Surfers Skin Sunscreen

Product NDC: 75916-4019
11-digit product format: 759164019
Labeler code: 75916
Product ID: 75916-4019_1bcab3f2-a9fd-4f3a-8f34-528b3223b54c
Type: HUMAN OTC DRUG
Nonproprietary name: OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE
Dosage form: CREAM
Route: TOPICAL
Labeler: Skin Alive, Ltd.
Application: part352
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2011-01-31
Marketing end: 0000-00-00
Substance: OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE; ZINC OXIDE
Active strength: 8 mL/100mL; mL/100mL; mL/100mL; mL/100mL
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	75916-4019		I	Inactivated by FDA	2026-10-23
excluded package	package	75916-4019	75916-4019-1	I	Inactivated by FDA	2026-10-23
excluded package	package	75916-4019	75916-4019-4	I	Inactivated by FDA	2026-10-23

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 2 · 66 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	75916-4019-4	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	75916-4019-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	75916-4019-4	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	75916-4019-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	75916-4019-4	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	75916-4019-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	75916-4019-4	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	75916-4019-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	75916-4019-4	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	75916-4019-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	75916-4019-4	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	75916-4019-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	75916-4019-4	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	75916-4019-1	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	75916-4019-4	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	75916-4019-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	75916-4019-4	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	75916-4019-1	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	75916-4019-4	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	75916-4019-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	75916-4019-4	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	75916-4019-1	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	75916-4019-4	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	75916-4019-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	75916-4019-4	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	75916-4019-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	75916-4019-4	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	75916-4019-1	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	75916-4019-4	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	75916-4019-1	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	75916-4019-4	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	75916-4019-1	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	75916-4019-4	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	75916-4019-1	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	75916-4019-4	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	75916-4019-1	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	75916-4019-4	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	75916-4019-1	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	75916-4019-4	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	75916-4019-1	`e2bbac7714bc…`	`27bdfed8d636…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
75916-4019-1	2019-10-29	C162847	48780-1	960f7f55-cf8f-8e05-e053-dbdaa90a074a	Surfers Skin Sunscreen
75916-4019-4	2019-10-29	C162847	48780-1	960f7f55-cf8f-8e05-e053-dbdaa90a074a	Surfers Skin Sunscreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
75916-4019-1	Surfers Skin Sunscreen	1 in 1 BOX	CREAM	1	2
75916-4019-1	Surfers Skin Sunscreen	40 mL in 1 TUBE	CREAM	40	2
75916-4019-4	Surfers Skin Sunscreen	125 mL in 1 TUBE	CREAM	125	2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	SURFERS SKIN SUNSCREEN (OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SKIN ALIVE, LTD.]	2
OXYBENZONE	ACTIVE INGREDIENT	95OOS7VE0Y	SURFERS SKIN SUNSCREEN (OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SKIN ALIVE, LTD.]	2
TITANIUM DIOXIDE	ACTIVE INGREDIENT	15FIX9V2JP	SURFERS SKIN SUNSCREEN (OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SKIN ALIVE, LTD.]	2
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	SURFERS SKIN SUNSCREEN (OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SKIN ALIVE, LTD.]	2
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	SURFERS SKIN SUNSCREEN (OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SKIN ALIVE, LTD.]	2
OXYBENZONE	ACTIVE MOIETY	95OOS7VE0Y	SURFERS SKIN SUNSCREEN (OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SKIN ALIVE, LTD.]	2
TITANIUM DIOXIDE	ACTIVE MOIETY	15FIX9V2JP	SURFERS SKIN SUNSCREEN (OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SKIN ALIVE, LTD.]	2
ZINC OXIDE	ACTIVE MOIETY	SOI2LOH54Z	SURFERS SKIN SUNSCREEN (OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SKIN ALIVE, LTD.]	2
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	SURFERS SKIN SUNSCREEN (OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SKIN ALIVE, LTD.]	2
ALPHA-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	SURFERS SKIN SUNSCREEN (OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SKIN ALIVE, LTD.]	2
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	SURFERS SKIN SUNSCREEN (OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SKIN ALIVE, LTD.]	2
CYCLOMETHICONE	INACTIVE INGREDIENT	NMQ347994Z	SURFERS SKIN SUNSCREEN (OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SKIN ALIVE, LTD.]	2
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	SURFERS SKIN SUNSCREEN (OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SKIN ALIVE, LTD.]	2
HONEY	INACTIVE INGREDIENT	Y9H1V576FH	SURFERS SKIN SUNSCREEN (OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SKIN ALIVE, LTD.]	2
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	SURFERS SKIN SUNSCREEN (OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SKIN ALIVE, LTD.]	2
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	SURFERS SKIN SUNSCREEN (OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SKIN ALIVE, LTD.]	2
POLYSORBATE 60	INACTIVE INGREDIENT	CAL22UVI4M	SURFERS SKIN SUNSCREEN (OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SKIN ALIVE, LTD.]	2
SORBITAN MONOSTEARATE	INACTIVE INGREDIENT	NVZ4I0H58X	SURFERS SKIN SUNSCREEN (OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SKIN ALIVE, LTD.]	2
VITAMIN A PALMITATE	INACTIVE INGREDIENT	1D1K0N0VVC	SURFERS SKIN SUNSCREEN (OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SKIN ALIVE, LTD.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	SURFERS SKIN SUNSCREEN (OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SKIN ALIVE, LTD.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
75916-4019	SURFERS SKIN SUNSCREEN (OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SKIN ALIVE, LTD.]	2	Legacy NDC, 3 package rows	20110201_bd17a43b-231b-43b7-b65a-7b71389cb7c3.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
95OOS7VE0Y	OXYBENZONE	131-57-7	OXYBENZONE
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	Status
75916-4019-1	75916401901	1 in 1 BOX		Historical
75916-4019-4	75916401904	125 mL in 1 TUBE	125 ml	Historical