EIGHT HOUR LIP PROTECTANT SPF 15

Product NDC
10967-692
11-digit product format
109670692
Labeler code
10967
Product ID
10967-692_2a0ac71c-e567-5ff9-e063-6394a90a4807
Type
HUMAN OTC DRUG
Nonproprietary name
PETROLATUM, OXYBENZONE, OCTINOXATE, AVOBENZONE
Dosage form
LIPSTICK
Route
TOPICAL
Labeler
REVLON
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-11-01
Substance
AVOBENZONE; OCTINOXATE; OXYBENZONE; PETROLATUM
Active strength
2; 7.49475; 3; 30.99938 mg/g; 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
EIGHT HOUR LIP PROTECTANT SPF 15
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE2 mg/g
OCTINOXATE7.49475 mg/g
OXYBENZONE3 mg/g
PETROLATUM30.99938 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
4Y5P7MUD51Internal UNII lookup
95OOS7VE0YInternal UNII lookup
4T6H12BN9UInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2a0ac6aa-0315-d79e-e063-6294a90a9c53Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10967-692-61EIGHT HOUR LIP PROTECTANT SPF 153.7 g in 1 CARTRIDGELIPSTICK3.71

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10967-692EIGHT HOUR LIP PROTECTANT SPF 15 (PETROLATUM, OXYBENZONE, OCTINOXATE, AVOBENZONE) LIPSTICK [REVLON]1Current NDC, 1 package rows20241226_2a0ac6aa-0315-d79e-e063-6294a90a9c53.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 143 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEMaloney Plastic Surgery Skin Care, PLLC316b46ac-6dde-72d1-e063-6294a90a03da2025-12-09Exact identifier
application number: M020
ReplenishZINC OXIDEMaloney Plastic Surgery Skin Care, PLLC316c43fb-0c15-87d4-e063-6294a90a0a632025-12-09Exact identifier
application number: M020
BIOJUVE Microbiome-Safe Sheer Finish SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDECrown Laboratoriesece7565b-f3e5-3386-e053-2a95a90a58022025-12-09WarningsExact identifier
application number: M020
Hydraboost Lip TreatmentAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBluemercury2cf30083-8723-23f6-e063-6394a90a55de2025-12-09WarningsExact identifier
application number: M020
Florida Babe Sport Non-Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDETichy Anesthesia PA31e4756d-8604-6e75-e063-6294a90aebe12025-12-09Exact identifier
application number: M020
Florida Babe Sport Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDETichy Anesthesia PA31e4d9ae-f532-f9f5-e063-6294a90a8d392025-12-09Exact identifier
application number: M020
Arbonne FunSun Mineral Sunscreen Broad Spectrum SPF 30ZINC OXIDEArbonne International, LLC91bcd120-28e5-4f44-9522-550c1dbcd82c2025-12-09WarningsExact identifier
application number: M020
Florida Babe Active Tinted 20percent Zinc Oxide Mineral SunscreenZINC OXIDETichy Anesthesia PA31e509f2-dcb6-5ae0-e063-6394a90a70c12025-12-09Exact identifier
application number: M020
Florida Babe Active Non-Tinted 20percent Zinc Oxide Mineral SunscreenZINC OXIDETichy Anesthesia PA31e57817-b8c4-8178-e063-6294a90a01492025-12-09Exact identifier
application number: M020
Florida Babe Everyday Tinted Replenishing Daily ProtectionZINC OXIDETichy Anesthesia PA3231f1fe-51b3-b2e7-e063-6394a90a27582025-12-09Exact identifier
application number: M020
Florida Babe Everyday Tinted Replenishing Daily ProtectionZINC OXIDETichy Anesthesia PA31e63876-3e39-adc6-e063-6394a90ab1462025-12-09Exact identifier
application number: M020
Florida Babe SPORT Mineral Sunscreen Stick TintedTITANIUM DIOXIDE, ZINC OXIDETichy Anesthesia PA31f5bbe4-5f6e-3bef-e063-6294a90a26462025-12-09Exact identifier
application number: M020
Florida Babe SPORT Mineral Sunscreen Stick Non-TintedTITANIUM DIOXIDE, ZINC OXIDETichy Anesthesia PA31f54a79-70b7-def5-e063-6294a90a709b2025-12-09Exact identifier
application number: M020
Florida Babe Sport Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDETichy Anesthesia PA3231b71c-4d27-e5e2-e063-6294a90a031b2025-12-09Exact identifier
application number: M020
Arbonne Soft Focus Veil Broad Spectrum SPF 30 SunscreenTITANIUM DIOXIDE AND ZINC OXIDEArbonne International, LLC3c9b605b-5a16-4f89-a956-8c4c62de72d32025-12-09WarningsExact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDETHE AESTHETICS ACADEMY, LLC364b9560-f7a1-ed8f-e063-6294a90a2c412025-12-09Exact identifier
application number: M020
Sunshield Moisturizing Sunscreen and AntioxidantZINC OXIDEOculofacial Surgery andCosmetic Laser Institute, LLC.32c247fc-d4da-e03d-e063-6394a90a72b02025-12-09Exact identifier
application number: M020
SCALP SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEFOLICULE LLC387b10e1-5443-7b7a-e063-6394a90a2c7a2025-12-09Exact identifier
application number: M020
Sunshield Moisturizing Sunscreen and AntioxidantZINC OXIDEOculofacial Surgery andCosmetic Laser Institute, LLC.32c3936e-4089-edd0-e063-6294a90ad3f82025-12-09Exact identifier
application number: M020
Tinted Replenishing Daily ProtectionZINC OXIDETHE AESTHETICS ACADEMY, LLC364cf1f7-1f87-51f7-e063-6294a90a789c2025-12-09Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
10967-692-61109670692613.7 g in 1 CARTRIDGE (10967-692-61) 3.7 g2021-11-01NoNoCurrent