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 307 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
EA EIGHT HR LIP SHEER TINTS	OXYBENZONE, PADIMATE O, PETROLATUM	REVLON	b671d630-2b71-66d2-e053-2a95a90a8461	2024-01-12	Warnings	Exact identifier application number: M020
Revlon Colorstay Light Cover Foundation	HOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE,ZINC OXIDE	Revlon	b0006b5f-0d56-0efb-e053-2a95a90a5979	2024-01-12	Warnings	Exact identifier application number: M020
PREVAGE CITY SMART	TITANIUM DIOXIDE, ZINC OXIDE	REVLON	b60c9b41-cf32-ee94-e053-2a95a90abab0	2024-01-12	Warnings	Exact identifier application number: M020
CERAMIDE MAKEUP SPF 15	OCTINOXATE, TITANIUM DIOXIDE	REVLON	b3ad9686-47ed-4b60-e053-2995a90abcdd	2024-01-12	Warnings	Exact identifier application number: M020
Aruba Aloe broad spectrum SPF 15 Lip sunscreen and Moisturizer	AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE	Aruba Aloe Balm NV	9e3ed6dc-14ba-4bb2-a633-1a1fe92099ce	2024-01-11	Warnings	Exact identifier application number: M020
Principal Secret Reclaim Botanical (with SP) Radiant Recovery Day Broad Spectrum SPF 15	OCTINOXATE, OCTISALATE, AND ZINC OXIDE	Guthy-Renker LLC	6437fbf6-c84b-497e-bf69-b20153d4c706	2024-01-11	Warnings	Exact identifier application number: M020
I Conceal Flawless Foundation BS SPF 30 Sunscreen SUEDE	ZINC OXIDE AND TITANIUM DIOXIDE	Allure Labs	0e9d006c-2ea0-8228-e063-6394a90a65d6	2024-01-10	Warnings	Exact identifier application number: M020
Principal Secret Reclaim Sunscreen For Face and Body SPF 30	MERADIMATE, OCTINOXATE, OXYBENZONE, AND ZINC OXIDE	Guthy-Renker LLC	4a183aa2-deda-4b26-a126-6f98cfbdb0f3	2024-01-10	Warnings	Exact identifier application number: M020
EVEN BETTER MAKEUP BROAD SPECTRUM SPF 15	OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDE	CLINIQUE LABORATORIES LLC	d4de3c7b-3993-40e5-88a4-f6005ab97531	2024-01-09	Warnings	Exact identifier application number: M020
Principal Secret Reclaim Oil Control hydrator SPF-8	TITANIUM DIOXIDE	Guthy-Renker LLC	97b7cd4e-78aa-418b-a112-263971fa9827	2024-01-08	Warnings	Exact identifier application number: M020
Principal Secret Advanced with Hydrospheres Continuous Moisture SPF8	OCTINOXATE AND OCTISALATE	Guthy-Renker LLC	f4310455-8b3f-40a9-8674-fe7fc3abaced	2024-01-08	Warnings	Exact identifier application number: M020
Aruba Sun SPF 30 Sunscreen	AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 6%	Derma Care Research Labs,LLC	d8b4f8c4-811b-4139-e053-2995a90a04c2	2024-01-05	Warnings	Exact identifier application number: M020
MIAMI BEACH BUM Save Face Sheer Mineral Sunscreen SPF 50	ZINC OXIDE	MIAMI BEACH BUM	95675bd2-a0ae-44db-a75a-5c432e961495	2024-01-04	Warnings	Exact identifier application number: M020
GINZING SPF 30 DAILY MOISTURIZER	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	ORIGINS NATURAL RESOURCES INC.	0e106c03-4c25-5bfb-e063-6294a90ab3e1	2024-01-03	Warnings	Exact identifier application number: M020
Avon Anew Platinum Day-Cream SPF 25 Sunscreen	AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE	The Avon Company	148203ef-7d73-369c-e063-6394a90a0e58	2024-01-03	Warnings	Exact identifier application number: M020
Avon Anew Ultimate Day Multi-Performance-Cream SPF 25 Sunscreen	AVOBENZONE, HOMOSALATE, OCTINOXATE, OXYBENZONE	The Avon Company	14833e71-704d-9a88-e063-6394a90a31b2	2024-01-03	Warnings	Exact identifier application number: M020
Prime Time Daily Protecting Primer SPF 30	SPF 30 PRIME TIME PRIMER	Autumn Harp Inc.	f2619092-3e7f-5105-e053-2a95a90a3f5a	2024-01-03	Warnings	Exact identifier application number: M020
ARTISTRY IDEAL RADIANCE UV Protect SPF 50 PLUS Broad Spectrum Sunscreen	OCTINOXATE, OCTISALATE, ZINC OXIDE, TITANIUM DIOXIDE	Amway Corp	a1a700b5-d039-4bd2-8420-5c2053095706	2024-01-02	Warnings	Exact identifier application number: M020
Garnier green labs Replumping HyaluMelon Broad Spectrum SPF 30 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	LOreal USA Products Inc	5bece3c9-c310-4fb2-b644-507407fcfb08	2024-01-02	Warnings	Exact identifier application number: M020
Josie Maran Argan Daily Moisturizer SPF47 Protect and Perfect	ZINC OXIDE, TITANIUM DIOXIDE	Autumn Harp, Inc.	cb91c130-45d4-46a0-9628-50e701a6960c	2024-01-02	Boxed warning, 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