Botanics Hydrating Day All Bright Sunscreen Broad Spectrum SPF 15

Product NDC: 11489-080
11-digit product format: 114890080
Labeler code: 11489
Product ID: 11489-080_d9325225-4f19-4cf5-92d3-f4cddcb7127c
Type: HUMAN OTC DRUG
Nonproprietary name: Avobenzone, Octisalate, Octocrylene
Dosage form: CREAM
Route: TOPICAL
Labeler: BCM Ltd
Application: part352
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2013-01-14
Marketing end: 0000-00-00
Substance: AVOBENZONE; OCTISALATE; OCTOCRYLENE
Active strength: 2 g/50g; g/50g; g/50g
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	11489-080		I	Inactivated by FDA		2026-10-16
excluded package	package	11489-080	11489-080-01	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 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	11489-080-01	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	11489-080-01	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	11489-080-01	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	11489-080-01	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	11489-080-01	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	11489-080-01	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	11489-080-01	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	11489-080-01	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	11489-080-01	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	11489-080-01	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	11489-080-01	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	11489-080-01	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	11489-080-01	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	11489-080-01	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	11489-080-01	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	11489-080-01	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	11489-080-01	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	11489-080-01	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	11489-080-01	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	11489-080-01	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	11489-080-01	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	11489-080-01	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
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
11489-080-01	2020-01-31	C162847	48780-1	9d75b9d0-eba8-f424-e053-dadaa90a57ce	ddaa5c2d-fefa-4da3-987c-a363e85a440d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
11489-080-01	Botanics Hydrating Day All Bright Sunscreen Broad Spectrum SPF 15	50 g in 1 JAR	CREAM	50		2
11489-080-01	Botanics Hydrating Day All Bright Sunscreen Broad Spectrum SPF 15	1 in 1 CARTON	CREAM	1		2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AVOBENZONE	ACTIVE INGREDIENT	G63QQF2NOX	BOTANICS HYDRATING DAY ALL BRIGHT SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]	2
OCTISALATE	ACTIVE INGREDIENT	4X49Y0596W	BOTANICS HYDRATING DAY ALL BRIGHT SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]	2
OCTOCRYLENE	ACTIVE INGREDIENT	5A68WGF6WM	BOTANICS HYDRATING DAY ALL BRIGHT SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]	2
AVOBENZONE	ACTIVE MOIETY	G63QQF2NOX	BOTANICS HYDRATING DAY ALL BRIGHT SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]	2
OCTISALATE	ACTIVE MOIETY	4X49Y0596W	BOTANICS HYDRATING DAY ALL BRIGHT SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]	2
OCTOCRYLENE	ACTIVE MOIETY	5A68WGF6WM	BOTANICS HYDRATING DAY ALL BRIGHT SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]	2
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	BOTANICS HYDRATING DAY ALL BRIGHT SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]	2
ALMOND OIL	INACTIVE INGREDIENT	66YXD4DKO9	BOTANICS HYDRATING DAY ALL BRIGHT SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]	2
BENZOIC ACID	INACTIVE INGREDIENT	8SKN0B0MIM	BOTANICS HYDRATING DAY ALL BRIGHT SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]	2
C12-15 ALKYL BENZOATE	INACTIVE INGREDIENT	A9EJ3J61HQ	BOTANICS HYDRATING DAY ALL BRIGHT SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]	2
CAPRYLYL GLYCOL	INACTIVE INGREDIENT	00YIU5438U	BOTANICS HYDRATING DAY ALL BRIGHT SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]	2
CETEARYL OLIVATE	INACTIVE INGREDIENT	58B69Q84JO	BOTANICS HYDRATING DAY ALL BRIGHT SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]	2
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	BOTANICS HYDRATING DAY ALL BRIGHT SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]	2
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	BOTANICS HYDRATING DAY ALL BRIGHT SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]	2
DEHYDROACETIC ACID	INACTIVE INGREDIENT	2KAG279R6R	BOTANICS HYDRATING DAY ALL BRIGHT SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]	2
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	BOTANICS HYDRATING DAY ALL BRIGHT SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]	2
DIPROPYLENE GLYCOL	INACTIVE INGREDIENT	E107L85C40	BOTANICS HYDRATING DAY ALL BRIGHT SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]	2
EDETATE SODIUM	INACTIVE INGREDIENT	MP1J8420LU	BOTANICS HYDRATING DAY ALL BRIGHT SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]	2
ETHYLHEXYLGLYCERIN	INACTIVE INGREDIENT	147D247K3P	BOTANICS HYDRATING DAY ALL BRIGHT SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	BOTANICS HYDRATING DAY ALL BRIGHT SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]	2
HIBISCUS SABDARIFFA FLOWER	INACTIVE INGREDIENT	45TGG6IU6M	BOTANICS HYDRATING DAY ALL BRIGHT SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]	2
HYALURONATE SODIUM	INACTIVE INGREDIENT	YSE9PPT4TH	BOTANICS HYDRATING DAY ALL BRIGHT SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]	2
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	BOTANICS HYDRATING DAY ALL BRIGHT SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]	2
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	BOTANICS HYDRATING DAY ALL BRIGHT SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]	2
SHEA BUTTER	INACTIVE INGREDIENT	K49155WL9Y	BOTANICS HYDRATING DAY ALL BRIGHT SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]	2
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	BOTANICS HYDRATING DAY ALL BRIGHT SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]	2
SODIUM POLYACRYLATE (8000 MW)	INACTIVE INGREDIENT	285CYO341L	BOTANICS HYDRATING DAY ALL BRIGHT SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]	2
SORBITAN OLIVATE	INACTIVE INGREDIENT	MDL271E3GR	BOTANICS HYDRATING DAY ALL BRIGHT SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]	2
TRIBEHENIN	INACTIVE INGREDIENT	8OC9U7TQZ0	BOTANICS HYDRATING DAY ALL BRIGHT SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	BOTANICS HYDRATING DAY ALL BRIGHT SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]	2
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	BOTANICS HYDRATING DAY ALL BRIGHT SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11489-080	BOTANICS HYDRATING DAY ALL BRIGHT SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]	2	Legacy NDC, 2 package rows	20130114_ddaa5c2d-fefa-4da3-987c-a363e85a440d.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
G63QQF2NOX	AVOBENZONE	70356-09-1	AVOBENZONE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE
5A68WGF6WM	OCTOCRYLENE	6197-30-4	OCTOCRYLENE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
11489-080-01	11489008001	50 g in 1 JAR	50 g	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Avobenzone, Octisalate, Octocrylene - BCM Ltd \| The Boots Company Plc	BCM Ltd \| The Boots Company Plc	2012-12-20	HUMAN OTC DRUG LABEL	2