SunStation USA SPF-30 SPORT SUNSCREEN

Product NDC: 76348-407
11-digit product format: 763480407
Labeler code: 76348
Product ID: 76348-407_2d043dd6-9aef-2b7e-e063-6294a90aec69
Type: HUMAN OTC DRUG
Nonproprietary name: ZINC OXIDE
Dosage form: LOTION
Route: TOPICAL
Labeler: RENU LABORATORIES, LLC
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2024-02-20
Substance: OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE
Active strength: 63; 9; 11.2; 11.2 g/896g; g/896g; g/896g; g/896g
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: SunStation USA SPF-30 SPORT SUNSCREEN
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OCTINOXATE	63 g/896g
OCTISALATE	9 g/896g
TITANIUM DIOXIDE	11.2 g/896g
ZINC OXIDE	11.2 g/896g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4Y5P7MUD51	Internal UNII lookup
4X49Y0596W	Internal UNII lookup
15FIX9V2JP	Internal UNII lookup
SOI2LOH54Z	Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
11d3c60e-238d-999e-e063-6394a90a624b	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76348-407-01	SunStation USA SPF-30 SPORT SUNSCREEN	896 g in 1 CONTAINER	LOTION	896		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76348-407	SUNSTATION USA SPF-30 SPORT SUNSCREEN (ZINC OXIDE) LOTION [RENU LABORATORIES, LLC]	2	Current NDC, 1 package rows	20250427_11d3c60e-238d-999e-e063-6394a90a624b.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 304 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BB Tint 30 BS SPF 30	ZINC OXIDE AND TITANIUM DIOXIDE	Allure Labs	1212448c-db88-26e6-e063-6294a90a3b9e	2024-02-23	Warnings	Exact identifier application number: M020
Daily Prevention Pure Mineral Hydrating Moisturizer SPF30	ZINC OXIDE	Allure Labs	11fce5ec-66e8-9eac-e063-6394a90aaf3a	2024-02-22	Warnings	Exact identifier application number: M020
CLARINS UV PLUS ANTI-POLLUTION SUNSCREEN MULTI-PROTECTION BROAD SPECTRUM SPF 50 Oil-Free -DEEP	HOMOSALATE,OCTOCRYLENE,OXYBENZONE,TITANIUM DIOXIDE	Laboratoires Clarins	bf31d19d-9520-4ac0-a4fd-2c285545f1b8	2024-02-20	Warnings	Exact identifier application number: M020
Clarins UV PLUS ANTI-POLLUTION B.S. SPF 50, Sunscreen Multi-Protection Tint Medium	HOMOSALATE,OCTOCRYLENE,OXYBENZONE,TITANIUM DIOXIDE	Laboratoires Clarins	2c0964cd-607c-4219-b66e-cc99ada80434	2024-02-20	Warnings	Exact identifier application number: M020
CLARINS UV PLUS ANTI-POLLUTION SUNSCREEN MULTI-PROTECTION BROAD SPECTRUM SPF 50 Oil-Free -LIGHT	HOMOSALATE,OCTOCRYLENE,OXYBENZONE,TITANIUM DIOXIDE	Laboratoires Clarins	6259442e-0c39-4887-8083-89253b64b5ff	2024-02-20	Warnings	Exact identifier application number: M020
Meijer SPF 30 Sunscreen	AVOBENZONE 3%, HOMOSALATE 15%, OCSTISALATE 5%, OCTOCRYLENE 6%	Meijer	074b6340-0482-ab05-e063-6294a90adedb	2024-02-19	Warnings	Exact identifier application number: M020
GANGNAM Glow Day Shield Perfect Sunscreen SPF 50	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	LG H&H Co., Ltd.	11c37acc-abb8-8c38-e063-6294a90a7932	2024-02-19	Warnings	Exact identifier application number: M020
GANGNAM Glow Day Shield Perfect Sunscreen SPF 50	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	fmg Co.Ltd	11c461f7-0f34-65ff-e063-6294a90a3da7	2024-02-19	Warnings	Exact identifier application number: M020
belif The true cream aqua bomb sunscreen Broad Spectrum SPF 45	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	LG H&H Co.,Ltd.	11c61b92-89f4-692f-e063-6394a90a69cd	2024-02-19	Warnings	Exact identifier application number: M020
belif The true cream aqua bomb sunscreen Broad Spectrum SPF 45	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	fmg Co.Ltd	11c651e2-072e-770e-e063-6394a90ad6fa	2024-02-19	Warnings	Exact identifier application number: M020
belif The true cream aqua bomb sunscreen Broad Spectrum SPF 45	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	LG H&H Co.,Ltd.	11c65e7f-fe11-8115-e063-6394a90a8594	2024-02-19	Warnings	Exact identifier application number: M020
belif The true cream aqua bomb sunscreen Broad Spectrum SPF 45	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	fmg Co.Ltd	11c6cf95-8923-af79-e063-6294a90a4f44	2024-02-19	Warnings	Exact identifier application number: M020
CNP Laboratory Sun Care Milky Light Sunscreen Broad Spectrum SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	LG H&H Co.,Ltd.	118842ce-9d9b-80ce-e063-6394a90ab986	2024-02-16	Warnings	Exact identifier application number: M020
CNP Laboratory Sun Care Milky Light Sunscreen Broad Spectrum SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	fmg Co.Ltd	11894c1d-c199-dfc0-e063-6394a90a3f15	2024-02-16	Warnings	Exact identifier application number: M020
Atomy Sunscreen Beige Broad Spectrum SPF 50 PLUS	HOMOSALATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	ATOMY CO., LTD.	711aa92c-81b0-42e4-b83f-9ce95116ec03	2024-02-16	Warnings	Exact identifier application number: M020
Atomy Sunscreen White Broad Spectrum SPF 50 PLUS	HOMOSALATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	ATOMY CO., LTD.	b8bc0021-bb4d-45f2-a570-3f2e61edf21d	2024-02-16	Warnings	Exact identifier application number: M020
Meijer SPF 50 Sunscreen	AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 10%	Meijer	075dddd5-46ea-282a-e063-6294a90a28fd	2024-02-15	Warnings	Exact identifier application number: M020
Sheet SPF 30 Mineral	TITANIUM DIOXIDE, ZINC OXIDE	Vivier Pharma Inc.	bbb5b87c-d641-3ba2-e053-2a95a90a0f70	2024-02-14	Warnings	Exact identifier application number: M020
sheer tint SPF 45	BROAD SPECTRUM	CP Skin Health Group, Inc.	b7c5cedd-ff68-74de-e053-2a95a90a3796	2024-02-14	Warnings	Exact identifier application number: M020
Weightless Protection SPF 45	SUNSCREEN BROAD SPECTRUM	CP Skin Health Group, Inc.	b6bee26d-bffd-a8ee-e053-2a95a90affc5	2024-02-14	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE
15FIX9V2JP	TITANIUM DIOXIDE	13463-67-7	TITANIUM DIOXIDE
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	Sample	Exclude flag	Status
76348-407-01	76348040701	896 g in 1 CONTAINER (76348-407-01)	896 g	2024-02-20	No	No	Current