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 262 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Babo SPF 30 Clear Zinc Fragrance Free	MINERAL SUNSCREEN	Babo Botanicals, Inc.	b3e40cb0-dbfd-955c-e053-2995a90af848	2024-12-12	Warnings	Exact identifier application number: M020
DOCTOR BABOR SOLAR DEFENSE MINERAL SUNSCREEN BROAD SPECTRUM SPF 30	ZINC OXIDE	BABOR Cosmetics America Corp	291ec801-ee15-06a4-e063-6294a90ab32b	2024-12-12	Warnings	Exact identifier application number: M020
All Calm Clinical Redness Corrector SPF 50	TITANIUM DIOXIDE AND ZINC OXIDE	Colorescience	68b95e94-3686-4d11-9952-ec86394376ee	2024-12-12	Warnings	Exact identifier application number: M020
Method Men Face with Zinc Oxide Sunscreen	ZINC OXIDE	Method Products Inc.	cce5f8e1-cf40-4524-af2b-1d49309e2809	2024-12-12	Warnings	Exact identifier application number: M020
Sunforgettable Tint du Soleil Foundation SPF 30 Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	Colorescience	219e2ef4-e977-4527-8999-14b27d5a7a33	2024-12-12	Warnings	Exact identifier application number: M020
Absolutely Natural Broad Spectrum SPF 50Plus Sunscreen	ZINC OXIDE	Absolutely Natural	4855c2c7-1516-4857-b103-2eb72a60d5d0	2024-12-11	Warnings	Exact identifier application number: M020
Absolutely Natural Broad Spectrum SPF 30 Sunscreen	ZINC OXIDE	Absolutely Natural	b6e8f361-fd31-4f21-9095-c5159a826175	2024-12-11	Warnings	Exact identifier application number: M020
Walgreens Scar Cream w/SPF 30	AVOBENZONE3%,OCTOCRYLENE10%,OXYBENONE 6%	Walgreens	cc72c8c5-f3e9-e8e0-e053-2a95a90ae0b0	2024-12-11	Warnings	Exact identifier application number: M020
ERBORIAN - BB CREME AU GINSENG CLAIR SPF 20	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	LABORATOIRES M&L	ee9ae84b-c8fc-4a87-8910-46ec8ccfe1a9	2024-12-11	Warnings	Exact identifier application number: M020
ERBORIAN - BB CREME AU GINSENG DORE SPF 20	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	LABORATOIRES M&L	121aa873-5ca6-426b-8ece-dcb5a9f82a03	2024-12-11	Warnings	Exact identifier application number: M020
ERBORIAN - CC CREME HIGH DEFINITION SPF 25	OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	LABORATOIRES M&L	3421b9a3-6551-406f-af3a-b3da8a01d2b2	2024-12-11	Warnings	Exact identifier application number: M020
ERBORIAN CC RED CORRECT SPF 25	OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	Laboratoires M&L	21530925-03b7-40bb-9836-6ee4011c4a79	2024-12-11	Warnings	Exact identifier application number: M020
ERBORIAN CC CREME HIGH DEFINITION SPF 25 CARAMEL	OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	LABORATOIRES M&L	70a5537c-a364-4dae-8ab2-8ca0cbfd11b7	2024-12-11	Warnings	Exact identifier application number: M020
ERBORIAN - CC CREME HIGH DEFINITION SPF25 CLAIR	OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	LABORATOIRES M&L	b55be8cb-7f21-45b0-bb8f-a60182077ca3	2024-12-11	Warnings	Exact identifier application number: M020
I Conceal Flawless Foundation Broad Spectrum SPF 30 Sunscreen Deep Honey	ZINC OXIDE AND TITANIUM DIOXIDE	Allure Labs	dc792777-d8b6-3ebc-e053-2a95a90abc3f	2024-12-11	Warnings	Exact identifier application number: M020
Zoey naturals Broad Spectrum SPF 50 Fragrance Free Sunscreen	ZINC OXIDE	Absolutely Natural	6e05e060-a531-4c4a-b273-889407ec5704	2024-12-11	Warnings	Exact identifier application number: M020
Peptide Lip Shine SPF30 Sunscreen	ZINC OXIDE	Colorescience, Inc.	98cdf19d-8b8a-4051-88bb-79160b2af39e	2024-12-11	Warnings	Exact identifier application number: M020
Zoey naturals Broad Spectrum SPF 50Plus Fragrance Free Sunscreen	ZINC OXIDE	Absolutely Natural	082983a4-7b98-489d-8ac2-a185923b86ba	2024-12-11	Warnings	Exact identifier application number: M020
Absolutely Natural Broad Spectrum SPF 50 Sunscreen	ZINC OXIDE	Absolutely Natural	89657538-904d-4908-ba7b-6f84706a8001	2024-12-11	Warnings	Exact identifier application number: M020
SISLEYA Global Anti-Age Hand care SPF 15	AVOBENZONE, OCTINOXATE, OCTISALATE	C.F.E.B. Sisley	cddf11b1-a89b-4b54-b228-55ba8147f022	2024-12-10	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