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 185 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ELROEL Pang Pang Sun Cushion PlusZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATEMONOGLOT HOLDINGS Inc.5ffaad65-f0b2-416a-b0a3-b92e880641e42025-09-18WarningsExact identifier
application number: M020
e.l.f. Camo CC Cream SPF 30 Fair 125 CHOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDEe.l.f. Cosmetics, Inc.407f9c0d-31c6-f5bb-e063-6394a90a4db42025-09-18WarningsExact identifier
application number: M020
Neutrogena Collagen Bank SPF Moisturizer Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKenvue Brands LLC1630feee-7e0d-c6f4-e063-6294a90a7b1c2025-09-17WarningsExact identifier
application number: M020
Guise Tinted DropsZINC OXIDEDonis Men LLC3f039049-5004-2888-e063-6294a90a51502025-09-17WarningsExact identifier
application number: M020
ONE SIZE ON TIL DAWNONE SIZE ON TIL DAWNPogi Beauty LLC3f05d90b-9274-4d21-e063-6294a90a84852025-09-17WarningsExact identifier
application number: M020
PUR 4-in-1 Skin Tint DP3ZINC OXIDEPUR Minerals3f073413-b314-e5da-e063-6394a90a9ab42025-09-17WarningsExact identifier
application number: M020
e.l.f. Hydrating Camo CC Cream SPF30 Fair 100 WHOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDEe.l.f. Cosmetics, Inc.3fa7ef54-2c4d-9883-e063-6294a90a8d882025-09-17WarningsExact identifier
application number: M020
CVS SPF 50 Face SunscreenTITANIUM DIOXIDE, ZINC OXIDECVS26a69a47-947a-a478-e063-6394a90aa4682025-09-16WarningsExact identifier
application number: M020
SkinSuit TM 3 in 1 Moisturizer SPF 50ZINC OXIDESkin Authority LLC5eb27be9-9e80-4f4a-b193-b918d831555d2025-09-15WarningsExact identifier
application number: M020
Sun and Honey Tallow Sunscreen SPF 30ZINC OXIDEAmara Ventures3eda8a70-7c9e-e920-e063-6394a90a85a22025-09-15WarningsExact identifier
application number: M020
Klein Tools Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKLEIN TOOLS, INC.3edcc26a-d960-3fa8-e063-6394a90ab7032025-09-15WarningsExact identifier
application number: M020
Klein Tools Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTOCRYLENEKLEIN TOOLS, INC.3ede5e54-4c9f-02f7-e063-6294a90a9df62025-09-15WarningsExact identifier
application number: M020
I.C. Industrial SunscreenZINC OXIDE, OCTINOXATE, OXYBENZONE, AND OCTISALATER & R Lotion, Incb89d687a-7b36-4643-9817-765d4710ca602025-09-15WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Body Mist Sunscreen Broad Spectrum SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC97795f0e-d867-4e17-b7c9-ede08e7df70c2025-09-12WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 36N DeepZINC OXIDEDOLCE & GABBANA BEAUTY S.R.L.2d05659c-57d2-4faf-ab67-1b8d68945aed2025-09-12WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 37W DeepZINC OXIDEDOLCE & GABBANA BEAUTY S.R.L.5ff2b9e4-a778-4667-8c3c-3561317b374a2025-09-12WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 39N DeepZINC OXIDEDOLCE & GABBANA BEAUTY S.R.L.bc4f909f-3e2c-4fd7-a129-3c2fac8259f02025-09-12WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 40C DeepZINC OXIDEDOLCE & GABBANA BEAUTY S.R.L.2dd9a30a-2cde-44c0-9350-3aeab9f7091b2025-09-12WarningsExact identifier
application number: M020
Dolce and Gabbana Get Your Healthy Glowy Skin Bergamot Glow Primer Blueberry Nutri TintZINC OXIDEDolce & Gabbana Beauty S.R.Le375412e-8685-49a2-b1b0-00ab114e14b72025-09-12WarningsExact identifier
application number: M020
Beach Club Mineral SunscreenZINC OXIDE, OCTINOXATE, OXYBENZONE, AND OCTISALATER & R Lotion, Incd9aae241-229e-4123-abe9-99f74f5ab0b32025-09-12WarningsExact 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