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_41997acb-88d2-c8da-e063-6294a90ad450
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
Substance
ZINC OXIDE
Active strength
20 g/100g
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
ATTITUDE Oceanly Phyto-sun lip balm SPF 30 Baby Rose
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE20 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0e9d9419-a7e1-bc42-e063-6394a90af511Available on FDA.report

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 89 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EVERYRAY SUNCARE SUNSHINE SERUMEVERYRAY SUNCARE SUNSHINE SERUMGuangzhou Fantesy Biotechnology Co.,Ltd062be336-2af4-10e2-e063-6294a90a480a2026-01-05WarningsExact identifier
application number: M020
sunscreen powderSUNSCREEN POWDERGuangzhou Fantesy Biotechnology Co.,Ltdfae8ecaf-7a9c-902b-e053-6394a90a5f312026-01-05WarningsExact identifier
application number: M020
ORLASKIN HYDRATING SUNSCREENORLASKIN HYDRATING SUNSCREENGuangzhou Fantesy Biotechnology Co.,Ltd0808b0cd-2cfb-8554-e063-6294a90ad6c42026-01-05WarningsExact identifier
application number: M020
DALLAS JAMES SKINCARE CO. SPF 50 SunscreenDALLAS JAMES SKINCARE CO. SPF 50 SUNSCREENGuangzhou Fantesy Biotechnology Co.,Ltd225faeec-4f96-e082-e063-6394a90a9a312026-01-05WarningsExact identifier
application number: M020
LING NEW YORK Save Face Broad Spectrum SPF 30LING NEW YORK SAVE FACE BROAD SPECTRUM SPF 30Guangzhou Fantesy Biotechnology Co.,Ltd1dfa80bd-495a-18fb-e063-6394a90a4d0d2026-01-05WarningsExact identifier
application number: M020
Sky and Sol Sunscreen SPF30SKY AND SOL SUNSCREEN SPF30Guangzhou Fantesy Biotechnology Co.,Ltd1d917329-dea2-e792-e063-6294a90a0a0d2026-01-05WarningsExact identifier
application number: M020
Sky and Sol Sunscreen SPF50SKY AND SOL SUNSCREEN SPF50Guangzhou Fantesy Biotechnology Co.,Ltd1c699b06-c156-b0da-e063-6294a90a947d2026-01-05WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC228fab45-e0d2-f219-e063-6294a90a1ef62026-01-05WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC228055ec-ff59-4412-e063-6394a90abe142026-01-05WarningsExact identifier
application number: M020
SHISEIDO UV PROTECTIVE FOUNDATION FAIR IVORYOCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATION236bdb53-d7a5-43a2-8a0c-bce4a5522e262026-01-05WarningsExact identifier
application number: M020
SHISEIDO BENEFIANCE WRINKLE SMOOTHING DAYAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONESHISEIDO AMERICAS CORPORATION4bd99626-690b-49e8-8c42-a2e2dbca09bf2026-01-05WarningsExact identifier
application number: M020
cle de peau BEAUTE LONG-LASTING HYDRATING VEILAVOBENZONE, OCTINOXATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATIONf04ece6c-66b6-48e9-8f6b-e898a538ba002026-01-05WarningsExact identifier
application number: M020
cle de peau BEAUTE RADIANT FOUNDATION N I10OCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATION05ffb157-5e28-4e94-866d-9e3371480d842026-01-05WarningsExact identifier
application number: M020
cle de peau BEAUTE CONCEALER N 1TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONeedf8065-8897-4773-9cbb-bab57d2dd04f2026-01-05WarningsExact identifier
application number: M020
cle de peau BEAUTE BRIGHTENING ENHANCER VEILOCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONbb00d6d7-cc51-4fee-a0df-68bbd5bc50d62026-01-05WarningsExact identifier
application number: M020
cle de peau BEAUTE THE FOUNDATION N I10 VERY LIGHT IVORYOCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONbeefe840-6f32-483b-8a37-2696adb8eea12026-01-05WarningsExact identifier
application number: M020
cle de peau BEAUTE PROTECTIVE LIP TREATMENT SPF 25AVOBENZONE, OCTINOXATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATIONaddd9885-362c-4ce0-9a6e-759e71d8756c2026-01-05WarningsExact identifier
application number: M020
cle de peau BEAUTE PROTECTIVE FORTIFYING nAVOBENZONE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONESHISEIDO AMERICAS CORPORATION65ca1240-6ee8-40c0-b62f-3597e0872c6e2026-01-05WarningsExact identifier
application number: M020
cle de peau BEAUTE CORRECTING VEIL n MENSULIZOLE, OCTINOXATE, AND ZINC OXIDESHISEIDO AMERICAS CORPORATION15a258a0-61c3-4419-bcdb-a8197d5ae46f2026-01-05WarningsExact identifier
application number: M020
Dominas Dark Spot UV Defense Sunscreen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELG H&H Co.,Ltd.098c0a9b-2b96-6be3-e063-6294a90a959a2026-01-05WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
61649-045-08616490045088.5 g in 1 CARTON (61649-045-08) 8.5 g2024-04-01NoNoCurrent