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
Ingredient	Strength
ZINC OXIDE	20 g/100g

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2	Product name	5	20250304
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61649-045-08	ATTITUDE Oceanly Phyto-sun lip balm SPF 30 Baby Rose	8.5 g in 1 CARTON	STICK	8.5		2
61649-045-08	ATTITUDE Oceanly Phyto-Sun Kit SPF 30	8.5 g in 1 CARTON	STICK	8.5 g	20 g in 100g	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61649-045	ATTITUDE OCEANLY PHYTO-SUN KIT SPF 30 (ZINC OXIDE) KIT [9055-7588 QUEBEC INC. DBA ATTITUDE]	1	Current NDC	20240402_0eae4b71-60be-9715-e063-6294a90af463.zip
61649-045	ATTITUDE OCEANLY PHYTO-SUN LIP BALM SPF 30 BABY ROSE (ZINC OXIDE) STICK [9055-7588 QUEBEC INC. DBA ATTITUDE]	1	Current NDC, 1 package rows	20240402_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 279 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Kroger Dry Oil Tanning Sunscreen Broad Spectrum SPF 15 Reef Friendly	AVOBENZONE, HOMOSALATE, OCTISALATE, OXYBENZONE	THE KROGER COMPANY	c706aaf0-a978-7848-e053-2995a90a0aca	2024-10-15	Warnings	Exact identifier application number: M020
TopCare Everyday Ultimate Sheer Sun Broad Spectrum SPF 70	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	TOPCO ASSOCIATES LLC	c51029f4-ede0-08ef-e053-2995a90aecaf	2024-10-15	Warnings	Exact identifier application number: M020
TOPCARE EVERYDAY SPORT CONTINUOUS BROAD SPECTRUM SPF 30	AVOBENZONE, HOMOSALATE, OCTOCRYLENE,	TOPCO ASSOCIATES LLC	c8af028e-9d68-4023-e053-2995a90ad18a	2024-10-15	Warnings	Exact identifier application number: M020
TOPCARE EVERYDAY ULTRA PROTECTION SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	TOPCO ASSOCIATES LLC	c5601d22-2353-7319-e053-2a95a90a16c0	2024-10-15	Warnings	Exact identifier application number: M020
TOPCARE EVERYDAY CONTINUOUS BROAD SPECTRUM SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	TOPCO ASSOCIATES LLC	c8c12a5a-59f5-6515-e053-2995a90a58f7	2024-10-15	Warnings	Exact identifier application number: M020
Topcare Everyday Ultimate Sheer Sun Broad Spectrum SPF 55	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	TOPCO ASSOCIATES LLC	c6268778-8dcc-24b6-e053-2995a90acf03	2024-10-15	Warnings	Exact identifier application number: M020
TopCare Everyday Sport Sun SPF 50	AVOBENZONE, HOMOSALATE, OCTOCRYLENE	TOPCO ASSOCIATES LLC	f0de2999-f12b-89b1-e053-2a95a90ac610	2024-10-15	Warnings	Exact identifier application number: M020
TOPCO TOPCARE EVERYDAY MINERAL SUNSCREEN ZINC OXIDE SPF 50	ZINC OXIDE	TOPCO ASSOCIATES LLC	d501a94e-3bcd-d8e4-e053-2a95a90a33b0	2024-10-15	Warnings	Exact identifier application number: M020
TopCare Everyday Kids Mineral Sunscreen	ZINC OXIDE	TOPCO ASSOCIATES LLC	dbee42c8-9cae-7a81-e053-2a95a90a2329	2024-10-15	Warnings	Exact identifier application number: M020
TopCare Everyday Sport Sun Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	TOPCO ASSOCIATES LLC	f12c09b1-8ffe-4933-e053-2995a90a434f	2024-10-15	Warnings	Exact identifier application number: M020
TopCare Everyday Mineral Sunscreen Zinc Oxide SPF 30	ZINC OXIDE	TOPCO ASSOCIATES LLC	dbf03882-ab1a-9805-e053-2995a90a7109	2024-10-15	Warnings	Exact identifier application number: M020
TopCare Everyday Mineral Sunscreen Continuous Broad Spectrum SPF 50 Reef-Conscious Formula	TITANIUM DIOXIDE, ZINC OXIDE	TOPCO ASSOCIATES LLC	f14f43e6-ee57-5495-e053-2a95a90a4011	2024-10-15	Warnings	Exact identifier application number: M020
TopCare Everyday Sport Continuous Broad Spectrum SPF 70	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	TOPCO ASSOCIATES LLC	f31ea60e-1f52-c55f-e053-2a95a90afe64	2024-10-15	Warnings	Exact identifier application number: M020
Topco Topcare Everyday Mineral Sunscreen Continuous SPF 30	ZINC OXIDE	TOPCO ASSOCIATES LLC	f71e019b-392a-f8eb-e053-6394a90a871e	2024-10-15	Warnings	Exact identifier application number: M020
TOPCARE EVERYDAY SPORT SPF 70 SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	TOPCO ASSOCIATES LLC	a5b06600-f2b0-6d9b-e053-2995a90a59f0	2024-10-15	Warnings	Exact identifier application number: M020
TopCare Everyday Ultra Protection Sun SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	TOPCO ASSOCIATES LLC	f41d4c46-7998-afe6-e053-2995a90ab361	2024-10-15	Warnings	Exact identifier application number: M020
TOPCO TOPCARE EVERYDAY BABY PROTECTION SUN SPF 50	OCTISALATE, ZINC OXIDE	TOPCO ASSOCIATES LLC	f71c9060-3daf-e1be-e053-6294a90a4f91	2024-10-15	Warnings	Exact identifier application number: M020
MINERAL SUNSCREEN SPF 50	ZINC OXIDE, TITANIUM DIOXIDE	TOPCO ASSOCIATES LLC	bfe076fa-f21f-2c46-e053-2a95a90acee4	2024-10-15	Warnings	Exact identifier application number: M020
HEB SPF 50 Mineral Sunscreen Stick	ZINC OXIDE	H.E.B.	f58f0199-bf22-2197-e053-2995a90ae64f	2024-10-15	Warnings	Exact identifier application number: M020
HEB SPF 50 Kids Blue Mineral Sunscreen Stick Berry Scented	ZINC OXIDE	H.E.B.	f58d328c-8b30-b4d4-e053-2a95a90adb59	2024-10-15	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61649-045-08	61649004508	8.5 g in 1 CARTON (61649-045-08)	8.5 g	2024-04-01	2028-01-16	No	No	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ATTITUDE Oceanly Phyto-sun lip balm SPF 30 Baby Rose	9055-7588 Quebec Inc. DBA Attitude	2026-11-10	HUMAN OTC DRUG LABEL	3
ATTITUDE Oceanly Sun Kit SPF 30	9055-7588 Quebec Inc. DBA Attitude	2026-11-10	HUMAN OTC DRUG LABEL	3