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 164 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SOME BY MI V10 HYAL AIR FIT SUNSCREEN	SUNSCREENT	PERENNEBELL	fe2148db-9020-9343-e053-6294a90adf70	2025-11-13	Warnings	Exact identifier application number: M020
skin MD	OCTINOXATE, OCTISALATE, HOMOSALATE	21st Century Formulations	e809e1d3-0a6d-730d-e053-2a95a90aedb9	2025-11-13	Warnings	Exact identifier application number: M020
Obagi Nu-Derm Fx System Normal-Oily Skin Transformation Complexion Brightening System	TITANIUM DIOXIDE, ZINC OXIDE	Obagi Cosmeceuticals LLC	a64045dd-8f70-43f1-be6f-ad1556c0e210	2025-11-13	Warnings	Exact identifier application number: M020
Florida Glow SPF 50	AVOBENZONE,OCTOCRYLENE,OCTISALATE,HOMOSALATE	Southeast Holdings Corp.	dcb43ee0-5ab0-495a-8e68-90cab881337d	2025-11-12	Warnings	Exact identifier application number: M020
Florida Glow SPF 30	AVOBENZONE,OCTOCRYLENE,OCTISALATE,HOMOSALATE	Southeast Holdings Corp.	20538bc0-10c3-492c-952a-6797e46003f2	2025-11-12	Warnings	Exact identifier application number: M020
Florida Glow SPF 15	AVOBENZONE,OCTOCRYLENE,OCTISALATE	Southeast Holdings Corp.	56af704a-bda9-49ed-a177-a8480d90458b	2025-11-12	Warnings	Exact identifier application number: M020
Florida Glow face shield SPF 55	HOMOSALATE, OCTOCRYLENE, ZINC OXIDE	Southeast Holdings Corp.	cea54600-5308-4b9f-98ca-fef0b26d79c1	2025-11-12	Warnings	Exact identifier application number: M020
Florida Glow SPF 30	ZINC OXIDE	Southeast Holdings Corp.	4bf1ca6b-5d87-40ee-97f4-89f1bfadcecb	2025-11-12	Warnings	Exact identifier application number: M020
TuroSkin Daily Moisturizing Sunscreen broadspectrum spf15	AVOBENZONE,HOMOSALATE,OCTISALATE	Renuskin LLC	e36efd74-11c2-4850-9529-1c88b7364a33	2025-11-12	Warnings	Exact identifier application number: M020
TuroSkin Sport Sunscreen Broad Spectrum SPF 30 WR SR 80min	AVOBENZONE,HOMOSALATE,OCTISALATE	Renuskin LLC	22a40d93-ca67-4b7d-a95c-22f52cd6d297	2025-11-12	Warnings	Exact identifier application number: M020
ZEUS	ZINC OXIDE	NEWPORT APOTHECARY, INC	5354c383-08f0-4b89-b36a-96a35f47be3c	2025-11-12	Warnings	Exact identifier application number: M020
Practical Alchemy Hydrating SPF 30	ZINC OXIDE	Over Here, LLC	2f07df5b-dbd4-494c-a7cf-55843fb4d7c2	2025-11-12	Warnings	Exact identifier application number: M020
Dr Lift SPF 50 Mineral Sunscreen Stick	ZINC OXIDE	Spa de Soleil	436fdf4f-11db-7c5b-e063-6294a90a8731	2025-11-12	Warnings	Exact identifier application number: M020
CeraVe Developed with Dermatologists Skin Renewing Brightening with Sunscreen Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	L'Oreal USA Products Inc	3676aa91-c90d-4a7a-b02e-d5b35304a04d	2025-11-12	Warnings	Exact identifier application number: M020
HYDRATING GLOW MIST SPF 50	AVOBENZONE, OCTISALATE, OCTOCRYLENE	NAKED SUNDAYS PTY LTD	df3bd18d-63b4-460f-bf1c-115ad35edd96	2025-11-11	Warnings	Exact identifier application number: M020
Zinka Clear Zinc Oxide Sunscreen	OCTINOXATE, ZINC OXIDE, OCTISALATE, OXYBENZONE	Zinka, Inc.	7b097f5e-8127-49e6-8a77-4ee1fded5ff1	2025-11-11	Warnings	Exact identifier application number: M020
Total Sun Protection	OCTINOXATE, OCTISALATE, OXYBENZONE, ZINC OXIDE	Cosmed Dermaceuticals, Inc.	dbb16ef1-ab8c-4e71-a2a2-a507d104ff0f	2025-11-11	Warnings	Exact identifier application number: M020
Sunsorb Reef Safe SPF15	HOMOSALATE, OCTOCRYLENE, AVOBENZONE	QS Key West Aloe, LLC	1a1c17c4-4912-4573-9f59-cbd14a014cb4	2025-11-11	Warnings	Exact identifier application number: M020
Sunsorb Reef Safe SPF30	HOMOSALATE, OCTOCRYLENE, AVOBENZONE	QS Key West Aloe, LLC	14f65b3d-90bf-4689-aa6e-879e06153db9	2025-11-11	Warnings	Exact identifier application number: M020
Sunsorb Reef Safe SPF50	HOMOSALATE, ZINC OXIDE, OCTOCRYLENE	QS Key West Aloe, LLC	b4fc7a51-a163-4057-8790-f2111668ec67	2025-11-11	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