FDA.reportPublic FDA data

Neutrogena Revitalizing Lip Balm Broad Spectrum SPF 20 - Soft Caramel 50

Product NDC
69968-0883
11-digit product format
699680883
Labeler code
69968
Product ID
69968-0883_3e0c4ddf-af7e-7bba-e063-6294a90a6cc1
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octocrylene
Dosage form
STICK
Route
TOPICAL
Labeler
Kenvue Brands LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-05-15
Substance
OCTOCRYLENE; AVOBENZONE; HOMOSALATE
Active strength
100; 30; 60 mg/g; mg/g; mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Neutrogena Revitalizing Lip Balm Broad Spectrum SPF 20 - Soft Caramel 50
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTOCRYLENE100 mg/g
AVOBENZONE30 mg/g
HOMOSALATE60 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
V06SV4M95SInternal UNII lookup
5A68WGF6WMInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
16ac7877-8dfd-3d69-e063-6394a90a5a8aAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0883-1Neutrogena Revitalizing Lip Balm Broad Spectrum SPF 20 - Soft Caramel 504.2 g in 1 CANISTERSTICK4.24
69968-0883-1Neutrogena Revitalizing Lip Balm Broad Spectrum SPF 20 - Soft Caramel 501 in 1 BLISTER PACKSTICK14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0883NEUTROGENA REVITALIZING LIP BALM BROAD SPECTRUM SPF 20 - HEALTHY BLUSH 20 (AVOBENZONE, HOMOSALATE, OCTOCRYLENE) STICK NEUTROGENA REVITALIZING LIP BALM BROAD SPECTRUM SPF 20 - SHEER SHIMMER 10 (AVOBENZONE, HOMOSALATE, OCTOCRYLENE) STICK NEUTROGENA REVITALIZING LIP BALM BROAD SPECTRUM SPF 20 - SUNNY BERRY 30 (AVOBENZONE, HOMOSALATE, OCTOCRYLENE) STICK NEUTROGENA REVITALIZING LIP BALM BROAD SPECTRUM SPF 20 - FRESH PLUM 60 (AVOBENZONE, HOMOSALATE, OCTOCRYLENE) STICK NEUTROGENA REVITALIZING LIP BALM BROAD SPECTRUM SPF 20 - PETAL GLOW 40 (AVOBENZONE, HOMOSALATE, OCTOCRYLENE) STICK NEUTROGENA REVITALIZING LIP BALM BROAD SPECTRUM SPF 20 - SOFT CARAMEL 50 (AVOBENZONE, HOMOSALATE, OCTOCRYLENE) STICK [KENVUE BRANDS LLC]2Current NDC, 2 package rows20241102_16ac7877-8dfd-3d69-e063-6394a90a5a8a.zip

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 121 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bio H Plus Daily Defense And RevitalizeZINC OXIDEBIOHEALTH PLUS LLC3765331e-ad4b-5661-e063-6294a90a7c202025-12-15Exact identifier
application number: M020
Facial Mineral FusionTITANIUM DIOXIDE, ZINC OXIDEIT INTELLIGENT TREATMENT LLC35944621-e6fb-cd98-e063-6294a90aa6412025-12-15Exact identifier
application number: M020
Face LoveZINC OXIDECLARITY SKIN CARE STUDIO, INC.35d043a7-7269-469f-e063-6294a90a1a4d2025-12-15Exact identifier
application number: M020
Mineral MousseTITANIUM DIOXIDE, ZINC OXIDECLARITY SKIN CARE STUDIO, INC.35d00778-3857-ce8f-e063-6394a90ab3752025-12-15Exact identifier
application number: M020
Chem-Free Sunscreen Non-Tinted FormulaZINC OXIDEIT INTELLIGENT TREATMENT LLC3594d573-c680-62c9-e063-6294a90a42292025-12-15Exact identifier
application number: M020
Chem Free Sunscreen Tinted FormulaZINC OXIDEIT INTELLIGENT TREATMENT LLC35948531-37ef-1fce-e063-6294a90ae79b2025-12-15Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDER. Sonia Batra, MD, Inc.35933039-8beb-9f98-e063-6394a90a60bb2025-12-15Exact identifier
application number: M020
Simply Protected Tinted Mineral SunscreenZINC OXIDEHealthy Skin & Body LLC380416b9-180a-3904-e063-6294a90a7bee2025-12-15Exact identifier
application number: M020
Non-Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDER. Sonia Batra, MD, Inc.3592edca-cab0-6c44-e063-6294a90a17272025-12-15Exact identifier
application number: M020
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEHealthy Skin & Body LLC38046e71-f171-7e96-e063-6294a90a1f0b2025-12-15Exact identifier
application number: M020
Barrier Plus Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEHealthy Skin & Body LLC38038beb-d0f0-ced2-e063-6294a90ac4232025-12-15Exact identifier
application number: M020
Extreme Protection Non TintedZINC OXIDEBIOHEALTH PLUS LLC3764cbeb-55f5-4a9c-e063-6394a90a863d2025-12-15Exact identifier
application number: M020
Happy Mineral Sunscreen Primer SPFTITANIUM DIOXIDE, ZINC OXIDEACNE CLINIC LAS VEGAS BY JUSTINA37d9c5f2-f414-6efa-e063-6294a90a927f2025-12-15Exact identifier
application number: M020
Comfort Mineral Mousse SunscreenTITANIUM DIOXIDE, ZINC OXIDEBIOHEALTH PLUS LLC3765dd17-ffbd-bcf4-e063-6394a90a2c2b2025-12-15Exact identifier
application number: M020
Prime And Protect DewyZINC OXIDEKalon Skin Studio, LLC3593cefe-a08f-eb88-e063-6394a90aaff62025-12-15Exact identifier
application number: M020
GlowZINC OXIDEGODDESSLYNNEBODYANDSKIN37247365-33ee-563d-e063-6394a90a249e2025-12-15Exact identifier
application number: M020
Prime And Protect MatteTITANIUM DIOXIDE, ZINC OXIDEKalon Skin Studio, LLC35939630-1166-1c70-e063-6294a90aac6b2025-12-15Exact identifier
application number: M020
Non-Tinted 20% Zinc Mineral SunscreenZINC OXIDEBELLA MEDICAL SKIN CARE36d9d83b-7da5-a006-e063-6394a90a9d842025-12-15Exact identifier
application number: M020
Non-Tinted 20% Zinc Mineral SunscreenZINC OXIDEBELLA MEDICAL SKIN CARE36da1a55-c076-cdd9-e063-6294a90ac97c2025-12-15Exact identifier
application number: M020
Tinted Lip BalmTITANIUM DIOXIDE, ZINC OXIDEGoldberg, Howard S MD Inc3598205d-2e87-9292-e063-6294a90a1f2a2025-12-15Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69968-0883-1699680883011 CANISTER in 1 BLISTER PACK (69968-0883-1) / 4.2 g in 1 CANISTER1 canister2024-05-15NoNoCurrent