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 259 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mentholatum Medicated Lip Balm Original	DIMETHICONE, OCTINOXATE, OCTISALATE	The Mentholatum Company	f84cc3a4-cc9f-4a38-8b7d-cf8d6cd39df1	2024-12-17	Warnings	Exact identifier application number: M020
Mentholatum Natural Ice Sport SPF 30	AVOBENZONE, DIMETHICONE, OCTINOXATE, OCTISALATE	The Mentholatum Company	57c35631-42d3-4c6c-bcbb-e2de92b45b13	2024-12-17	Warnings	Exact identifier application number: M020
Mary Kay TimeWise Repair Volu-Firm Day Cream Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	Mary Kay Inc.	5f09503e-c455-4ac2-8d07-e8e66c2daa32	2024-12-17	Warnings	Exact identifier application number: M020
Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Light to Medium	HOMOSALATE, OCTINOXATE, OXYBENZONE	Mary Kay Inc.	b5ca4bed-4f89-4020-a055-9d11f4cd5058	2024-12-17	Warnings	Exact identifier application number: M020
Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Deep	HOMOSALATE, OCTINOXATE, OXYBENZONE	Mary Kay Inc.	e5fffd20-1d22-485a-9311-4cb4f9264f6f	2024-12-17	Warnings	Exact identifier application number: M020
Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Very Deep	HOMOSALATE, OCTINOXATE, OXYBENZONE	Mary Kay Inc.	404990e4-9499-4186-b39d-afc31834d334	2024-12-17	Warnings	Exact identifier application number: M020
Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Medium to Deep	HOMOSALATE, OCTINOXATE, OXYBENZONE	Mary Kay Inc.	6028e210-a8a3-4d84-a462-16a414c31052	2024-12-17	Warnings	Exact identifier application number: M020
Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Very Light	HOMOSALATE, OCTINOXATE, OXYBENZONE	Mary Kay Inc.	af22b3a5-ac72-4c2a-aa7e-6b5ca07d89e8	2024-12-17	Warnings	Exact identifier application number: M020
Mary Kay TimeWise Daytime Defender Sunscreen Broad Spectrum SPF 30	AVOBENZONE/OCTISALATE/OCTOCRYLENE	Mary Kay Inc.	00f0f30d-236a-fd45-e063-6294a90a747d	2024-12-17	Warnings	Exact identifier application number: M020
Softlips Cherry Cordial, Maple Butter, Frosted Berry	DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE	The Mentholatum Company	bab8447b-58b8-4160-a91e-05f9fd09ed1d	2024-12-17	Warnings	Exact identifier application number: M020
STUDIO FIX FLUID BROAD SPECTRUM SPF 15	OCTINOXATE, TITANIUM DIOXIDE	MAKEUP ART COSMETICS	fb59afc1-1dc9-f783-e053-6394a90a196b	2024-12-17	Warnings	Exact identifier application number: M020
Mary Kay Mineral Facial Sunscreen Broad Spectrum SPF30	ZINC OXIDE	Mary Kay Inc.	0e9b15e4-e59c-f266-e063-6394a90ab81c	2024-12-17	Warnings	Exact identifier application number: M020
MAC STUDIO WATERWEIGHT SPF 30 BROAD SPECTRUM FOUNDATION SUNSCREEN	OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDE	MAKEUP ART COSMETICS	e5fd3e40-de1d-4cdd-b725-4a517514ca35	2024-12-17	Warnings	Exact identifier application number: M020
STUDIO FINISH CONCEALER BROAD SPECTRUM SPF 35	OCTINOXATE AND TITANIUM DIOXIDE	MAKEUP ART COSMETICS	2d034810-7210-4ad4-be23-ec2100f8c2f1	2024-12-17	Warnings	Exact identifier application number: M020
Aruba Aloe Hydrating Aloe Rich Sunscreen SPF 50	AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE	Aruba Aloe Balm NV	acda1640-0d35-43dc-8734-d47b00cc85ed	2024-12-17	Warnings	Exact identifier application number: M020
Mary Kay Foundation Primer	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Mary Kay Inc.	59d25b44-1adb-4790-8ce6-2d847a06b8b3	2024-12-17	Warnings	Exact identifier application number: M020
Mary Kay TimeWise Repair Volu-Firm The Go Set	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE	Mary Kay Inc.	cf7fb8f0-483d-443b-b381-086a255f0783	2024-12-17	Warnings	Exact identifier application number: M020
Mary Kay TimeWise Repair Volu-Firm Sampler Set	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE	Mary Kay Inc.	0a9ee359-19c1-4266-8a51-a68f655de151	2024-12-17	Warnings	Exact identifier application number: M020
Mary Kay TimeWise Repair Volu-Firm Set	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE	Mary Kay Inc.	d459e2f7-dc78-4519-9733-01495fc447a2	2024-12-17	Warnings	Exact identifier application number: M020
Babo Botanicals Daily Sheer Tinted Mineral Sunscreen SPF 50	ZINC OXIDE	Babo Botanicals, Inc.	2982ce67-f136-b93b-e063-6394a90a81ac	2024-12-17	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