)1NA5AO9GH7IACT
PHENYL TRIMETHICONEDR0K5NOJ4RIACT
LANOLIN ALCOHOLS884C3FA9HEIACT
CERESINQ1LS2UJO3AIACT
MYRISTYL MYRISTATE4042ZC00DYIACT
HIGH DENSITY POLYETHYLENEUG00KM4WR7IACT
CETYL LACTATEA7EVH2RK4OIACT
SHEA BUTTERK49155WL9YIACT
CANDELILLA WAXWL0328HX19IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
ZINCJ41CSQ7QDSIACT
CARNAUBA WAXR12CBM0EIZIACT
ETHYLHEXYL PALMITATE2865993309IACT
TRIBEHENIN8OC9U7TQZ0IACT
SORBITAN ISOSTEARATE01S2G2C1E4IACT
PALMITOYL TRIPEPTIDE-1RV743D216MIACT
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE)255PIF62MSIACT
ISOPROPYL TITANIUM TRIISOSTEARATE949E3KBJ1IIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
STEARIC ACID4ELV7Z65APIACT
COPPER789U1901C5IACT
MICAV8A1AW0880IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FERRIC OXIDE RED1K09F3G675IACT
D&C RED NO. 7ECW0LZ41X8IACT
OCTINOXATE4Y5P7MUD51ACTIB
OXYBENZONE95OOS7VE0YACTIB
HYDROGENATED POLYBUTENE (1300 MW)7D1YQ9Y5EZIACT
PETROLATUM4T6H12BN9UIACT
POLYBUTENE (1400 MW)1NA5AO9GH7IACT
PHENYL TRIMETHICONEDR0K5NOJ4RIACT
LANOLIN ALCOHOLS884C3FA9HEIACT
CERESINQ1LS2UJO3AIACT
MYRISTYL MYRISTATE4042ZC00DYIACT
HIGH DENSITY POLYETHYLENEUG00KM4WR7IACT
CETYL LACTATEA7EVH2RK4OIACT
SHEA BUTTERK49155WL9YIACT
CANDELILLA WAXWL0328HX19IACT

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Neutrogena Revitalizing Lip Balm SPF 20 - Sheeer Shimmer 10OCTINOXATE AND OXYBENZONEKenvue Brands LLCe77c07d4-4e64-4000-9e7a-963aa6c6448c2024-11-11WarningsExact identifier
ndc (package): 69968-0253-1
ndc (package): 69968-0254-1
ndc (package): 69968-0252-1
ndc (package): 69968-0251-1
ndc (package): 69968-0256-1
ndc (package): 69968-0255-1
ndc (product): 69968-0256
ndc (product): 69968-0255
ndc (product): 69968-0254
ndc (product): 69968-0253
ndc (product): 69968-0251
ndc (product): 69968-0252
ndc11 (package): 69968025101
ndc11 (package): 69968025201
ndc11 (package): 69968025301
ndc11 (package): 69968025601
ndc11 (package): 69968025501
ndc11 (package): 69968025401
spl id: 21c2e959-1b96-9042-e063-6294a90a3254
spl set id: e77c07d4-4e64-4000-9e7a-963aa6c6448c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.