PRIDEFUL SPF 15 LIP BALM-passion fruit

Product NDC
82866-005
11-digit product format
828660005
Labeler code
82866
Product ID
82866-005_089fcbdc-abce-8534-e063-6394a90a2923
Type
HUMAN OTC DRUG
Nonproprietary name
HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE
Dosage form
STICK
Route
TOPICAL
Labeler
PRIDEFUL LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-07-28
Substance
HOMOSALATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE
Active strength
100; 50; 30; 20 mg/g; mg/g; mg/g; mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
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
PRIDEFUL SPF 15 LIP BALM-passion fruit
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HOMOSALATE100 mg/g
OCTISALATE50 mg/g
OCTOCRYLENE30 mg/g
AVOBENZONE20 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V06SV4M95SInternal UNII lookup
4X49Y0596WInternal UNII lookup
5A68WGF6WMInternal UNII lookup
G63QQF2NOXInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d6b6389b-c8bd-4aca-8ccf-455dbc22070dAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82866-005-00PRIDEFUL SPF 15 LIP BALM-passion fruit3 g in 1 TUBESTICK32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82866-005PRIDEFUL SPF 15 LIP BALM-PASSION FRUIT (HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE) STICK [PRIDEFUL LLC]2Current NDC, Legacy NDC, 1 package rows20231027_d6b6389b-c8bd-4aca-8ccf-455dbc22070d.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 275 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IPKN Moist and Firm Beauty Balm Light MediumTITANIUM DIOXIDEInel Cosmetics Co., Ltd.1af6184e-3dc4-4eb3-8d51-aca7244734512024-10-25WarningsExact identifier
application number: M020
IPKN Moist and Firm Beauty Balm LightTITANIUM DIOXIDEInel Cosmetics Co., Ltd.77d77838-aa13-4939-a1a0-50189fbb3fe02024-10-25WarningsExact identifier
application number: M020
Dove Men plus Care Hydrate FaceAVOBENZONE, ENSULIZOLE, OCTISALATE, OCTOCRYLENECONOPCO Inc. d/b/a Unileverafe75aff-c056-eaf7-e053-2a95a90af71b2024-10-24WarningsExact identifier
application number: M020
Cancer Council Mineral Fluid SPF50ZINC OXIDEVitality US Co.1638f8a4-a2da-4e1f-e063-6294a90a03d92024-10-24WarningsExact identifier
application number: M020
Marlowe SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMarlowe Holdings, LLCf94bd91a-f0ab-680c-e053-6394a90ac8552024-10-23WarningsExact identifier
application number: M020
Vacation Broad Spectrum SPF 30HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEVacation Inc.2526eadf-4b55-ff81-e063-6394a90a3ba72024-10-23WarningsExact identifier
application number: M020
Tenacious ErgodyneKREWD CLEAR SPF 50 CONTINUOUS SPRAYTenacious Holdings, Inc.55d99d0a-dc7f-4915-b7c1-f999c8b36e0d2024-10-23WarningsExact identifier
application number: M020
Tenacious ErgodyneSPF 50 SUNSCREEN LOTIONTenacious Holdings, Inc.aaaa1f54-1136-4062-85ba-0926351580bb2024-10-23WarningsExact identifier
application number: M020
Bull Frog SPF 50 Quik with Water Armor TechAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBULLFROG BRANDS, LLC.f706f90c-eb79-2201-e053-6394a90a2ce42024-10-23WarningsExact identifier
application number: M020
Bull Frog SPF 50 Quik with Water Armor TechAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBULLFROG BRANDS, LLC.f70816a3-cc04-b000-e053-6294a90a0fae2024-10-23WarningsExact identifier
application number: M020
Alumier MD Post Procedure KitTITANIUM DIOXIDE, ZINC OXIDEAlumier Labs252859de-6676-5e07-e063-6394a90a64a12024-10-23WarningsExact identifier
application number: M020
Equate Sunscreen Tanning Oil With Coconut Oil SPF 6AVOBENZONE, HOMOSALATEWAL-MART STORES INC.f44d83d3-ffca-7a93-e053-2a95a90a77152024-10-23WarningsExact identifier
application number: M020
Tanning Sunscreen UVB Protection Dry Oil EquateAVOBENZONE, HOMOSALATE, OCTISALATEWAL-MART STORES INC.acdf62f2-742e-5df9-e053-2a95a90a96c52024-10-23WarningsExact identifier
application number: M020
WALMART EQUATE BEAUTY ULTRA LIGHT SUNSCREEN SPF 100AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEWAL-MART STORES INC.c8d4feca-7bee-2413-e053-2a95a90a739c2024-10-23WarningsExact identifier
application number: M020
Equate Sunscreen for All Skin Tones SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWal-Mart Stores Incf410ffcc-ef0e-13c4-e053-2a95a90a568a2024-10-23WarningsExact identifier
application number: M020
Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 44NHOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDERare Beauty, LLCcffbb6af-5a04-f58a-e053-2995a90a1ae22024-10-23WarningsExact identifier
application number: M020
Banana BoatTITANIUM DIOXIDE, ZINC OXIDEEdgewell Personal Care Brands, LLC441a46f0-ecda-4448-e054-00144ff88e882024-10-23WarningsExact identifier
application number: M020
Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 28CHOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDERare Beauty, LLCcffb8219-7076-de64-e053-2a95a90a60362024-10-23WarningsExact identifier
application number: M020
Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 10NHOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDERare Beauty, LLCcfee02eb-92f9-be12-e053-2a95a90a43372024-10-23WarningsExact identifier
application number: M020
CVS Pharmacy Kids SPF 70 ClearAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONECVS Pharmacy4eb824a6-66ac-01f8-e054-00144ff8d46c2024-10-22WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82866-005-00828660005003 g in 1 TUBE (82866-005-00) 3 g2022-07-280000-00-00NoNoCurrent