BOTANICAL SOOTHING

Product NDC: 70764-201
11-digit product format: 707640201
Labeler code: 70764
Product ID: 70764-201_474bb04f-2be5-2dd9-e063-6394a90a6a3c
Type: HUMAN OTC DRUG
Nonproprietary name: OCTINOXATE, OCTISALATE, ZINC OXIDE
Dosage form: CREAM
Route: TOPICAL
Labeler: CONTROL CORRECTIVE SKINCARE INC
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2016-06-08
Substance: OCTINOXATE; OCTISALATE; ZINC OXIDE
Active strength: 6.9; 3; 4 g/100mL; g/100mL; g/100mL
Pharmacologic classes: Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 18 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	70764-201-52	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	70764-201-52	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	70764-201-52	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	70764-201-52	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	70764-201-52	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	70764-201-52	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70764-201-52	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70764-201-52	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70764-201-52	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: BOTANICAL SOOTHING
Brand name suffix: SPF-30
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OCTINOXATE	6.9 g/100mL
OCTISALATE	3 g/100mL
ZINC OXIDE	4 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4Y5P7MUD51	Internal UNII lookup
4X49Y0596W	Internal UNII lookup
SOI2LOH54Z	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
00a923fe-e6da-420e-a705-4773ecc2176b	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f47a510b-6679-4664-b2d6-47b5c4afe7cc	Product name	4	20260217
16a2c1cd-ae95-d910-f03d-7e06b11dd243	Product name	5	20260202
653485de-0601-41e4-82db-7a60bb223e27	Product name	1	20251024
030ce964-9b2d-45aa-b5d3-f78ce03ef61c	Product name	2	20250515
23fb3cda-2b50-f3d3-ebde-f542350bd77b	Product name	4	20240828
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
081b54f0-4545-48b6-b854-03e1401f09ea	Product name	1	20230112
0306390c-dd77-4363-afe0-63c58088b2a1	Product name	1	20220120
503ea967-4b9c-48cf-9e87-c7975295849d	Product name	2	20220120
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
aead65a2-216e-4ff8-a178-44aab77c24ed	Product name	1	20180531
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
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
70764-201-52	2025-12-31	C162847	48780-1	2cef2736-858d-d83d-e063-dadaa90ab31f	CONTROL CORRECTIVE - BOTANICAL SOOTHING (70764-201)
70764-201-52	2025-01-30	C162847	48780-1	2cef2736-858d-d83d-e063-dadaa90ab31f	CONTROL CORRECTIVE - BOTANICAL SOOTHING (70764-201)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70764-201-22	BOTANICAL SOOTHINGSPF-30	74 mL in 1 BOTTLE	CREAM	74		6
70764-201-52	BOTANICAL SOOTHINGSPF-30	1 in 1 BOX	CREAM	1		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70764-201	BOTANICAL SOOTHING SPF-30 (OCTINOXATE, OCTISALATE, ZINC OXIDE) CREAM [CONTROL CORRECTIVE SKINCARE INC]	5	Current NDC, Legacy NDC, 2 package rows	20230923_00a923fe-e6da-420e-a705-4773ecc2176b.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 62 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
e.l.f. Wake the E.L.F. Up Skincare Set	AVOBENZONE, OCTISALATE, OCTOCRYLENE, HOMOSALATE	e.l.f. Cosmetics, Inc	4b20c56a-3e91-3419-e063-6294a90ad361	2026-02-18	Warnings	Exact identifier application number: M020
Dermatone Mineral SPF 30	ZINC OXIDE 20%	Dermatone Labs LLC	26e3209f-cb5c-484e-9b2e-74dc397d4790	2026-02-18	Warnings	Exact identifier application number: M020
SHISEIDO ESSENTIAL ENERGY HYDRATING DAY	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	SHISEIDO AMERICAS CORPORATION	8b88039a-09fe-458b-b80f-49cde49b6595	2026-02-17	Warnings	Exact identifier application number: M020
