FDA.reportPublic FDA data

Deluxe Lip Protection

Product NDC
85403-212
11-digit product format
854030212
Labeler code
85403
Product ID
85403-212_46036c73-6783-31af-e063-6394a90a150a
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
STICK
Route
TOPICAL
Labeler
BIOHEALTH PLUS LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-06-10
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
40; 55 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
Deluxe Lip Protection
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE40 mg/g
ZINC OXIDE55 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
15FIX9V2JPInternal UNII lookup
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
37657895-5fec-82d0-e063-6294a90acf67Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85403-212-45Deluxe Lip Protection4.5 g in 1 CYLINDERSTICK4.52
85403-212-45Deluxe Lip Protection1 in 1 CARTONSTICK12

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 6 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30CORBY, JR., TERRY L.594443fd-8e27-4ec6-e063-6294a90a3ff02026-08-17WarningsExact identifier
application number: M020
Meraki Protective Mist SunscreenBROAD SPECTRUM SPF 30MERAKI MEDICAL SPA LLC59446224-0e97-ae2c-e063-6394a90a2a652026-08-17WarningsExact identifier
application number: M020
Sun Zapper - Acne Pure Zinc Sunscreen SPF50ZINC OXIDEVeganic SKN Limited3ee435a5-70fb-0c8a-e063-6394a90a650a2026-08-16WarningsExact identifier
application number: M020
Sun Zapper - Anti-ageing pure zinc sunscreen SPF30ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED3f1dc3b2-c289-5996-e063-6394a90ac6222026-08-16WarningsExact identifier
application number: M020
ISNTREE HYALURONIC ACID SENSITIVE SUNSCREENZINC OXIDEISNTREE Inc.58e38665-0bca-fb02-e063-6394a90ad62a2026-08-13WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Daily Face Sunscreen Broad Spectrum SPF 70AVOBENZONE, BEMOTRIZINOL, HOMOSALATE, OCTISALATEKenvue Brands LLC58d3d390-8b88-a6fe-e063-6394a90a9bf82026-08-12WarningsExact identifier
application number: M020
Neutrogena Clear Face Sunscreen Acne Prone Skin Broad Spectrum SPF 60AVOBENZONE, BEMOTRIZINOL, HOMOSALATE, OCTISALATEKenvue Brands LLC58d7a3e3-b7df-43ce-e063-6294a90a729c2026-08-12WarningsExact identifier
application number: M020
HEB 50 Marigold Scent SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.B.58dafa24-24d5-aeb4-e063-6394a90a3c252026-08-12WarningsExact identifier
application number: M020
TESALOVA Coconut SPF 30 Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONETesalova Viktoriia PMU LLC58dbb9f1-cfb3-62ac-e063-6394a90a61062026-08-12WarningsExact identifier
application number: M020
Elta MD Skincare UV Stick Broad Spectrum SPF50ZINC OXIDECP Skin Health Group, Inc58dd81db-46d4-d763-e063-6394a90abb0b2026-08-12WarningsExact identifier
application number: M020
Basin Coconut SPF 30 Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONERetail Concepts of Minnesota, Inc.4a8e93a6-dcf9-3687-e063-6394a90a73ac2026-08-12WarningsExact identifier
application number: M020
UV Skin Recovery SPF 50 Red CorrectingZINC OXIDECP Skin Health Group, Inc.26e63890-d1af-d171-e063-6394a90af8282026-08-12WarningsExact identifier
application number: M020
UV Skin Recovery SPF 50ZINC OXIDECP Skin Health Group, Inc.26d2683f-cfd5-50fd-e063-6394a90a75762026-08-12WarningsExact identifier
application number: M020
doTERRA Sun BodyMINERAL SUNSCREENdoTERRA International, LLC58dcc56f-f093-469c-e063-6394a90a60882026-08-12WarningsExact identifier
application number: M020
Sonage Protec Plus SPF 30 Mineral SunscreenZINC OXIDEASA Universal Inc. dba: Sonaged92fc1df-bbeb-592a-e053-2a95a90a69512026-08-12WarningsExact identifier
application number: M020
Colorescience Total Protection Body Shield GlowZINC OXIDEColorescience52e1d987-a4f8-195e-e063-6294a90a56292026-08-11WarningsExact identifier
application number: M020
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DR. SAMRAO'S OFFICE58b2ca35-11ed-d848-e063-6294a90a5b372026-08-11WarningsExact identifier
application number: M020
Ciele Tint and ProtectZINC OXIDECiele0162d9c9-07fa-9210-e063-6294a90aa6872026-08-11WarningsExact identifier
application number: M020
NeoStrata Skin Active Matrix Support SPF 30AVOBENZONE, OCTINOXATE, AND OCTISALATENeoStrata Company Inc.8e4b9c08-b906-4c5f-a243-55838ae28b902026-08-10WarningsExact identifier
application number: M020
Sunscreen for Kids SPF 50AVOBENZONE, HOMOSALATE, OCTISALATEThe Kroger Co.1c7cd904-ffff-48aa-91bd-cc978946b36a2026-08-10Warnings, Adverse reactionsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85403-212-45854030212451 CYLINDER in 1 CARTON (85403-212-45) / 4.5 g in 1 CYLINDER1 cylinder2022-06-10NoNoCurrent