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 335 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Broad Spectrum SPF 30 Sun Stick	BROAD SPECTRUM SPF 30 SUN STICK	Raining Rose, Inc	a35a7973-443b-5247-e053-2a95a90a4459	2023-10-23	Warnings	Exact identifier application number: M020
Cranberry Orange SPF 15 Broad Spectrum Lip Balm	CRANBERRY ORANGE SPF 15 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	a8c3aa41-c9a0-4f64-e053-2995a90a005e	2023-10-23	Warnings	Exact identifier application number: M020
Super Mint SPF 15 Broad Spectrum Lip Balm	SUPER MINT SPF 15 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	a9626a2f-9931-78d2-e053-2995a90ac40f	2023-10-23	Warnings	Exact identifier application number: M020
Spearmint SPF 30 Broad Spectrum Lip Balm	SPEARMINT SPF 30 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	b7b520dc-bae6-614f-e053-2995a90ae677	2023-10-23	Warnings	Exact identifier application number: M020
Citrus SPF 15 Broad Spectrum Lip Balm	CITRUS SPF 15 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	a75d0651-6001-29ce-e053-2a95a90a967f	2023-10-23	Warnings	Exact identifier application number: M020
Coconut Mineral SPF 15 Broad Spectrum Lip Balm	COCONUT MINERAL SPF 15 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	b7b542fa-b0d2-7b33-e053-2995a90a7119	2023-10-23	Warnings	Exact identifier application number: M020
Vanilla SPF 30 Broad Spectrum Lip Balm	VANILLA SPF 30 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	b7b542fa-b0c2-7b33-e053-2995a90a7119	2023-10-23	Warnings	Exact identifier application number: M020
Pineapple Mineral SPF 15 Broad Spectrum Lip Balm	PINEAPPLE MINERAL SPF 15 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	b7c6684f-1122-20c1-e053-2995a90ae6cf	2023-10-23	Warnings	Exact identifier application number: M020
Farmasi CC Cream LIGHT to MEDIUM 02	TITANIUM DIOXIDE	TAN ALIZE KOZMETIK VE TEMIZLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI	28b3fdff-1986-4048-9ed5-a3d784a4014e	2023-10-23	Warnings	Exact identifier application number: M020
Farmasi CC Cream- MEDIUM 03	TITANIUM DIOXIDE	TAN ALIZE KOZMETIK VE TEMIZLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI	65de3c45-8ec2-4d73-8a29-6203d3b47bd7	2023-10-23	Warnings	Exact identifier application number: M020
Farmasi BB Cream- MEDIUM 03	TITANIUM DIOXIDE	TAN ALIZE KOZMETIK VE TEMIZLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI	9102aa2f-0308-4985-b8a8-8e105047b61f	2023-10-23	Warnings	Exact identifier application number: M020
Caribbean Breeze SPF 15 Broad Spectrum Lip Balm	CARIBBEAN BREEZE SPF 15 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	a75a42f6-27d1-e2cc-e053-2a95a90aa6da	2023-10-23	Warnings	Exact identifier application number: M020
Iced Pear SPF 15 Broad Spectrum Lip Balm	ICED PEAR SPF 15 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	a8c4a0ec-e07e-1cda-e053-2a95a90a0f3f	2023-10-23	Warnings	Exact identifier application number: M020
Lemonade SPF 15 Broad Spectrum Lip Balm	LEMONADE SPF 15 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	a8ffc32b-b758-0f8f-e053-2995a90adb62	2023-10-23	Warnings	Exact identifier application number: M020
Strawberry SPF 15 Broad Spectrum Lip Balm	STRAWBERRY SPF 15 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	a902d590-0726-ad6f-e053-2995a90a1130	2023-10-23	Warnings	Exact identifier application number: M020
Orange Creamsicle SPF 15 Broad Spectrum Lip Balm	ORANGE CREAMSICLE SPF 15 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	a9005cb1-ae1a-7736-e053-2995a90a28ea	2023-10-23	Warnings	Exact identifier application number: M020
Neora Age IQ Invisi-Bloc Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Neora, LLC	f2f3601f-081a-4bae-e053-2a95a90a4fac	2023-10-23	Warnings	Exact identifier application number: M020
Neora Age IQ Invisi-Bloc Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Neora, LLC	82f48635-1dc4-8c0d-e053-2991aa0a60cc	2023-10-23	Warnings	Exact identifier application number: M020
Artistry Exact Fit Longwearing Foundation Shade Golden L4N1	TITANIUM DIOXIDE	Amway Corp	7494fe09-40e0-4152-9974-a6e8a4d7f421	2023-10-22	Warnings	Exact identifier application number: M020
Artistry Exact Fit Longwearing Foundation Shade Soleil L3W1	TITANIUM DIOXIDE	Amway Corp	cec51b88-a6b8-4b64-b3aa-830e712a3c8a	2023-10-22	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