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 272 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CVS Health SPF 70 Sun	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	CVS Pharmacy	63b420ba-ac69-5670-e053-2a91aa0a864b	2024-10-22	Warnings	Exact identifier application number: M020
CVS Health Ultra Sheer SPF 100 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	CVS PHARMACY	c52a7e9b-5401-f6e7-e053-2995a90a9519	2024-10-22	Warnings	Exact identifier application number: M020
CVS Health Ultra Sheer Broad Spectrum SPF 70	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	CVS Pharmacy	c68c3d6a-b656-abaf-e053-2a95a90a48db	2024-10-22	Warnings	Exact identifier application number: M020
CVS Health Ultra Sheer Broad Spectrum SPF 45 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	CVS Pharmacy	c5e8fcc9-db5c-9ee7-e053-2a95a90ac940	2024-10-22	Warnings	Exact identifier application number: M020
CVS Health SPF 55 Ultra Sheer	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	CVS Pharmacy	c617cdec-b489-22d2-e053-2995a90a1ec6	2024-10-22	Warnings	Exact identifier application number: M020
TRADER JOES ILLUMINATING DAILY FACIAL SUNSCREEN BROAD SPECTRUM SPF 40	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Trader Joe's Company	1b7c2f13-81b8-7af5-e063-6294a90a3501	2024-10-22	Warnings	Exact identifier application number: M020
CVS Health SPF 50 Beach Guard	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	CVS Pharmacy	df25c35d-6b6d-1ef8-e053-2995a90aaef5	2024-10-22	Warnings	Exact identifier application number: M020
CVS Health Kids SPF 50 Clear	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	CVS PHARMACY	e4581d0e-ce6d-7898-e053-2a95a90a02b5	2024-10-22	Warnings	Exact identifier application number: M020
CVS Health SPF 55 Ultra Sheer Face Mist	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	CVS Pharmacy	dfb55b46-e88f-4949-e053-2995a90adabc	2024-10-22	Warnings	Exact identifier application number: M020
CVS Health Sport SPF 30 Clear Broad Spectrum	AVOBENZONE, HOMOSALATE,OCTISALATE,OCTOCRYLENE	CVS PHARMACY	e4589114-87c5-56b8-e053-2995a90a0934	2024-10-22	Warnings	Exact identifier application number: M020
TRADER JOES ENRICH MOISTURIZING FACE BROAD SPECTRUM SPF 15	OCTINOXATE, ZINC OXIDE	Trader Joe's Company	a6805675-916c-4a19-b993-d465fcef58a1	2024-10-22	Warnings	Exact identifier application number: M020
TRADER JOES FACE AND BODY SUNSCREEN SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Trader Joe's Company	057ac99c-60e8-47c1-a32d-984bbd181846	2024-10-22	Warnings	Exact identifier application number: M020
TRADER JOES ZINC OXIDE MINERAL SUNSCREEN SPF 30	ZINC OXIDE	Trader Joe's Company	9e48de83-cb72-4c03-a819-939db8793e1f	2024-10-22	Warnings	Exact identifier application number: M020
TRADER JOES DAILY FACIAL SUNSCREEN SPF 40	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Trader Joe's Company	db3c2210-0e11-0a0e-e053-2a95a90aecbf	2024-10-22	Warnings	Exact identifier application number: M020
Philosophy Hope in a Jar Smooth-glow Multi-tasking Moisturizer Broad Spectrum SPF 30 with Pro-vitamin P, glycolic and hyaluronic acids	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	Philosophy, Inc.	24ffeef6-ca72-5f30-e063-6394a90a41d1	2024-10-21	Warnings	Exact identifier application number: M020
Bali Body BB Cream SPF 15 Natural	OCTOCRYLENE, OCTINOXATE, AVOBENZONE, OXYBENZONE	Bali Body Pty Ltd	db0edf56-4f39-7b48-e053-2a95a90a9b42	2024-10-21	Warnings	Exact identifier application number: M020
Bali Body Tinted Super Serum Natural SPF 30	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Bali Body Pty Ltd	f5eeaf37-33f2-2c0c-e053-2a95a90abcc0	2024-10-21	Warnings	Exact identifier application number: M020
Bali Body BB Cream SPF 15 Tan	OCTOCRYLENE, OCTINOXATE, AVOBENZONE, OXYBENZONE	Bali Body Pty Ltd	db0f6a36-27dd-3301-e053-2995a90aff65	2024-10-21	Warnings	Exact identifier application number: M020
Bali Body Watermelon Tanning Oil SPF 6	OCTOCRYLENE, OCTISALATE, AVOBENZONE	Bali Body Pty Ltd	03705641-feaf-2cbd-e063-6394a90a806e	2024-10-21	Warnings	Exact identifier application number: M020
Bali Body Pineapple Tanning Oil SPF15	OCTOCRYLENE, OCTISALATE, AVOBENZONE	Bali Body Pty Ltd	21c49bbf-97b1-c8c0-e063-6394a90ab412	2024-10-21	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