Sunscreen Broad Spectrum SPF 50

Product NDC: 69718-155
11-digit product format: 697180155
Labeler code: 69718
Product ID: 69718-155_b9a1d098-9d70-40fd-a3ec-cac0522330db
Type: HUMAN OTC DRUG
Nonproprietary name: Zinc Oxide, Octinoxate
Dosage form: CREAM
Route: TOPICAL
Labeler: Vitality Institute Medical Products
Application: part352
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2015-03-26
Marketing end: 0000-00-00
Substance: ZINC OXIDE; OCTINOXATE
Active strength: 10 g/17.5mL; g/17.5mL
NDC exclude flag: E
Listing certified through: 2018-12-31
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	69718-155		I	Inactivated by FDA	2026-10-16
excluded package	package	69718-155	69718-155-02	I	Inactivated by FDA	2026-10-16
excluded package	package	69718-155	69718-155-04	I	Inactivated by FDA	2026-10-16

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	69718-155-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69718-155-04	`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	69718-155-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69718-155-04	`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	69718-155-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69718-155-04	`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	69718-155-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69718-155-04	`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	69718-155-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69718-155-04	`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	69718-155-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69718-155-04	`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	69718-155-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69718-155-04	`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	69718-155-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69718-155-04	`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	69718-155-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69718-155-04	`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	69718-155-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69718-155-04	`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	69718-155-02	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69718-155-04	`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	69718-155-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69718-155-04	`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	69718-155-02	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	69718-155-04	`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	69718-155-02	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	69718-155-04	`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	69718-155-02	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	69718-155-04	`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	69718-155-02	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	69718-155-04	`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	69718-155-02	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	69718-155-04	`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	69718-155-02	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	69718-155-04	`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	69718-155-02	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	69718-155-04	`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	69718-155-02	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	69718-155-04	`e2bbac7714bc…`	`27bdfed8d636…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f47a510b-6679-4664-b2d6-47b5c4afe7cc	Product name	4	20260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61c	Product name	2	20250515
