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 50 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sky and Sol Face and Body Sunscreen SPF 50	NON- NANO ZINC OXIDE	Delta Ecommerce LLC	473a6ade-1f0a-c711-e063-6294a90a2b83	2026-03-30	Warnings	Exact identifier application number: M020
Vacation by Vacation Scent and Shimmer Duo	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Vacation Inc.	0c4e6fa1-c78d-4f9d-969f-135d4ed67daf	2026-03-30	Warnings	Exact identifier application number: M020
Marie originals - ProActive Sunscreen	ZINC OXIDE SUNSCREEN	VEGANIC SKN LIMITED	4e3204bf-eda4-2bdf-e063-6394a90ae429	2026-03-29	Warnings	Exact identifier application number: M020
Sport Ultra	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	CARDINAL HEALTH 110, LLC. DBA LEADER	37c5dcf7-dc2d-624f-e063-6394a90ae992	2026-03-29	Warnings	Exact identifier application number: M020
ULTRALIGHT AGE DEFENSE SPF 50	ZINC OXIDE	Guangzhou Origin Beauty Cosmetics Co., Ltd.	4e36a743-7906-2b7b-e063-6294a90af314	2026-03-29	Warnings	Exact identifier application number: M020
Stay Put Sunscreen SPF 30	OCTINOXATE 7.50% OCTISALATE 5.00% OXYBENZONE 4.00% HOMOSALATE 10.00%	Sawyer Products Inc	7ecba495-a912-4697-8287-2e5836e610e1	2026-03-27	Warnings	Exact identifier application number: M020
UV SOLUTIONS BRIGHTENING TINTED BROAD SPECTRUM SPF 50 SUNSCREEN NIACINAMIDE ANTIOXIDANTS DARK SHADE	TITANIUM DIOXIDE AND ZINC OXIDE	CLINIQUE LABORATORIES LLC	4e0bd355-99c6-8cf4-e063-6294a90ab4b3	2026-03-27	Warnings	Exact identifier application number: M020
Vacation X AZ Lemon Tea Lip Balm SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Vacation INC.	61c48acc-f589-40d3-b289-b777db5551db	2026-03-27	Warnings	Exact identifier application number: M020
Truly Solar Baby Suncreen SPF 45	HOMOSALATE 15% OCTISALATE 5% OCTOCRYLENE 10% AVOBENZONE 3%	Truly Beauty, Inc	38e6c6fc-d8b9-4196-96c7-0f6d5d06da02	2026-03-26	Warnings	Exact identifier application number: M020
burnd	HOMOSALATE, OCTINOXATE, ZINC OXIDE	BURND LLC	31cf923e-fdde-790b-e063-6294a90a60ee	2026-03-26	Warnings	Exact identifier application number: M020
SUNNYSIDEKICK UVA/UVB Broad Spectrum SPF 30 Brush-On Mineral	ZINC OXIDE, TITANIUM DIOXIDE	Classic Cosmetics LLC	4df3b8c0-71bc-acdd-e063-6394a90a35c0	2026-03-26	Warnings	Exact identifier application number: M020
COSRX	VITAMIN E VITALIZING SUNSCREEN	COSRX inc.	4df77564-9da0-7e48-e063-6294a90a5e6b	2026-03-26	Warnings	Exact identifier application number: M020
Mentholatum Natural Ice Protect Plus SPF 30 Protect Plus SPF 30	AVOBENZONE, DIMETHICONE, OCTINOXATE, OCTISALATE	The Mentholatum Company	3804a14b-be7c-a973-e063-6294a90ac7fc	2026-03-25	Warnings	Exact identifier application number: M020
Softlips Oasis Pineapple Coconut	DIMETHICONE, OXYBENZONE, OCTINOXATE	The Mentholatum Company	c504463a-28bf-4161-875f-ef73520931c5	2026-03-25	Warnings	Exact identifier application number: M020
Mentholatum Natural Ice Cherry, SPF 15 Cherry	DIMETHICONE, OCTINOXATE, OCTISALATE	The Mentholatum Company	37f2c3a6-7790-c8ec-e063-6294a90ace22	2026-03-25	Warnings	Exact identifier application number: M020
Mentholatum Natural Ice - Original, SPF 15 Original	DIMETHICONE, OCTINOXATE, OCTISALATE	The Mentholatum Company	37dc44aa-17b2-8721-e063-6294a90a34f6	2026-03-25	Warnings	Exact identifier application number: M020
ISNTREE HYALURONIC ACID DAILY SUNGEL	AVOBENZONE, HOMOSALATE, OCTISALATE	ISNTREE Inc.	0ef5d5ce-3bdf-dffc-e063-6394a90aad54	2026-03-25	Warnings	Exact identifier application number: M020
Silkscreen Sheer Tint Mineral Light-Medium	TITANIUM DIOXIDE, ZINC OXIDE	Curology	4ddbe349-6880-a5fc-e063-6294a90a275c	2026-03-25	Warnings	Exact identifier application number: M020
AXIS-Y Complete No-Stress Physical Sunscreen V.3	ZINC OXIDE	Asia Master Trade Co.,Ltd	1f310fb1-185a-b467-e063-6294a90a72fe	2026-03-25	Warnings	Exact identifier application number: M020
BANANA BOAT	TITANIUM DIOXIDE,ZINC OXIDE	Edgewell Personal Care Brands LLC	4e0450ca-147a-91d7-e063-6394a90ae73b	2026-03-25	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