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 36 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
White Mint SPF 15 Broad Spectrum Lip Balm	WHITE MINT SPF 15 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	50ff8c38-94f1-f589-e063-6294a90a5ba8	2026-05-04	Warnings	Exact identifier application number: M020
Surface Sun SPF 50 Mineral	ZINC OXIDE	Surface Products Corp	cabaf7e1-b940-4d6e-b21b-d99c3a4047a7	2026-05-04	Warnings	Exact identifier application number: M020
SPF 50 Dry Touch Continuous No fragrance	HOMOSALATE 10.00% OCTISALATE 5.00% AVOBENZONE 3.00%	Surface Products Corp	503d6b48-3516-4264-9fe8-71a9939669fe	2026-05-04	Warnings	Exact identifier application number: M020
Surface SPF 50 3oz Tinted mineral sunscreen with Water Resistance	ZINC OXIDE	Surface Products Corp	02b770cf-7351-444b-b2c8-ad112e9bea3e	2026-05-04	Warnings	Exact identifier application number: M020
SPF 30 Dry Touch Continuous No fragrance	HOMOSALATE 10.00% OCTISALATE 5.00% AVOBENZONE 3.00%	Surface Products Corp	d13c9e6e-a5da-4691-8792-9d6025e166d7	2026-05-04	Warnings	Exact identifier application number: M020
LUMINOUS EYE CORRECTOR SPF 41 - MEDIUM	TITANIUM DIOXIDE, ZINC OXIDE	Drmtlgy, LLC	0206c676-c24d-470e-adb2-7cb3173f3727	2026-05-04	Warnings	Exact identifier application number: M020
LUMINOUS EYE CORRECTOR SPF 41 - TAN	TITANIUM DIOXIDE, ZINC OXIDE	Drmtlgy, LLC	5c5aad09-9f93-4634-8db1-c67570b38b2b	2026-05-04	Warnings	Exact identifier application number: M020
OBGE PORE-ZERO Oil CONTROL SUN Stick	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	Adapt Inc.	67209e46-1b7a-42df-b31f-fcb3cefbd7e1	2026-05-03	Warnings	Exact identifier application number: M020
Equate	OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE	WALMART INC	2617e5bc-27a2-f187-e063-6394a90a6980	2026-05-03	Warnings	Exact identifier application number: M020
THANK YOU FARMER Sun Project Rice Tinted Mineral Sun Cream	ZINC OXIDE	THANK YOU FARMER CO., LTD	20a44597-3d44-f0ea-e063-6294a90a903d	2026-05-03	Warnings	Exact identifier application number: M020
Ultra Violette Sheen Screen Hydrating Lip Balm Last Bite Broad Spectrum SPF 50	AVOBENZONE, OCTISALATE, OCTOCRYLENE	Grace and Fire USA Inc.	4df3e90e-98a0-edbf-e063-6394a90ae3c9	2026-05-01	Warnings	Exact identifier application number: M020
Ultra Violette Sheen Screen Hydrating Lip Balm Silk Pillow Broad Spectrum SPF 50	AVOBENZONE, OCTINOXATE, OCTOCRYLENE	Grace and Fire USA Inc.	4df6d28b-64ce-59b3-e063-6394a90a6360	2026-05-01	Warnings	Exact identifier application number: M020
EXTREME PROTECT SPF 30	OCTINOXATE, ZINC OXIDE	SCIENCE OF SKINCARE LLC	ecc4d304-e7e2-45b6-b9b2-2c64d3630860	2026-05-01	Warnings	Exact identifier application number: M020
Blue Lizard Sport SPF 50 Sunscreen	OCTISALATE AND TITANIUM DIOXIDE AND ZINC OXIDE	Crown Laboratories	4955fa1c-789d-4f42-af75-70223310644a	2026-05-01	Warnings	Exact identifier application number: M020
Blue Lizard Kids SPF 50 Sunscreen	OCTISALATE AND TITANIUM DIOXIDE AND ZINC OXIDE	Crown Laboratories	ba4ae906-48c0-8384-e053-2995a90afb91	2026-05-01	Warnings	Exact identifier application number: M020
Sun Shield Mineral UV Barrier Protect Broad Spectrum SPF 40 Sunscreen	ZINC OXIDE	Obagi Cosmeceuticals LLC	54a3f855-48de-4ae0-b1f0-e95739853065	2026-05-01	Warnings	Exact identifier application number: M020
MEDICUBE PDRN HYDRATING UV SERUM	HOMOSALATE, OCTOCRYLENE, OCTISALATE, ENSULIZOLE	APR US INC	50a73981-985a-0a70-e063-6394a90a89cf	2026-04-30	Warnings	Exact identifier application number: M020
Sky and Sol Body Sunscreen	NON- NANO ZINC OXIDE	Delta Ecommerce LLC	2ddaa628-0e81-c8a7-e063-6394a90a84f4	2026-04-30	Warnings	Exact identifier application number: M020
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 2CR Cool Rosy	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	6831832a-e52e-43ea-899f-f5d44bea5a94	2026-04-30	Warnings	Exact identifier application number: M020
Carmex 10 count variety pack Lip Balm	OCTINOXATE, OXYBENZONE, CAMPHOR (SYNTHETIC), WHITE PETROLATUM	Carma Laboratories, Inc.	9c5168d5-31ed-4ce1-b16a-5f51f7e44ed2	2026-04-30	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