Alba Mineral Sunscreen Sport SPF45 Broad Spectrum

Product NDC: 61995-2400
11-digit product format: 619952400
Labeler code: 61995
Product ID: 61995-2400_05680826-a5ef-6685-e054-00144ff88e88
Type: HUMAN OTC DRUG
Nonproprietary name: Zinc Oxide, Titanium Dioxide
Dosage form: CREAM
Route: TOPICAL
Labeler: The Hain Celestial Group, Inc.
Application: part352
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2013-12-27
Marketing end: 0000-00-00
Substance: TITANIUM DIOXIDE; ZINC OXIDE
Active strength: 7 g/100g; g/100g
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	61995-2400		I	Inactivated by FDA		2026-10-15
excluded package	package	61995-2400	61995-2400-4	I	Inactivated by FDA		2026-10-15

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61995-2400-4	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61995-2400-4	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61995-2400-4	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61995-2400-4	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61995-2400-4	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61995-2400-4	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61995-2400-4	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61995-2400-4	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61995-2400-4	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61995-2400-4	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61995-2400-4	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61995-2400-4	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	61995-2400-4	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	61995-2400-4	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	61995-2400-4	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	61995-2400-4	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	61995-2400-4	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	61995-2400-4	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	61995-2400-4	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	61995-2400-4	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	61995-2400-4	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	61995-2400-4	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7792dadb-52b6-46b6-8fdf-80b1171065b5	Product name	1	20180810
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61995-2400-4	2020-01-31	C162847	48780-1	9d75b9d0-0d8d-f424-e053-dadaa90a57ce	05680826-a5ee-6685-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61995-2400-4	Alba Mineral Sunscreen Sport SPF45 Broad Spectrum	113 g in 1 TUBE	CREAM	113		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TITANIUM DIOXIDE	ACTIVE INGREDIENT	15FIX9V2JP	ALBA MINERAL SUNSCREEN SPORT SPF45 BROAD SPECTRUM (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [THE HAIN CELESTIAL GROUP, INC.]	1
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	ALBA MINERAL SUNSCREEN SPORT SPF45 BROAD SPECTRUM (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [THE HAIN CELESTIAL GROUP, INC.]	1
TITANIUM DIOXIDE	ACTIVE MOIETY	15FIX9V2JP	ALBA MINERAL SUNSCREEN SPORT SPF45 BROAD SPECTRUM (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [THE HAIN CELESTIAL GROUP, INC.]	1
ZINC OXIDE	ACTIVE MOIETY	SOI2LOH54Z	ALBA MINERAL SUNSCREEN SPORT SPF45 BROAD SPECTRUM (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [THE HAIN CELESTIAL GROUP, INC.]	1
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	ALBA MINERAL SUNSCREEN SPORT SPF45 BROAD SPECTRUM (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [THE HAIN CELESTIAL GROUP, INC.]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	ALBA MINERAL SUNSCREEN SPORT SPF45 BROAD SPECTRUM (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [THE HAIN CELESTIAL GROUP, INC.]	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	ALBA MINERAL SUNSCREEN SPORT SPF45 BROAD SPECTRUM (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [THE HAIN CELESTIAL GROUP, INC.]	1
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	ALBA MINERAL SUNSCREEN SPORT SPF45 BROAD SPECTRUM (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [THE HAIN CELESTIAL GROUP, INC.]	1
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	ALBA MINERAL SUNSCREEN SPORT SPF45 BROAD SPECTRUM (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [THE HAIN CELESTIAL GROUP, INC.]	1
BRASSICA RAPA SUBSP. OLEIFERA OIL	INACTIVE INGREDIENT	N4G8379626	ALBA MINERAL SUNSCREEN SPORT SPF45 BROAD SPECTRUM (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [THE HAIN CELESTIAL GROUP, INC.]	1
