FDA.reportPublic FDA data

ATTITUDE Oceanly Phyto-sun lip balm SPF 30 Baby Rose

Product NDC
61649-045
11-digit product format
616490045
Labeler code
61649
Product ID
61649-045_5fef55e9-6b52-913e-e063-6294a90a20f4
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc oxide
Dosage form
STICK
Route
TOPICAL
Labeler
9055-7588 Quebec Inc. DBA Attitude
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-04-01
Marketing end
2028-01-16
Substance
ZINC OXIDE
Active strength
20 g/100g
NDC exclude flag
No
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
ATTITUDE Oceanly Phyto-sun lip balm SPF 30 Baby Rose

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE20 g/100g

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61649-045-08ATTITUDE Oceanly Phyto-sun lip balm SPF 30 Baby Rose8.5 g in 1 CARTONSTICK8.52
61649-045-08ATTITUDE Oceanly Phyto-Sun Kit SPF 308.5 g in 1 CARTONSTICK8.5 g20 g in 100g2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61649-045ATTITUDE OCEANLY PHYTO-SUN KIT SPF 30 (ZINC OXIDE) KIT [9055-7588 QUEBEC INC. DBA ATTITUDE]1Current NDC20240402_0eae4b71-60be-9715-e063-6294a90af463.zip
61649-045ATTITUDE OCEANLY PHYTO-SUN LIP BALM SPF 30 BABY ROSE (ZINC OXIDE) STICK [9055-7588 QUEBEC INC. DBA ATTITUDE]1Current NDC, 1 package rows20240402_0e9d9419-a7e1-bc42-e063-6394a90af511.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 285 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Walgreens Broad Spectrum SPF 40 Radiant Facial SunscreenAVOBENZONE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANY24114416-33b9-c6ba-e063-6394a90a6f3b2024-10-09WarningsExact identifier
application number: M020
Walgreens 40 Invisible Facial Sunscreen Broad Spectrum SPF 40AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANY0c40a46b-b9f9-8e14-e063-6394a90a95732024-10-09WarningsExact identifier
application number: M020
AMOREPACIFIC COLOR CONTROL CUSHION COMPACT NO.102ZINC OXIDE, OCTINOXATE, AND TITANIUM DIOXIDEAMOREPACIFIC CORPORATION531f60c9-c89a-46bc-8460-d01b2e838e6f2024-10-08WarningsExact identifier
application number: M020
AMOREPACIFIC COLOR CONTROL CUSHION COMPACT NO.104OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDEAMOREPACIFIC CORPORATION60964d9f-d96c-4397-b273-6b63d18867222024-10-08WarningsExact identifier
application number: M020
IOPE AIR CUSHION Cover 21 VanillaZINC OXIDE, OCTINOXATE, AND TITANIUM DIOXIDEAMOREPACIFIC CORPORATION29d6cc8d-1469-479d-a15a-e78d4e22d4a22024-10-08WarningsExact identifier
application number: M020
IOPE UV DEFENSE SUN PROTECTORHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEAMOREPACIFIC CORPORATION0f2a87f7-2185-16a5-e063-6294a90a92a32024-10-08WarningsExact identifier
application number: M020
Tropical Topical Matte SPF30ZINC OXIDEAllure Labs039fba4b-720a-9199-e063-6394a90adbfb2024-10-08WarningsExact identifier
application number: M020
LANEIGE HYDRO UV DEFENSE EX BROAD SPECTRUM SPF 50OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONEAMOREPACIFIC CORPORATION0e746836-ed84-7b33-e063-6294a90aeff32024-10-08WarningsExact identifier
application number: M020
DermacinRx Skin Moisturizing Ultra SPF 50 SunscreenAVOBENZONE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDEPureTek Corporation86eb06cc-d63f-4500-a52e-14ef99a565322024-10-02WarningsExact identifier
application number: M020
TiZO2TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD43bec652-3f2c-4671-8a0c-c4c4a4bfcc7a2024-10-01WarningsExact identifier
application number: M020
PROCEUTICALS PRIVATE LABEL by TiZO eye repair non-tinted mineral sunscreenZINC OXIDEFallien Cosmeceuticals, LTD231af290-99ee-e94d-e063-6394a90a0bef2024-09-27WarningsExact identifier
application number: M020
Target Up and Up SPF 70 Sport SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETARGET CORPORATION23085ab9-5abb-a572-e063-6394a90ae34a2024-09-26WarningsExact identifier
application number: M020
Target Up and Up Morning Facial Moisturizing with SPF 30 Sunscreen and CeramidesHOMOSALATE, OCTOCRYLENE, ZINC OXIDETARGET CORPORATION23598ad1-12a3-fe65-e063-6394a90a4f6f2024-09-26WarningsExact identifier
application number: M020
Target Up and Up SPF 30 Sport SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETARGET CORPORATION22f59a88-02d7-ebdb-e063-6394a90a957b2024-09-25WarningsExact identifier
application number: M020
Target Up and Up SPF 50 Mineral Zinc Oxide Sunscreen StickZINC OXIDETARGET CORPORATION22f7c376-7289-04bf-e063-6394a90a14592024-09-25WarningsExact identifier
application number: M020
Target Up and Up SPF 50 Mineral Zinc Oxide SunscreenZINC OXIDETARGET CORPORATION22f86630-d4b4-8ad7-e063-6394a90a8d1e2024-09-25WarningsExact identifier
application number: M020
Target Up and Up SPF 50 Mineral Zinc Oxide SunscreenZINC OXIDETARGET CORPORATION22f9044a-f54c-b34b-e063-6394a90a88ee2024-09-25WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE,HOMOSALATE,OCTISALATE ,OCTOCRYLENEEdgewell Personal Care Brands LLC22e2b447-bd6b-5e8a-e063-6394a90a0de92024-09-24WarningsExact identifier
application number: M020
Luminous Defense SPF 50ZINC OXIDELevels 2 Skin22e177b3-beea-212e-e063-6394a90a14522024-09-24WarningsExact identifier
application number: M020
Target Up and Up SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETARGET CORPORATION22e359cd-4c63-b124-e063-6394a90aec732024-09-24WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61649-045-08616490045088.5 g in 1 CARTON (61649-045-08) 8.5 g2024-04-012028-01-16NoNoHistorical