Home NDC 70764-201 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.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# 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 120 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Daily Skin Protection Sunscreen NT ZINC OXIDE SKINPLUSBYOROYO LLC 35a94d6f-9b1c-1b26-e063-6394a90abe65 2025-12-15 Exact identifier application number: M020 Daily Skin Protection Sunscreen NT ZINC OXIDE SKINPLUSBYOROYO LLC 35a9a6ed-c446-c90c-e063-6294a90aaa74 2025-12-15 Exact identifier application number: M020 Daily Skin Protection Sunscreen Tinted ZINC OXIDE SKINPLUSBYOROYO LLC 35a9ecd7-b416-0aab-e063-6294a90a323d 2025-12-15 Exact identifier application number: M020 Proper Protection Plus Primer NT TITANIUM DIOXIDE, ZINC OXIDE Skin & Proper LLC 3596fe93-836b-4f8e-e063-6294a90a674a 2025-12-15 Exact identifier application number: M020 Proper Protection Plus Primer Tinted TITANIUM DIOXIDE, ZINC OXIDE Skin & Proper LLC 359723bb-6152-9566-e063-6294a90a59e0 2025-12-15 Exact identifier application number: M020 Daily Skin Protection Sunscreen Tinted ZINC OXIDE SKINPLUSBYOROYO LLC 35aa194a-9a2e-2b5f-e063-6294a90a9877 2025-12-15 Exact identifier application number: M020 Proper Protection Plus Primer NT TITANIUM DIOXIDE, ZINC OXIDE Skin & Proper LLC 3596cd73-0811-32bc-e063-6394a90ad132 2025-12-15 Exact identifier application number: M020 Proper Protection Plus Primer Tinted TITANIUM DIOXIDE, ZINC OXIDE Skin & Proper LLC 359782d7-6601-7d96-e063-6394a90af9dc 2025-12-15 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE ESTHETICS BY RIKI LLC 37f1b692-0b80-0536-e063-6294a90ae863 2025-12-15 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE ESTHETICS BY RIKI LLC 387d5194-bc12-68c1-e063-6394a90ab152 2025-12-15 Exact identifier application number: M020 Tinted Mineral Sun Protectant TITANIUM DIOXIDE, ZINC OXIDE PANDA PAMPERING LLC 387c23c2-a9f0-f484-e063-6394a90a4104 2025-12-15 Exact identifier application number: M020 Tinted Mineral Sun Protectant TITANIUM DIOXIDE, ZINC OXIDE PANDA PAMPERING LLC 387be96f-8cda-ce02-e063-6394a90abea5 2025-12-15 Exact identifier application number: M020 Serum Lightly Tinted ZINC OXIDE PANDA PAMPERING LLC 387c593b-c65b-62b5-e063-6294a90ac4c2 2025-12-15 Exact identifier application number: M020 Serum Lightly Tinted ZINC OXIDE PANDA PAMPERING LLC 387c9167-638c-1e30-e063-6394a90a9374 2025-12-15 Exact identifier application number: M020 REJUVN8 TITANIUM DIOXIDE, ZINC OXIDE FLEUR DE VIE LLC 37ede476-43b6-a7c8-e063-6294a90a3e8f 2025-12-15 Exact identifier application number: M020 REJUVN8 TITANIUM DIOXIDE, ZINC OXIDE FLEUR DE VIE LLC 37efa5e1-e88e-d251-e063-6394a90a9371 2025-12-15 Exact identifier application number: M020 Non-Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE THE BEAUTY ROOM OC INC 3dd330bf-92e4-3664-e063-6294a90a0475 2025-12-15 Warnings Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE THE BEAUTY ROOM OC INC 3dd37dd1-fd43-7af4-e063-6394a90ae3a0 2025-12-15 Warnings Exact identifier application number: M020 Non-Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE THE BEAUTY ROOM OC INC 3dd3dcab-e9fb-0ef5-e063-6394a90acef1 2025-12-15 Warnings Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE THE BEAUTY ROOM OC INC 3dd40a6a-d52e-ab87-e063-6294a90a966e 2025-12-15 Warnings Exact identifier application number: M020
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