ATTITUDE

Product NDC: 61649-001
11-digit product format: 616490001
Labeler code: 61649
Product ID: 61649-001_186db25e-1c3d-4157-ac84-135cd0243aa2
Type: HUMAN OTC DRUG
Nonproprietary name: ZINC OXIDE
Dosage form: CREAM
Route: TOPICAL
Labeler: Bio Spectra
Application: part352
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2014-03-01
Marketing end: 0000-00-00
Substance: ZINC OXIDE
Active strength: 20 g/100g
NDC exclude flag: No
Listing certified through: 2020-12-31
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	61649-001		I	Inactivated by FDA	2026-08-11
excluded package	package	61649-001	61649-001-15	I	Inactivated by FDA	2026-08-11
excluded package	package	61649-001	61649-001-75	I	Inactivated by FDA	2026-08-11

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 1 · 57 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	61649-001-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61649-001-75	`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	61649-001-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61649-001-75	`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	61649-001-15	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61649-001-75	`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	61649-001-15	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61649-001-75	`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	61649-001-15	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61649-001-75	`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	61649-001-15	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61649-001-75	`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	61649-001-15	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61649-001-75	`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	61649-001-15	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61649-001-75	`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	61649-001-15	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61649-001-75	`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	61649-001-15	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61649-001-75	`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	61649-001-15	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61649-001-75	`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	61649-001-15	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61649-001-75	`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	61649-001-15	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	61649-001-75	`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	61649-001-15	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	61649-001-75	`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	61649-001-15	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	61649-001-75	`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	61649-001-75	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	61649-001-15	`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	61649-001-75	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	61649-001-15	`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	61649-001-75	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	61649-001-15	`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	61649-001-75	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	61649-001-15	`8dfbde2a14a4…`	`c9ff85d89658…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61649-001-15	2021-01-29	C162847	48780-1	ba0f9c33-2d66-a910-e053-dadaa90a0b85	ATTITUDE ®
61649-001-75	2021-01-29	C162847	48780-1	ba0f9c33-2d66-a910-e053-dadaa90a0b85	ATTITUDE ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
61649-001-15	ATTITUDE Mineral sunscreen Little ones - fragrance free	150 g in 1 TUBE	CREAM	150	6
61649-001-15	ATTITUDE Mineral sunscreen Little ones - fragrance free	1 in 1 CARTON	CREAM	1	6
61649-001-75	ATTITUDE Mineral sunscreen Little ones - fragrance free	75 g in 1 TUBE	CREAM	75	6
61649-001-75	ATTITUDE Mineral sunscreen Little ones - fragrance free	1 in 1 CARTON	CREAM	1	6

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	ATTITUDE MINERAL SUNSCREEN (ZINC OXIDE) CREAM [BIO SPECTRA]	2
ZINC OXIDE	ACTIVE MOIETY	SOI2LOH54Z	ATTITUDE MINERAL SUNSCREEN (ZINC OXIDE) CREAM [BIO SPECTRA]	2
CAPRYLYL GLYCOL	INACTIVE INGREDIENT	00YIU5438U	ATTITUDE MINERAL SUNSCREEN (ZINC OXIDE) CREAM [BIO SPECTRA]	2
CETEARYL GLUCOSIDE	INACTIVE INGREDIENT	09FUA47KNA	ATTITUDE MINERAL SUNSCREEN (ZINC OXIDE) CREAM [BIO SPECTRA]	2
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	ATTITUDE MINERAL SUNSCREEN (ZINC OXIDE) CREAM [BIO SPECTRA]	2
ETHYLHEXYLGLYCERIN	INACTIVE INGREDIENT	147D247K3P	ATTITUDE MINERAL SUNSCREEN (ZINC OXIDE) CREAM [BIO SPECTRA]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	ATTITUDE MINERAL SUNSCREEN (ZINC OXIDE) CREAM [BIO SPECTRA]	2
GLYCERYL ISOSTEARATE	INACTIVE INGREDIENT	HYE7O27HAO	ATTITUDE MINERAL SUNSCREEN (ZINC OXIDE) CREAM [BIO SPECTRA]	2
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	ATTITUDE MINERAL SUNSCREEN (ZINC OXIDE) CREAM [BIO SPECTRA]	2
NIACINAMIDE	INACTIVE INGREDIENT	25X51I8RD4	ATTITUDE MINERAL SUNSCREEN (ZINC OXIDE) CREAM [BIO SPECTRA]	2
POLYHYDROXYSTEARIC ACID (2300 MW)	INACTIVE INGREDIENT	YXH47AOU0F	ATTITUDE MINERAL SUNSCREEN (ZINC OXIDE) CREAM [BIO SPECTRA]	2
SODIUM STEAROYL GLUTAMATE	INACTIVE INGREDIENT	65A9F4P024	ATTITUDE MINERAL SUNSCREEN (ZINC OXIDE) CREAM [BIO SPECTRA]	2
TETRASODIUM IMINODISUCCINATE	INACTIVE INGREDIENT	GYS41J2635	ATTITUDE MINERAL SUNSCREEN (ZINC OXIDE) CREAM [BIO SPECTRA]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	ATTITUDE MINERAL SUNSCREEN (ZINC OXIDE) CREAM [BIO SPECTRA]	2
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	ATTITUDE MINERAL SUNSCREEN (ZINC OXIDE) CREAM [BIO SPECTRA]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61649-001	ATTITUDE MINERAL SUNSCREEN LITTLE ONES - FRAGRANCE FREE (ZINC OXIDE) CREAM [BIO SPECTRA]	6	Legacy NDC, 4 package rows	20180912_bfd4e49b-b279-4646-b457-c6d359ad10aa.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
61649-001-15	61649000115	150 g in 1 TUBE	150 g	Historical
61649-001-75	61649000175	75 g in 1 TUBE	75 g	Historical