SunStation USA SPF-30 SPORT SUNSCREEN

Product NDC: 76348-407
Requested package NDC: 76348-407-01
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 108 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Avail Facial Sunscreen SPF 25	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	Emeis Cosmetics Pty Ltd	7be903e4-5f07-35b2-e053-2991aa0a1340	2025-12-17	Warnings	Exact identifier application number: M020
Mineral Sheer Stick	ZINC OXIDE	Supergoop, LLC	0beed72e-51df-d15a-e063-6394a90af559	2025-12-17	Warnings	Exact identifier application number: M020
Sunscreen Lotion118ml	ZINC OXIDE 12%,TITANIUM DIOXIDE 6%, HOMOSALATE 14%,OCTISALATE 5%	Foshan Sugar Max Cosmetics CO.,Ltd	4620c41a-2188-00f5-e063-6394a90a613c	2025-12-17	Warnings	Exact identifier application number: M020
Sunscreen Cream	ZINC OXIDE 15%,TITANIUM DIOXIDE 6%,HOMOSALATE 5%,OCTISALATE 4%	Foshan Sugar Max Cosmetics CO.,Ltd	46224dbe-a0fb-c242-e063-6394a90a2634	2025-12-17	Warnings	Exact identifier application number: M020
CAPTURE TOTALE C.E.L.L. ENERGY SUPER POTENT SERUM FOUNDATION BROAD SPECTRUM SPF 20 0N	ENSULIZOLE, OCTISALATE	Parfums Christian Dior	31141a45-54e2-4463-ab42-4df56d911650	2025-12-17	Warnings	Exact identifier application number: M020
Perricone High Potency Face Finishing and Firming Moisturizer	TITANIUM DIOXIDE, ZINC OXIDE	THG Beauty USA LLC	2409cea1-7077-dc12-e063-6294a90a4558	2025-12-17	Warnings	Exact identifier application number: M020
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Glow Advanced Skin and Body Care, LLC	3635a073-5484-f96c-e063-6394a90adef5	2025-12-17		Exact identifier application number: M020
Mineral Sunscreen Lip	TITANIUM DIOXIDE, ZINC OXIDE	Glow Advanced Skin and Body Care, LLC	36362dc7-31d7-f766-e063-6294a90a129b	2025-12-17		Exact identifier application number: M020
Mineral Sunscreen Non-Tinted	ZINC OXIDE	Glow Advanced Skin and Body Care, LLC	3635e45b-6978-ac69-e063-6294a90a22ac	2025-12-17		Exact identifier application number: M020
Prime and Protect	TITANIUM DIOXIDE, ZINC OXIDE	Shannon Cornelsen-Lewandowski	36480f7f-37e8-decd-e063-6394a90ada60	2025-12-17		Exact identifier application number: M020
Prime and Protect	TITANIUM DIOXIDE, ZINC OXIDE	Shannon Cornelsen-Lewandowski	364827bd-5781-eb53-e063-6394a90ab22f	2025-12-17		Exact identifier application number: M020
non-tinted face mineral sunscreen SPF40	TITANIUM DIOXIDE, ZINC OXIDE	Lisa Nadler Skin Care and Waxing	3649bf1a-17c3-fe0b-e063-6294a90a13c0	2025-12-17		Exact identifier application number: M020
Tinted Mattifying Face Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Lisa Nadler Skin Care and Waxing	3649f634-8bcd-b3c1-e063-6394a90a49d9	2025-12-17		Exact identifier application number: M020
tinted face and body mineral sunscreen SPF40	ZINC OXIDE	Lisa Nadler Skin Care and Waxing	364a1edd-56e1-55f0-e063-6294a90a45a6	2025-12-17		Exact identifier application number: M020
non-tinted face and body mineral sunscreen SPF40	ZINC OXIDE	Lisa Nadler Skin Care and Waxing	364a8c8d-df84-e568-e063-6394a90aaff1	2025-12-17		Exact identifier application number: M020
tinted lip mineral sunscreen SPF45	TITANIUM DIOXIDE, ZINC OXIDE	Lisa Nadler Skin Care and Waxing	364b023b-4a52-225a-e063-6394a90ad197	2025-12-17		Exact identifier application number: M020
ULTAMATTE PROTECTION SUNSCREEN	TITANIUM DIOXIDE, ZINC OXIDE	SKINFINITY	37efc466-17b8-9f7b-e063-6294a90a8c88	2025-12-17		Exact identifier application number: M020
ULTRA SILK PROTECTION SUNSCREEN	ZINC OXIDE	SKINFINITY	383ea760-d55e-a32a-e063-6294a90aa3d2	2025-12-17		Exact identifier application number: M020
Bella Blu Skin Care Non Tinted Sunscreen	ZINC OXIDE	BELLA BLU STUDIOS INC	3f67134c-88e8-8513-e063-6294a90aaf5a	2025-12-17	Warnings	Exact identifier application number: M020
Bella Blu Skin Care Non Tinted Sunscreen	ZINC OXIDE	BELLA BLU STUDIOS INC	3f66d2ae-00e7-608c-e063-6294a90a49c6	2025-12-17	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