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 326 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 3W	OCTISALATE, TITANIUM DIOXIDE	Guerlain	15fe0429-720c-4975-953d-285aa7ee12ce	2023-11-08	Warnings	Exact identifier application number: M020
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 4W	OCTISALATE, TITANIUM DIOXIDE	Guerlain	1a733548-75a4-41ec-8d8d-3e6e9aad52e0	2023-11-08	Warnings	Exact identifier application number: M020
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 8N	OCTISALATE, TITANIUM DIOXIDE	Guerlain	f43c867a-161f-47b7-b3d8-7f7e6c672804	2023-11-08	Warnings	Exact identifier application number: M020
Aruba Sun SPF 70 Sunscreen	AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%	Derma Care Research Labs, LLC	d96b4233-6d52-7621-e053-2a95a90a1b60	2023-11-08	Warnings	Exact identifier application number: M020
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 0C	OCTISALATE, TITANIUM DIOXIDE	Guerlain	0d75be99-7607-4964-bb6e-3c731644ab4e	2023-11-08	Warnings	Exact identifier application number: M020
Dead Sea Natural Face Moisturizer Broad Spectrum SPF 20	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	AHAVA Dead Sea Laboratories Ltd	dee4bdb8-5c6f-42f6-b15c-d109cd2d3140	2023-11-08	Warnings	Exact identifier application number: M020
Mineral Radiance Energizing Day BS SPF 15	AVOBENZONE, HOMOSALATE, AND OCTISALATE	AHAVA Dead Sea Laboratories Ltd	4cb8b21c-7727-441a-9d61-c90d79ac45dc	2023-11-08	Warnings	Exact identifier application number: M020
Jack Black Intense Therapy Lip Balm Passion Fruit	AVOBENZONE, OCTINOXATE LIP BALM SUNSCREEN	Jack Black, LLC	f34beb68-e5dc-45c4-a6d1-e9a031016228	2023-11-08	Warnings	Exact identifier application number: M020
Private Label SPF45 Water Resistant Paraben Free Sunscreen	OCTINOXATE, OCTISALATE, ZINC OXIDE SUNSCREEN	Swiss-American CDMO, LLC	f997f4fc-7da5-433c-9a53-2030b489b4f6	2023-11-07	Warnings	Exact identifier application number: M020
Private Label Moisturizing Oil Free Paraben Free SPF43	SUNSCREEN	Swiss-American CDMO, LLC	003e4221-f9d9-47c4-b10b-9876046b931a	2023-11-07	Warnings	Exact identifier application number: M020
AHAVA ACTIVE DEADSEA MINERALS TIME TO ENERGIZE AGE CONTROL MOISTURIZING BROAD SPECTRUM SPF15	AVOBENZONE, OCTISALATE, AND OCTOCRYLENE	AHAVA Dead Sea Laboratories Ltd	5a9ec221-a9ec-4473-8fb0-83f10ae775e2	2023-11-07	Warnings	Exact identifier application number: M020
Private Label Super Light Oil-Free SPF45	2.75% OCTINSALATE, 7.50% OCTINOXATE, 8.00% ZINC OXIDE SUNSCREEN	Swiss-American CDMO, LLC	6a08448a-46bc-4330-ae2d-f716bb4edfa7	2023-11-07	Warnings	Exact identifier application number: M020
GOLD MOUNTAIN BEAUTY Collagen Broad Spectrum SPF 30	OCTINOXATE, OCTISALATE, ZINC OXIDE	TT Fitness, Inc	617ef3af-4203-4664-b714-1b5fab2e0ee6	2023-11-06	Warnings	Exact identifier application number: M020
SEAWEED BATH CO. Clear Moisture Mineral SPF-30	ZINC OXIDE	The Seaweed Bath Co.	c241261c-d887-4ac2-89ce-93dcc0fce267	2023-11-06	Warnings	Exact identifier application number: M020
JESS BEAUTY Let It Sun Sunscreen SPF-50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	JESS BEAUTY PRODUCTS LLC	88628c11-dbc7-4404-9701-7944a685a13d	2023-11-06	Warnings	Exact identifier application number: M020
SEAWEED BATH CO. Sheer Mineral Sensitive SPF-50	ZINC OXIDE	The Seaweed Bath Co.	fdcfc7eb-da33-4461-a4f9-fe97ea6b873f	2023-11-06	Warnings	Exact identifier application number: M020
SANTO REMEDIOS Piel Eterna Radiance Sunscreen Primer SPF-42	TITANIUM DIOXIDE, ZINC OXIDE	SANTO REMEDIO LLC	82d210bc-b7ca-4d74-be58-85f175a75058	2023-11-06	Warnings	Exact identifier application number: M020
CALIFORNIA MANGO SPF-50 SUNSCREEN	AVOBENZONE, OCTISALATE, OCTOCRYLENE	CALMANGO, INC	183e523a-93ee-47ec-8bd4-5557af449ea5	2023-11-06	Warnings	Exact identifier application number: M020
Mineral Sunscreen SPF-30	TITANIUM DIOXIDE, ZINC OXIDE	NEWCO LLC	fa3c73a3-0dfb-4673-822a-45d946dee260	2023-11-06	Warnings	Exact identifier application number: M020
JESS BEAUTY Sun Drops Sunscreen Oil SPF-50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	JESS BEAUTY PRODUCTS LLC	4e05e9d6-5127-44ca-a331-3004b2ddb534	2023-11-06	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