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 323 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DERMAKA Broad Spectrum SPF-42 Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	DERMAKA SKIN PRODUCTS	32b892fd-c68f-4670-bbaa-0b3de5712849	2023-11-11	Warnings	Exact identifier application number: M020
WILMA SCHUMANN Moisture Protektiv Day Cream SPF-20	OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE	SKINMETICS INC	4a719986-d1d0-4156-b803-04004b721504	2023-11-11	Warnings	Exact identifier application number: M020
DERMAKA Broad Spectrum SPF-42 Sunscreen Untinted	TITANIUM DIOXIDE, ZINC OXIDE	DERMAKA SKIN PRODUCTS	9aa24e1f-e338-4947-a437-554fb6b227a2	2023-11-11	Warnings	Exact identifier application number: M020
TIGER BABY Baby Sunscreen SPF-50	ZINC OXIDE	BRICKELL BRANDS LLC	f2aa0e03-e8b6-42d0-8fa0-2e96ca486b5c	2023-11-11	Warnings	Exact identifier application number: M020
Brickell Mens Products Daily Defense Face Moisturizer SPF-20	OCTISALATE, ZINC OXIDE	BRICKELL BRANDS LLC	a61e20e4-d5c9-4dc4-a18a-cc88b358d15c	2023-11-11	Warnings	Exact identifier application number: M020
EIGHT SAINTS Chase The Sun SPF-30	OCTOCRYLENE, OCTISALATE, ZINC OXIDE	BRICKELL BRANDS LLC	9b19b2b4-d8b9-415d-a217-4a5ef3d75a8c	2023-11-11	Warnings	Exact identifier application number: M020
LUCKY 13s ALL NATURAL TATTOO SUNSCREEN SPF-30	ZINC OXIDE	SALES BRAIN HOLDINGS LLC	ec06bc4b-90d6-4b41-9086-f57737a34d91	2023-11-11	Warnings	Exact identifier application number: M020
TRENDY JOHN SPF-32 Sheer Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	TRENDY JOHN LLC	80dccecb-fbb3-4af6-9cb4-6acea733e996	2023-11-11	Warnings	Exact identifier application number: M020
CARIBBEAN SOL Natural Sunscreen SPF-30	ZINC OXIDE	Caribbean Sol International, LLC	19117321-c37b-4b37-9bd6-7c5c973e2f31	2023-11-11	Warnings	Exact identifier application number: M020
MIAMI BEACH BUM Blocked SPF-30 Sunscreen	ZINC OXIDE	MIAMI BEACH BUM	669443a1-7b54-454f-b22f-8cfa9df38bbb	2023-11-11	Warnings	Exact identifier application number: M020
STRYX Daily Moisturizer SPF-30	OCTISALATE, ENSULIZOLE	STRYX MEN, INC.	2bac4348-5b5d-41cc-893e-b9d5c1215ab0	2023-11-11	Warnings	Exact identifier application number: M020
SIMPLI DAY All In One SmartCream SPF 42	ZINC OXIDE, OCTISALATE, OCTOCRYLENE, ENSULIZOLE	SIMPLI SKIN MD LLC	e5aab0ec-eda2-4073-998a-966202dc2233	2023-11-11	Warnings	Exact identifier application number: M020
HAWAIIAN SOL Natural Sunscreen SPF-30	ZINC OXIDE	Caribbean Sol International, LLC	3c43fe36-2c24-4859-a262-8af4d3420e47	2023-11-11	Warnings	Exact identifier application number: M020
JOYSPRING Kids Mineral Sunscreen SPF-30	ZINC OXIDE	JOYSPRING HOLDINGS LLC	3ca50033-5bcb-4a6d-8aba-a797c5b8d0e9	2023-11-11	Warnings	Exact identifier application number: M020
TANCEUTICALS SPF DROPS Broad Spectrum SPF-30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	TANCEUTICALS, LLC	8640b971-7c99-4c8f-ac5c-ecdd88b99fe0	2023-11-11	Warnings	Exact identifier application number: M020
PROTEKT SPF-50 Sheer Mineral Sunscreen	ZINC OXIDE	Protekt Products, Inc.	806b4e40-0e02-424b-80e7-026a211b4dfe	2023-11-11	Warnings	Exact identifier application number: M020
KOVR All-Natural SPF-30 Moisturizing Sunscreen for Women	TITANIUM DIOXIDE, ZINC OXIDE	ACTIVE LIFE INC	0ddc3bb9-595e-4ebd-ad3e-df4d94fd34ed	2023-11-11	Warnings	Exact identifier application number: M020
Personalized Day Moisturizer with SPF 50	ZINC OXIDE	Proven Skincare	bb921e91-9faf-4210-9091-ab511af9012a	2023-11-10	Warnings	Exact identifier application number: M020
Personalized Day Moisturizer with SPF	ZINC OXIDE	Proven Skincare	f4d682bc-825f-494c-8528-3d328dc63994	2023-11-10	Warnings	Exact identifier application number: M020
Ultra Replenishing Sunscreen SPF 40	HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXYIDE CREAM	CosMedical Technologies, LLC	92ad5d7a-9adb-7d55-e053-2995a90a80e7	2023-11-10	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