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 231 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
JAFRA Beauty advanced SILK MOISTURIZING SERUM FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 RICH COCOA ND20	HOMOSALATE, OCTISALATE, ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	2e307ca4-9975-47ef-b13f-2cfbcc846719	2025-02-03	Warnings	Exact identifier application number: M020
JAFRA Beauty advanced SILK MOISTURIZING SERUM FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 CAPUCCINO D8	HOMOSALATE, OCTISALATE, ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	08628240-327d-4329-a0ff-fed239dde206	2025-02-03	Warnings	Exact identifier application number: M020
JAFRA Beauty advanced SILK MOISTURIZING SERUM FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 NATURAL LG14	HOMOSALATE, OCTISALATE, ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	768100d6-efd6-4a98-bdb8-2d1561ee356c	2025-02-03	Warnings	Exact identifier application number: M020
JAFRA Beauty advanced SILK MOISTURIZING SERUM FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 IVORY LN18	HOMOSALATE, OCTISALATE, ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	e6f33ec7-691f-4d4b-9086-b981c19f80d3	2025-02-03	Warnings	Exact identifier application number: M020
JAFRA Beauty advanced SILK MOISTURIZING SERUM FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 SUNTAN MDG14	HOMOSALATE, OCTISALATE, ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	784bb8c4-ee3c-4a73-a828-5781f01f621d	2025-02-03	Warnings	Exact identifier application number: M020
Brush On Block SPF 30 Mineral Powder Translucent Zinc Only-Refill	ZINC OXIDE	SPF Ventures, LLC	2d47eb76-e644-4e04-e063-6294a90a93cc	2025-02-03	Warnings	Exact identifier application number: M020
Brush On Block Sun Shine SPF 30 Protective Lip Oil Peony Tint	TITANIUM DIOXIDE/ZINC OXIDE	SPF Ventures LLC	2d490531-af36-87d0-e063-6394a90acf49	2025-02-03	Warnings	Exact identifier application number: M020
YOUR TINTED MOISTURIZER HYDRATING ANTI AGING BROAD SPECTRUM SPF 30	OCTISALATE, OCTINOXATE, OXYBENZONE, AVOBENZONE	Skin Ai, LLC	2d8b7d07-2249-898b-e063-6394a90af6ad	2025-02-01	Warnings	Exact identifier application number: M020
ESSENCE LIGHT SUNSCREEN SPF 50 PA	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	ENGLEWOOD LAB, INC.	f5c79f1a-cecd-2409-e053-2995a90ad06f	2025-01-31	Warnings	Exact identifier application number: M020
RODAN - FIELDS ESSENTIALS Body Sunscreen BROAD SPECTRUM SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Rodan & Fields	67b55df8-9623-4352-b136-b0bc8d1efe02	2025-01-31	Warnings	Exact identifier application number: M020
Oil-Free Daily Hydration SPF 15	OCTINOXATE, AVOBENZONE	Boscia LLC	ec322ae5-ab03-4c7b-9c6d-0bda3327c72a	2025-01-31	Warnings	Exact identifier application number: M020
PAULAS CHOICE HYDRALIGHT SHINE-FREE DAILY MINERAL COMPLEX Broad Spectrum SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Paula's Choice, Inc	b90658d0-e422-4265-a6ee-39c29b6c116a	2025-01-31	Warnings	Exact identifier application number: M020
SunStation USA SPF-30 SPORT SUNSCREEN	ZINC OXIDE	RENU LABORATORIES, LLC	11d3c60e-238d-999e-e063-6394a90a624b	2025-01-31	Warnings	Exact identifier application number: M020
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF30	TITANIUM DIOXIDE AND ZINC OXIDE	DERM ASSO. MID OHIO	2d04bc5d-6f11-4f56-e063-6294a90ae755	2025-01-31	Warnings	Exact identifier application number: M020
TiZO Mineral Sun Defense SPF 50	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals Ltd.	2d0766a1-4091-e84a-e063-6394a90a004a	2025-01-31	Warnings	Exact identifier application number: M020
Hello Sunday The Shimmer One Mineral Glow SPF 45	ZINC OXIDE	Kao USA Inc.	0c935521-4e8b-0605-e063-6394a90a0bbc	2025-01-31	Warnings	Exact identifier application number: M020
Hello Sunday The Invisible One Sunscreen Plus Primer SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Kao USA Inc.	0c7ce5b9-5ab4-d845-e063-6394a90afa76	2025-01-31	Warnings	Exact identifier application number: M020
Hello Sunday The Mineral One Lightweight Serum SPF 50	ZINC OXIDE	Kao USA Inc.	0c91894f-a40e-73e9-e063-6394a90ab807	2025-01-31	Warnings	Exact identifier application number: M020
Hello Sunday The One Thats a Serum Hydrating Serum SPF 45	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Kao USA Inc.	0c913096-c000-4336-e063-6394a90a560c	2025-01-31	Warnings	Exact identifier application number: M020
Hello Sunday Bestseller Daily SPF Duo	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Kao USA Inc.	26cf264b-f68d-5691-e063-6394a90a8ab4	2025-01-31	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