cle de peau BEAUTE SYNACTIF DAYTIME MOISTURIZER ENRICHED n	AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE	SHISEIDO AMERICAS CORPORATION	f3729d0b-e601-48bb-9907-1d6e3ab31996	2026-02-17	Warnings	Exact identifier application number: M020
Luminesce Daily Moisturizing Complex	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Velovita Inc.	4b0c2213-8667-be6f-e063-6394a90a5e86	2026-02-17	Warnings	Exact identifier application number: M020
Sport Sunscreen SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE	Valu Merchandisers Company	e168f8e8-22d0-4a60-b9f9-dec9d0fab3f1	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M020
Sunscreen for Kids SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE	Valu Merchandisers Company	cfc3b202-6511-450a-b3c1-2d8e8ebc070d	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M020
Sport Sunscreen SPF 70	AVOBENZONE, HOMOSALATE, OCTISALATE	Valu Merchandisers Company	5a8af0ea-b31c-456a-bc23-31e2473ca75a	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M020
Sparms 100% Organic Face Sunscreen	ZINC OXIDE SUNSCREEN	VEGANIC SKN LIMITED	4ae6b187-142b-e4a6-e063-6294a90af365	2026-02-15	Warnings	Exact identifier application number: M020
Lotus Harmony - Quinn Shield Sunscreen SPF50	ZINC OXIDE SUNSCREEN	VEGANIC SKN LIMITED	4ae73d23-1118-716c-e063-6394a90a68c7	2026-02-15	Warnings	Exact identifier application number: M020
Avebonzone, Homosalate, Octisalate	AVEBONZONE, HOMOSALATE, OCTISALATE	Amazon.com Services LLC	4ab542aa-bd05-ba7a-e063-6294a90ae584	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M020
Beauty Hydrating	HOMOSALATE, ZINC OXIDE	Topco Associates LLC	6e88ccc8-8576-4573-8a5b-28e64008a349	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M020
Wotnot Naturals Natural Zinc Sunscreen SPF 30	ZINC OXIDE	ECOdirect Pty Ltd (Trading as Wotnot Naturals)	4ab759ae-0c1c-bddc-e063-6394a90a1d09	2026-02-13	Warnings	Exact identifier application number: M020
Wotnot Naturals Natural Zinc Sunscreen SPF 30	ZINC OXIDE	ECOdirect Pty Ltd (Trading as Wotnot Naturals)	4ab83b34-9376-d169-e063-6394a90a18cd	2026-02-13	Warnings	Exact identifier application number: M020
Homosalate, Octisalate, Zinc oxide	HOMOSALATE, OCTISALATE, ZINC OXIDE	Topco Associates LLC	48fb9a3c-c058-ce71-e063-6294a90aaf1e	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M020
Ambi Even and Clear Facial Moisturizer	HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 3%, AVOBENZONE 3%	73453-112	469440e9-bf47-bebd-e063-6294a90acca2	2026-02-12	Warnings	Exact identifier application number: M020
Intelligent Defense Mineral Sunscreen	ZINC OXIDE	GLO PHARMA	4ab664aa-5f0c-7ddb-e063-6294a90a9753	2026-02-12	Warnings	Exact identifier application number: M020
Sky and Sol Sports Sunscreen	ZINC OXIDE	Delta Ecommerce LLC	4dd054cd-8f53-4210-e063-6394a90ade27	2026-02-12	Warnings	Exact identifier application number: M020
Sky and Sol Kids and Babies Sunscreen	ZINC OXIDE	Delta Ecommerce LLC	4de67653-ab31-c6b2-e063-6394a90a7e8c	2026-02-12	Warnings	Exact identifier application number: M020
Eva Claire Natural Professional Sunscreen	AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE	Eva Claire Cosmetics Co., Ltd.	4a870452-cac2-4d2c-e063-6294a90abb07	2026-02-11	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70764-201-22	70764020122	74 mL in 1 BOTTLE	74 ml					Historical
70764-201-52	70764020152	1 BOTTLE in 1 BOX (70764-201-52) / 74 mL in 1 BOTTLE (70764-201-22)	1 bottle	2016-06-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CONTROL CORRECTIVE - BOTANICAL SOOTHING (70764-201)	CONTROL CORRECTIVE SKINCARE INC \| Chemolee Lab Corporation	2025-12-31	HUMAN OTC DRUG LABEL	6