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
5A68WGF6WMInternal UNII lookup
V06SV4M95SInternal 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 222 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION 110OCTINOXATESHISEIDO AMERICAS CORPORATION393ce1fa-f188-45d0-a23e-2818de9749952025-03-13WarningsExact identifier
application number: M020
SHISEIDO FUTURE solution LX TOTAL PROTECTIVE SAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATION1a304bf0-dcda-4887-9738-54ce35ca503b2025-03-13WarningsExact identifier
application number: M020
SHISEIDO REVITALESSENCE SKIN GLOW PRIMERAVOBENZONE, OCTINOXATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATION805fd75e-3c53-4ddd-afdc-a65f921822d42025-03-13WarningsExact identifier
application number: M020
Visor Clear Body Oil-Free Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEVISOR SKINCARE LLC10abc330-7d45-4049-b80a-dbf58374187e2025-03-12WarningsExact identifier
application number: M020
Visor Clear Face Oil-Free Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEVISOR SKINCARE LLC462acd16-b9c0-4f02-b297-d9b54036b5312025-03-12WarningsExact identifier
application number: M020
HAWAIIAN TROPICHOMOSALATE,OCTOCRYLENE,OCTISALATE,AVOBENZONEEdgewell Personal Care Brands LLC302982a3-e3f9-ef46-e063-6394a90abaf82025-03-12WarningsExact identifier
application number: M020
Neutrogena Pure And Free Sunscreen Broad Spectrum SPF 50ZINC OXIDEKenvue Brands LLC41ff1a98-69ff-4d7a-bc89-d986a803cee32025-03-10WarningsExact identifier
application number: M020
Sheer Mineral Antioxidant Sunscreen SPF50ZINC OXIDETopiderm, Inc.1af53e89-debe-4f4c-b0ef-eec2073228df2025-03-07WarningsExact identifier
application number: M020
COOLA Firming Face Serum Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE SUNSCREEN SERUMCOOLA LLC85fd7ef4-ed08-4a69-8293-5f3f3d264c042025-03-06WarningsExact identifier
application number: M020
GOLDEN HOUR HYDRATING SPF 30OCTOCRYLENE, OCTISALATE, AND AVOBENZONEDermalogica, LLC.090b5861-20f5-43c6-aff6-d17d61e8568e2025-03-04WarningsExact identifier
application number: M020
Aveeno Baby continuous protection sensitive skin Sunscreen Broad Spectrum SPF50ZINC OXIDEKenvue Brands LLCbbd6710f-a665-437e-b86b-437f732984d12025-03-04WarningsExact identifier
application number: M020
LBEL DIVINE DOUBLE USE LONGWEAR 36H SPF 15 CREME 110OCTINOXATE, ZINC OXIDEBELSTAR S.A.2f8607c5-b5ab-ed81-e063-6394a90a34532025-03-04WarningsExact identifier
application number: M020
ADVANCED PROTECTION SUNSCREEN SPF-30OCTINOXATE, OCTISALATE, ZINC OXIDEBOTANICAL SCIENCE, INC.2f8bbd08-d199-03bd-e063-6294a90adfac2025-03-04WarningsExact identifier
application number: M020
MINERAL TINTED SPF 30TITANIUM DIOXIDE, ZINC OXIDEBOTANICAL SCIENCE, INC.2f9e2252-fb54-363f-e063-6294a90aa7c92025-03-04WarningsExact identifier
application number: M020
LBEL LUMI-AGE ANTI-AGING HYDRATING DAY FACIAL SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENEBEL STAR S.A.2f717492-347d-5bf8-e063-6294a90a4b5f2025-03-03WarningsExact identifier
application number: M020
CoTZ Kids Mineral Sun StickTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD2f7225d0-ddfa-e19a-e063-6294a90a52a82025-03-03WarningsExact identifier
application number: M020
Sum 37 Micro Active Daily Moisture SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELG HOUSEHOLD & HEALTH CARE LTD.2eea94e1-2409-8ad6-e063-6294a90a5df82025-03-03WarningsExact identifier
application number: M020
Sun Defense Minerals (Fair)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2e21c9f9-acf8-997b-e063-6394a90ada3f2025-03-01WarningsExact identifier
application number: M020
Sun Defense Minerals (Medium)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2e232e8d-4274-68bc-e063-6394a90a942b2025-03-01WarningsExact identifier
application number: M020
Sun Defense Minerals (Deep)ZINC OXIDEEminence Organic Skin Care2e23d463-fbc1-5718-e063-6294a90a72722025-03-01WarningsExact 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