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 277 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Equaline Sport Sunscreen SPF 50	AVOBENZONE, HOMOSALATE, OCTOCRYLENE	United Natural Foods, Inc. dba UNFI	f0dda684-b0ed-629c-e053-2995a90a1287	2024-10-16	Warnings	Exact identifier application number: M020
EQUALINE SPORT SUNSCREEN CONTINUOUS SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	United Natural Foods, Inc. dba UNFI	e46d20b3-2897-1370-e053-2a95a90a619c	2024-10-16	Warnings	Exact identifier application number: M020
MEIJER BROAD SPECTRUM SPF 30 SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISLATE, OCTOCRYLENE	MEIJER DISTRIBUTION. INC.	a71d34d4-a924-6421-e053-2995a90a647e	2024-10-16	Warnings	Exact identifier application number: M020
MEIJER BROAD SPECTRUM SPF 50 SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	MEIJER DISTRIBUTION, INC.	a71bf24f-b923-b81f-e053-2995a90a0072	2024-10-16	Warnings	Exact identifier application number: M020
MEIJER KIDS BROAD SPECTRUM SPF 50 MINERAL BASED SUNSCREEN	OCTINOXATE, OCTISALATE, ZINC OXIDE	MEIJER DISTRIBUTION INC	a9f4fd45-3bbb-14a7-e053-2995a90ab28f	2024-10-16	Warnings	Exact identifier application number: M020
WEGMANS SPORT CLEAR CONTINUOUS SUNSCREEN SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	WEGMANS FOOD MARKETS INC	e4b7df52-2bc9-1afc-e053-2a95a90a4f87	2024-10-16	Warnings	Exact identifier application number: M020
Wegmans SPORT BROAD SPECTRUM SPF 30 SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	WEGMANS FOOD MARKETS INC	f12bff9a-bd3c-e35d-e053-2995a90abf17	2024-10-16	Warnings	Exact identifier application number: M020
MINERAL SUNSCREEN SPF 50	ZINC OXIDE, TITANIUM DIOXIDE	WEGMANS FOOD MARKETS INC	bfe24f55-d0e5-254a-e053-2995a90a2fd3	2024-10-16	Warnings	Exact identifier application number: M020
Wegmans Sport Broad Spectrum SPF 70 Clear Continuous Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTCRYLENE	WEGMANS FOOD MARKETS INC	e7175821-e514-1bea-e053-2995a90a0c0d	2024-10-16	Warnings	Exact identifier application number: M020
Wegmans Kids and Sport Broad Spectrum SPF 50 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	WEGMANS FOOD MARKETS INC	f3463f81-9a65-3796-e053-2995a90a4f80	2024-10-16	Warnings	Exact identifier application number: M020
Wegmans Sheer Broad Spectrum SPF 30 Dry Touch Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	WEGMANS FOOD MARKETS INC	f33248fa-695a-fbef-e053-2a95a90abe35	2024-10-16	Warnings	Exact identifier application number: M020
Wegmans Sport Sunscreen Stick SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	WEGMANS FOOD MARKETS INC	f5671251-e26b-045f-e053-2a95a90adc03	2024-10-16	Warnings	Exact identifier application number: M020
Wegmans Kids Sunscreen Stick SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	WEGMANS FOOD MARKETS INC	f57775c3-5e6c-f47a-e053-2a95a90ab012	2024-10-16	Warnings	Exact identifier application number: M020
Sunscreen ULTRA Broad Spectrum Equate	AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE	WAL-MART STORES INC.	68524d2b-284c-4a69-9b0e-8d2ad80822e2	2024-10-16	Warnings	Exact identifier application number: M020
Equate SPF 50 Ultra Sunscreen Continuous	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Wal-Mart Stores Inc	8fda6c78-1b39-6aa6-e053-2995a90a16a2	2024-10-16	Warnings	Exact identifier application number: M020
Equate SPF 70 Ultra Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	Wal-Mart Stores Inc	8f24e301-3fce-f9e3-e053-2a95a90affe4	2024-10-16	Warnings	Exact identifier application number: M020
Equate SPF 50 Ultra Zinc Sunscreen	OCTOCRYLENE, ZINC OXIDE	Wal-Mart Stores Inc	8fdc0bad-8834-5b4a-e053-2a95a90a9fde	2024-10-16	Warnings	Exact identifier application number: M020
Equate SPF 50 Ultra Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Wal-Mart Stores Inc	8f02f297-5315-ced4-e053-2a95a90a8c7b	2024-10-16	Warnings	Exact identifier application number: M020
Equate SPF 70 Ultra Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	Wal-Mart Stores Inc	9b655e56-33e5-45a3-9174-356fc717e39d	2024-10-16	Warnings	Exact identifier application number: M020
Equate Sunscreen SPF 70 SPORT Broad spectrum	AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE	Wal-Mart Stores Inc	e3181725-d04e-4a73-8871-9a1a9a11229c	2024-10-16	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