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 123 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Non Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDEVIDA HEALTH & WELLNESS LLC3724cb53-0198-c604-e063-6294a90aa64b2025-12-15Exact identifier
application number: M020
Untinted Sheer DefenseTITANIUM DIOXIDE, ZINC OXIDEKristina Lerner35be50b7-a9af-29ee-e063-6394a90a45ba2025-12-15Exact identifier
application number: M020
Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDEVIDA HEALTH & WELLNESS LLC3724ea3c-b018-c125-e063-6394a90a01f12025-12-15Exact identifier
application number: M020
Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDEVIDA HEALTH & WELLNESS LLC37252429-d692-c05a-e063-6294a90a6af62025-12-15Exact identifier
application number: M020
Parasol Daily Mineral SunscreenZINC OXIDEBodi & Wax, LLC35d2fbeb-935b-f0a9-e063-6294a90acd792025-12-15Exact identifier
application number: M020
BHSkin Sheer Tinted Zinc and Titanium SPF 40TITANIUM DIOXIDE, ZINC OXIDEDon Mehrabi, M.D. A Professional Medical Corporation423c7e62-ad50-0dc3-e063-6294a90ad05a2025-12-15WarningsExact identifier
application number: M020
Tined Mineral Sunscreen Whipped MousseTITANIUM DIOXIDE, ZINC OXIDEESTILO SALON & SPA LLC3699c107-d063-cc6f-e063-6394a90a6ad42025-12-15Exact identifier
application number: M020
BHSkin Sheer Tinted Zinc and Titanium SPF 40TITANIUM DIOXIDE, ZINC OXIDEDon Mehrabi, M.D. A Professional Medical Corporation44776529-3aa6-4fa3-b2ce-f624c4cf41bd2025-12-15WarningsExact identifier
application number: M020
Tinted Mineral SunscreenZINC OXIDEJMSE Management, LLC36ec860f-2066-196c-e063-6294a90a21212025-12-15Exact identifier
application number: M020
Parasol Daily Mineral SunscreenZINC OXIDEBodi & Wax, LLC35d3262a-1d8d-2afa-e063-6294a90afd492025-12-15Exact identifier
application number: M020
Parasol Daily Mineral Sunscreen Non-TintedZINC OXIDEBodi & Wax, LLC35d37c2e-abc0-6bda-e063-6294a90a8fc32025-12-15Exact identifier
application number: M020
Tined Mineral Sunscreen Whipped MousseTITANIUM DIOXIDE, ZINC OXIDEESTILO SALON & SPA LLC36999510-88f0-64fc-e063-6294a90a3d092025-12-15Exact identifier
application number: M020
Parasol Daily Mineral Sunscreen Non-TintedZINC OXIDEBodi & Wax, LLC35d3486c-c6e8-4d31-e063-6294a90a12192025-12-15Exact identifier
application number: M020
Tinted Mineral Sunscreen CreamZINC OXIDEESTILO SALON & SPA LLC3699f6df-63b8-f255-e063-6394a90af2c42025-12-15Exact identifier
application number: M020
Tinted Mineral Sunscreen CreamZINC OXIDEESTILO SALON & SPA LLC369a5997-7dbe-254d-e063-6394a90a5bef2025-12-15Exact identifier
application number: M020
Non Tinted Mineral Sunscreen 20Percent Zinc OxideZINC OXIDEESTILO SALON & SPA LLC369a8a99-c755-3c7f-e063-6394a90ac16c2025-12-15Exact identifier
application number: M020
Non Tinted Mineral Sunscreen 20Percent Zinc OxideZINC OXIDEESTILO SALON & SPA LLC369abc9d-9c20-5397-e063-6394a90a17232025-12-15Exact identifier
application number: M020
Sunshade Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEBELLAGENA SKINCARE STUDIO & SPA37dec631-fdaf-fbdf-e063-6394a90a6c2b2025-12-15Exact identifier
application number: M020
Matte Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEEDIT EUROSPA, LLC37527317-0f10-d7e6-e063-6394a90a35a62025-12-15Exact identifier
application number: M020
Sunshade Mineral Stick SunscreenTITANIUM DIOXIDE, ZINC OXIDEBELLAGENA SKINCARE STUDIO & SPA37ee31be-bfda-f052-e063-6294a90ac0bb2025-12-15Exact 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