0306390c-dd77-4363-afe0-63c58088b2a1	Product name	1	20220120
503ea967-4b9c-48cf-9e87-c7975295849d	Product name	2	20220120
190f2a5b-bbc8-65c7-fcb0-97891307b917	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69718-155-02	2020-01-31	C162847	48780-1	9d75b9d0-c961-f424-e053-dadaa90a57ce	Vitality Institute Skin Care System SPF 50+
69718-155-04	2020-01-31	C162847	48780-1	9d75b9d0-c961-f424-e053-dadaa90a57ce	Vitality Institute Skin Care System SPF 50+

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
69718-155-01	Sunscreen Broad Spectrum SPF 50Vitality Institute	30 mL in 1 TUBE	CREAM	30	7
69718-155-02	Sunscreen Broad Spectrum SPF 50Vitality Institute	1 in 1 BOX	CREAM	1	7
69718-155-03	Sunscreen Broad Spectrum SPF 50Vitality Institute	59 mL in 1 TUBE	CREAM	59	7
69718-155-04	Sunscreen Broad Spectrum SPF 50Vitality Institute	1 in 1 BOX	CREAM	1	7

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	SUNSCREEN BROAD SPECTRUM SPF 50 VITALITY INSTITUTE (ZINC OXIDE, OCTINOXATE) CREAM [VITALITY INSTITUTE MEDICAL PRODUCTS]	7
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	SUNSCREEN BROAD SPECTRUM SPF 50 VITALITY INSTITUTE (ZINC OXIDE, OCTINOXATE) CREAM [VITALITY INSTITUTE MEDICAL PRODUCTS]	7
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	SUNSCREEN BROAD SPECTRUM SPF 50 VITALITY INSTITUTE (ZINC OXIDE, OCTINOXATE) CREAM [VITALITY INSTITUTE MEDICAL PRODUCTS]	7
ZINC CATION	ACTIVE MOIETY	13S1S8SF37	SUNSCREEN BROAD SPECTRUM SPF 50 VITALITY INSTITUTE (ZINC OXIDE, OCTINOXATE) CREAM [VITALITY INSTITUTE MEDICAL PRODUCTS]	7
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	SUNSCREEN BROAD SPECTRUM SPF 50 VITALITY INSTITUTE (ZINC OXIDE, OCTINOXATE) CREAM [VITALITY INSTITUTE MEDICAL PRODUCTS]	7
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	SUNSCREEN BROAD SPECTRUM SPF 50 VITALITY INSTITUTE (ZINC OXIDE, OCTINOXATE) CREAM [VITALITY INSTITUTE MEDICAL PRODUCTS]	7
C12-15 ALKYL BENZOATE	INACTIVE INGREDIENT	A9EJ3J61HQ	SUNSCREEN BROAD SPECTRUM SPF 50 VITALITY INSTITUTE (ZINC OXIDE, OCTINOXATE) CREAM [VITALITY INSTITUTE MEDICAL PRODUCTS]	7
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)	INACTIVE INGREDIENT	71DD5V995L	SUNSCREEN BROAD SPECTRUM SPF 50 VITALITY INSTITUTE (ZINC OXIDE, OCTINOXATE) CREAM [VITALITY INSTITUTE MEDICAL PRODUCTS]	7
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	SUNSCREEN BROAD SPECTRUM SPF 50 VITALITY INSTITUTE (ZINC OXIDE, OCTINOXATE) CREAM [VITALITY INSTITUTE MEDICAL PRODUCTS]	7
CHAMAEMELUM NOBILE FLOWER	INACTIVE INGREDIENT	O2T154T6OG	SUNSCREEN BROAD SPECTRUM SPF 50 VITALITY INSTITUTE (ZINC OXIDE, OCTINOXATE) CREAM [VITALITY INSTITUTE MEDICAL PRODUCTS]	7
COCO-CAPRYLATE/CAPRATE	INACTIVE INGREDIENT	8D9H4QU99H	SUNSCREEN BROAD SPECTRUM SPF 50 VITALITY INSTITUTE (ZINC OXIDE, OCTINOXATE) CREAM [VITALITY INSTITUTE MEDICAL PRODUCTS]	7
COCONUT ALKANES	INACTIVE INGREDIENT	1E5KJY107T	SUNSCREEN BROAD SPECTRUM SPF 50 VITALITY INSTITUTE (ZINC OXIDE, OCTINOXATE) CREAM [VITALITY INSTITUTE MEDICAL PRODUCTS]	7
CYCLOMETHICONE 5	INACTIVE INGREDIENT	0THT5PCI0R	SUNSCREEN BROAD SPECTRUM SPF 50 VITALITY INSTITUTE (ZINC OXIDE, OCTINOXATE) CREAM [VITALITY INSTITUTE MEDICAL PRODUCTS]	7