COCO-CAPRYLATE/CAPRATE	INACTIVE INGREDIENT	8D9H4QU99H	ALBA MINERAL SUNSCREEN SPORT SPF45 BROAD SPECTRUM (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [THE HAIN CELESTIAL GROUP, INC.]	1
COCONUT ALKANES	INACTIVE INGREDIENT	1E5KJY107T	ALBA MINERAL SUNSCREEN SPORT SPF45 BROAD SPECTRUM (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [THE HAIN CELESTIAL GROUP, INC.]	1
CRAMBE HISPANICA SUBSP. ABYSSINICA SEED OIL	INACTIVE INGREDIENT	0QW9S92J3K	ALBA MINERAL SUNSCREEN SPORT SPF45 BROAD SPECTRUM (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [THE HAIN CELESTIAL GROUP, INC.]	1
ECHINACEA PURPUREA ROOT	INACTIVE INGREDIENT	OS64WTR4KU	ALBA MINERAL SUNSCREEN SPORT SPF45 BROAD SPECTRUM (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [THE HAIN CELESTIAL GROUP, INC.]	1
GINKGO	INACTIVE INGREDIENT	19FUJ2C58T	ALBA MINERAL SUNSCREEN SPORT SPF45 BROAD SPECTRUM (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [THE HAIN CELESTIAL GROUP, INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	ALBA MINERAL SUNSCREEN SPORT SPF45 BROAD SPECTRUM (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [THE HAIN CELESTIAL GROUP, INC.]	1
GREEN TEA LEAF	INACTIVE INGREDIENT	W2ZU1RY8B0	ALBA MINERAL SUNSCREEN SPORT SPF45 BROAD SPECTRUM (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [THE HAIN CELESTIAL GROUP, INC.]	1
ISOAMYL LAURATE	INACTIVE INGREDIENT	M1SLX00M3M	ALBA MINERAL SUNSCREEN SPORT SPF45 BROAD SPECTRUM (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [THE HAIN CELESTIAL GROUP, INC.]	1
MAGNESIUM SULFATE	INACTIVE INGREDIENT	DE08037SAB	ALBA MINERAL SUNSCREEN SPORT SPF45 BROAD SPECTRUM (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [THE HAIN CELESTIAL GROUP, INC.]	1
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	ALBA MINERAL SUNSCREEN SPORT SPF45 BROAD SPECTRUM (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [THE HAIN CELESTIAL GROUP, INC.]	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	ALBA MINERAL SUNSCREEN SPORT SPF45 BROAD SPECTRUM (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [THE HAIN CELESTIAL GROUP, INC.]	1
POLYGLYCERYL-3 RICINOLEATE	INACTIVE INGREDIENT	MZQ63P0N0W	ALBA MINERAL SUNSCREEN SPORT SPF45 BROAD SPECTRUM (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [THE HAIN CELESTIAL GROUP, INC.]	1
POLYGONUM AVICULARE TOP	INACTIVE INGREDIENT	ZCD6009IUF	ALBA MINERAL SUNSCREEN SPORT SPF45 BROAD SPECTRUM (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [THE HAIN CELESTIAL GROUP, INC.]	1
POLYHYDROXYSTEARIC ACID (2300 MW)	INACTIVE INGREDIENT	YXH47AOU0F	ALBA MINERAL SUNSCREEN SPORT SPF45 BROAD SPECTRUM (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [THE HAIN CELESTIAL GROUP, INC.]	1
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	ALBA MINERAL SUNSCREEN SPORT SPF45 BROAD SPECTRUM (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [THE HAIN CELESTIAL GROUP, INC.]	1
SHEA BUTTER	INACTIVE INGREDIENT	K49155WL9Y	ALBA MINERAL SUNSCREEN SPORT SPF45 BROAD SPECTRUM (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [THE HAIN CELESTIAL GROUP, INC.]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	ALBA MINERAL SUNSCREEN SPORT SPF45 BROAD SPECTRUM (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [THE HAIN CELESTIAL GROUP, INC.]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	ALBA MINERAL SUNSCREEN SPORT SPF45 BROAD SPECTRUM (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [THE HAIN CELESTIAL GROUP, INC.]	1
SORBITAN SESQUIOLEATE	INACTIVE INGREDIENT	0W8RRI5W5A	ALBA MINERAL SUNSCREEN SPORT SPF45 BROAD SPECTRUM (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [THE HAIN CELESTIAL GROUP, INC.]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	ALBA MINERAL SUNSCREEN SPORT SPF45 BROAD SPECTRUM (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [THE HAIN CELESTIAL GROUP, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	ALBA MINERAL SUNSCREEN SPORT SPF45 BROAD SPECTRUM (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [THE HAIN CELESTIAL GROUP, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61995-2400	ALBA MINERAL SUNSCREEN SPORT SPF45 BROAD SPECTRUM (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [THE HAIN CELESTIAL GROUP, INC.]	1	Legacy NDC, 1 package rows	20141015_05680826-a5ee-6685-e054-00144ff88e88.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
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
61995-2400-4	61995240004	113 g in 1 TUBE	113 g	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Zinc Oxide, Titanium Dioxide - The Hain Celestial Group, Inc.	The Hain Celestial Group, Inc.	2014-10-14	HUMAN OTC DRUG LABEL	1