FDA.reportPublic FDA data

EA EIGHT HR LIP SHEER TINTS

Product NDC
10967-674
11-digit product format
109670674
Labeler code
10967
Product ID
10967-674_0ec6e2a3-5c58-477b-e063-6294a90a8fd0
Type
HUMAN OTC DRUG
Nonproprietary name
OXYBENZONE, PADIMATE O, PETROLATUM
Dosage form
LIPSTICK
Route
TOPICAL
Labeler
REVLON
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-04-17
Substance
PADIMATE O; PETROLATUM; OXYBENZONE
Active strength
8; 30.2; 3 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
EA EIGHT HR LIP SHEER TINTS
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PADIMATE O8 mg/g
PETROLATUM30.2 mg/g
OXYBENZONE3 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
Z11006CMUZInternal UNII lookup
4T6H12BN9UInternal UNII lookup
95OOS7VE0YInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b671d630-2b71-66d2-e053-2a95a90a8461Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10967-674-612022-02-09C16284748780-1d6a99b39-80de-a426-e053-dadaa90af4c2EA 8Hr Lip Protectant Stick Sheer Tints
10967-674-612022-01-28C16284748780-1d6a99b39-80de-a426-e053-dadaa90af4c2EA 8Hr Lip Protectant Stick Sheer Tints

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10967-674-61EA EIGHT HR LIP SHEER TINTS3.7 g in 1 CARTRIDGELIPSTICK3.73

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10967-674EA EIGHT HR LIP SHEER TINTS (OXYBENZONE, PADIMATE O, PETROLATUM) LIPSTICK [REVLON]3Current NDC, Legacy NDC, 1 package rows20240113_b671d630-2b71-66d2-e053-2a95a90a8461.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 101 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
COCO AND EVE SUNNY HONEY PROTECT TAN BOOSTING ANTI-AGING SPF 45SUNSCREEN OILSoleil Collective LLC471c0eed-f7ca-3c3b-e063-6294a90ad2c62025-12-29WarningsExact identifier
application number: M020
EIGHT HOUR NOURISHING LIP SPF 20OCTINOXATE, AVOBENZONEREVLONb3c16e60-752d-6eba-e053-2995a90a2b202025-12-29WarningsExact identifier
application number: M020
CERAMIDE PREMIERE BROAD SPECTRUM SPF 30OCTINOXATE, OCTISALATE, OXYBENZONE, OCTOCRYLENE, AVOBENZONEREVLONb3358bfd-7fe5-33e2-e053-2a95a90ac2ea2025-12-29WarningsExact identifier
application number: M020
Prevage anti aging SPF 30OCTISALATE, OCTINOXATE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE,Revlonb2bff796-1579-2686-e053-2995a90ad6c72025-12-29WarningsExact identifier
application number: M020
FLAWLESS FUTURE SPF 30OCTINOXATE, OCTISALATE, OXYBENZONE, AVAOBENZONEREVLONb553aec1-5002-3a3f-e053-2995a90a22e52025-12-29WarningsExact identifier
application number: M020
Prevage Anti-aging eye cream SPF 15OCTINOXATE, OXYBENZONERevlonb2a92d72-e634-7379-e053-2995a90a2bca2025-12-29WarningsExact identifier
application number: M020
Prevage Anti-aging Moisture CreamOCTINOXATE, OCTISALATE, OXYBENZONE, OCTOCRYLENE, AVOBENZONERevlon Consumer Products Corpb247adbe-dfe8-df0a-e053-2995a90a34d92025-12-29WarningsExact identifier
application number: M020
Sheer Protection SPF 30ZINC OXIDESkin Script, LLC0450dcc9-3f8f-e2c2-e063-6294a90af60b2025-12-29WarningsExact identifier
application number: M020
RE-NUTRIV ULTRA RADIANCE MAKEUP BROAD SPECTRUM SPF 20OCTINOXATE AND TITANIUM DIOXIDEESTEE LAUDER INC897b8edb-f089-4a49-baca-e05806b0a0682025-12-29WarningsExact identifier
application number: M020
Mine Line Coconut Sunscreen SPF 50ZINC OXIDESpa de Soleil4642b1cc-43b1-6997-e063-6394a90ac7642025-12-29WarningsExact identifier
application number: M020
SnugZ SPF 30 Broad Spectrum SunscreenSPF 30 BROAD SPECTRUM SUNSCREENSnugZ/USA, LLC69ac1218-76e6-04ff-e053-2a91aa0a40802025-12-29WarningsExact identifier
application number: M020
SnugZ SPF 50 Sunscreen SprySPF 50 SUNSCREEN SPRAYSnugZ USA9390ea21-9f9f-14e2-e053-2a95a90ac5772025-12-29WarningsExact identifier
application number: M020
SnugZ SPF 15 Flavored Beeswax Lip BalmSPF 15 FLAVORED BEESWAX LIP BALMSnugZ/USA, LLC69bdfaaf-d49e-bf31-e053-2a91aa0affd32025-12-29WarningsExact identifier
application number: M020
SnugZ SPF 50 Broad Spectrum SunscreenSPF 50 BROAD SPECTRUM SUNSCREENSnugZ/USA, LLCb7a3eed5-c8ca-ffda-e053-2a95a90a73bb2025-12-29WarningsExact identifier
application number: M020
SnugZ SPF 15 Beeswax Lip BalmSPF 15 BEESWAX LIP BALMSnugZ/USA, LLC68816d3a-dbe9-7ce3-e053-2a91aa0a395e2025-12-29WarningsExact identifier
application number: M020
SnugZ SPF 30 Soy Lip BalmSPF 30 SOY LIP BALMSnugZ/USA, LLC687ff49d-2d0e-2534-e053-2991aa0a28642025-12-29WarningsExact identifier
application number: M020
SnugZ SPF 50 Sunscreen StickSPF 50 SUNSTICKSnugZ/USA, LLC6e1179cf-5bfb-1156-e053-2991aa0a5b462025-12-29WarningsExact identifier
application number: M020
OUHOE Face Body SunscreenTITANIUM DIOXIDEShantou Ouhoe Technology Co., Ltd.46d36f60-2a5d-816e-e063-6294a90a2ddc2025-12-26WarningsExact identifier
application number: M020
OUHOE Bean SunscreenTITANIUM DIOXIDEShantou Ouhoe Technology Co., Ltd.46d3b11f-93d9-0e38-e063-6294a90a41c32025-12-26WarningsExact identifier
application number: M020
CreamZINC OXIDEMONAT GLOBAL CORPe922d89c-4232-77d8-e053-2995a90a85e52025-12-26WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10967-674-61109670674613.7 g in 1 CARTRIDGE (10967-674-61) 3.7 g2019-04-170000-00-00NoNoCurrent