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	SUNSCREEN BROAD SPECTRUM SPF 50 VITALITY INSTITUTE (ZINC OXIDE, OCTINOXATE) CREAM [VITALITY INSTITUTE MEDICAL PRODUCTS]	7
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	SUNSCREEN BROAD SPECTRUM SPF 50 VITALITY INSTITUTE (ZINC OXIDE, OCTINOXATE) CREAM [VITALITY INSTITUTE MEDICAL PRODUCTS]	7
ETHYLHEXYLGLYCERIN	INACTIVE INGREDIENT	147D247K3P	SUNSCREEN BROAD SPECTRUM SPF 50 VITALITY INSTITUTE (ZINC OXIDE, OCTINOXATE) CREAM [VITALITY INSTITUTE MEDICAL PRODUCTS]	7
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	SUNSCREEN BROAD SPECTRUM SPF 50 VITALITY INSTITUTE (ZINC OXIDE, OCTINOXATE) CREAM [VITALITY INSTITUTE MEDICAL PRODUCTS]	7
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	SUNSCREEN BROAD SPECTRUM SPF 50 VITALITY INSTITUTE (ZINC OXIDE, OCTINOXATE) CREAM [VITALITY INSTITUTE MEDICAL PRODUCTS]	7
GREEN TEA LEAF	INACTIVE INGREDIENT	W2ZU1RY8B0	SUNSCREEN BROAD SPECTRUM SPF 50 VITALITY INSTITUTE (ZINC OXIDE, OCTINOXATE) CREAM [VITALITY INSTITUTE MEDICAL PRODUCTS]	7
OCTYLDODECYL NEOPENTANOATE	INACTIVE INGREDIENT	X8725R883T	SUNSCREEN BROAD SPECTRUM SPF 50 VITALITY INSTITUTE (ZINC OXIDE, OCTINOXATE) CREAM [VITALITY INSTITUTE MEDICAL PRODUCTS]	7
PEG-100 STEARATE	INACTIVE INGREDIENT	YD01N1999R	SUNSCREEN BROAD SPECTRUM SPF 50 VITALITY INSTITUTE (ZINC OXIDE, OCTINOXATE) CREAM [VITALITY INSTITUTE MEDICAL PRODUCTS]	7
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	SUNSCREEN BROAD SPECTRUM SPF 50 VITALITY INSTITUTE (ZINC OXIDE, OCTINOXATE) CREAM [VITALITY INSTITUTE MEDICAL PRODUCTS]	7
POLYHYDROXYSTEARIC ACID (2300 MW)	INACTIVE INGREDIENT	YXH47AOU0F	SUNSCREEN BROAD SPECTRUM SPF 50 VITALITY INSTITUTE (ZINC OXIDE, OCTINOXATE) CREAM [VITALITY INSTITUTE MEDICAL PRODUCTS]	7
POLYSORBATE 60	INACTIVE INGREDIENT	CAL22UVI4M	SUNSCREEN BROAD SPECTRUM SPF 50 VITALITY INSTITUTE (ZINC OXIDE, OCTINOXATE) CREAM [VITALITY INSTITUTE MEDICAL PRODUCTS]	7
PUERARIA MONTANA VAR. LOBATA ROOT	INACTIVE INGREDIENT	PET93F4I3C	SUNSCREEN BROAD SPECTRUM SPF 50 VITALITY INSTITUTE (ZINC OXIDE, OCTINOXATE) CREAM [VITALITY INSTITUTE MEDICAL PRODUCTS]	7
PUMMELO	INACTIVE INGREDIENT	ET1TN5W71X	SUNSCREEN BROAD SPECTRUM SPF 50 VITALITY INSTITUTE (ZINC OXIDE, OCTINOXATE) CREAM [VITALITY INSTITUTE MEDICAL PRODUCTS]	7
WATER	INACTIVE INGREDIENT	059QF0KO0R	SUNSCREEN BROAD SPECTRUM SPF 50 VITALITY INSTITUTE (ZINC OXIDE, OCTINOXATE) CREAM [VITALITY INSTITUTE MEDICAL PRODUCTS]	7
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	SUNSCREEN BROAD SPECTRUM SPF 50 VITALITY INSTITUTE (ZINC OXIDE, OCTINOXATE) CREAM [VITALITY INSTITUTE MEDICAL PRODUCTS]	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69718-155	SUNSCREEN BROAD SPECTRUM SPF 50 VITALITY INSTITUTE (ZINC OXIDE, OCTINOXATE) CREAM [VITALITY INSTITUTE MEDICAL PRODUCTS]	7	Legacy NDC, 4 package rows	20150410_507c46c3-3fd8-491e-850c-3060c7f488cd.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
69718-155-01	69718015501	30 mL in 1 TUBE	30 ml	Historical
69718-155-02	69718015502	1 in 1 BOX		Historical
69718-155-03	69718015503	59 mL in 1 TUBE	59 ml	Historical
69718-155-04	69718015504	1 in 1 BOX		Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Vitality Institute Skin Care System SPF 50+	Vitality Institute Medical Products \| VEGE-KURL, INC	2015-04-10	HUMAN OTC DRUG LABEL	7