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 224 of 353 · 7,041 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Neutrogena pure and free baby SUNSCREEN Broad Spectrum SPF 50 ZINC OXIDE Kenvue Brands LLC 2d2c58e2-0d15-4383-adae-12fc17b8ea50 2025-03-20 Warnings Exact identifier application number: M020 Neutrogena Ultra Sheer Face and Body Sunscreen Broad Spectrum SPF 50 ZINC OXIDE Kenvue Brands LLC 1907126c-fd95-86e8-e063-6394a90a23ca 2025-03-20 Warnings Exact identifier application number: M020 Neutrogena Sheer Zinc Kids Mineral Sunscreen Broad Spectrum SPF 50 Plus ZINC OXIDE Kenvue Brands LLC 4504a10d-6130-4ec5-823a-ab970709e6d7 2025-03-20 Warnings Exact identifier application number: M020 Vertra Mineral Sunscreen Broad Spectrum SPF 50 ZINC OXIDE Eai-jr 286, Inc 30caf1dd-142d-85d3-e063-6394a90a0c88 2025-03-20 Warnings Exact identifier application number: M020 Sun Shades Lip Balm Cranberry Tangerine AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3% Melaleuca Inc. f39606be-19c8-58d1-e053-2a95a90a908f 2025-03-20 Warnings Exact identifier application number: M020 Obagi Medical Back to Basics (Including Obagi Medical Professional-C Serum 15) HOMOSALATE, OCTISALATE, AND ZINC OXIDE Obagi Cosmeceuticals LLC aa937596-2378-469f-a0e1-9700044e83b3 2025-03-20 Warnings Exact identifier application number: M020 Obagi Medical Way to Glow Kit HOMOSALATE, OCTISALATE, AND ZINC OXIDE Obagi Cosmeceuticals LLC f6f6e219-4ef6-be3b-e053-6294a90a660d 2025-03-20 Warnings Exact identifier application number: M020 Obagi Medical Back to Basics (Including Obagi Medical Professional-C Serum 20) HOMOSALATE, OCTISALATE, AND ZINC OXIDE Obagi Cosmeceuticals LLC e8d19915-8996-42df-a47b-2ce00d2bbe68 2025-03-20 Warnings Exact identifier application number: M020 SHISEIDO URBAN ENVIRONMENT Oil-Free SUNSCREEN SPF 42 ENSULIZOLE, HOMOSALATE, OCTISALATE, AND ZINC OXIDE SHISEIDO AMERICAS CORPORATION 21bde283-a554-45c8-8733-2a8adeff41b1 2025-03-20 Warnings Exact identifier application number: M020 SHISEIDO ULTIMATE SUN PROTECTOR OCTISALATE, HOMOSALATE, OCTOCRYLENE, AND AVOBENZONE SHISEIDO AMERICAS CORPORATION 7a98171f-bf21-40d4-bc78-883aa0b0c438 2025-03-20 Warnings Exact identifier application number: M020 Carmex Variety Pack Daily Care Sticks Moisturizing Lip Balm SPF 15 OCTINOXATE, OXYBENZONE Carma Laboratories, Inc. 5e2d7c94-d70a-47e4-9a4b-5953fe38ede2 2025-03-19 Warnings Exact identifier application number: M020 Carmex Variety Pack Daily Care Sticks Moisturizing Lip Balm SPF 15 OCTINOXATE, OXYBENZONE Carma Laboratories, Inc. 50206f9e-2dd5-494f-9eed-f7d7ea6efda9 2025-03-18 Warnings Exact identifier application number: M020 Hello Sun Silky Glow Broad Spectrum SPF40 ZINC OXIDE The Creme Shop 30a4280b-4a9f-4c18-e063-6394a90a85e6 2025-03-18 Warnings Exact identifier application number: M020 Vertra Invisible Sunscreen Face Stick Broad Spectrum SPF 45 ZINC OXIDE Eai-jr 286, Inc 30a5ec14-63d7-e678-e063-6294a90abb57 2025-03-18 Warnings Exact identifier application number: M020 EXTRASHADE Daily Defense Hydrating Sunscreen SPF 30 AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE Extra Shade, LLC d197dfe3-c754-4a3d-9edd-335f3fce105c 2025-03-18 Warnings Exact identifier application number: M020 Lancome Paris UV Expert Aquagel Defense 50 Plus Sunscreen Broad Spectrum SPF 50 Plus Primer and Moisturizer AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE L'Oreal USA Products Inc c88e44da-0b0e-4744-8b4b-4d9d418f29d7 2025-03-18 Warnings Exact identifier application number: M020 MDP UV BIO SUNSCREEN ZINC OXIDE, HOMOSALATE, OCTOCRYLENE, OCTISALATE SKINIDEA CO., LTD 3087771e-2ab8-2198-e063-6294a90a37d4 2025-03-17 Warnings Exact identifier application number: M020 belif Dew guard - milky sun serum Broad Spectrum SPF 40 sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LG H&H CO., LTD. 2b38da59-b83e-4285-e063-6294a90ac6a7 2025-03-17 Warnings Exact identifier application number: M020 SUN SHIELD BROAD SPECTRUM SPF 50 MATTE SUNSCREEN HOMOSALATE, OCTISALATE, AND ZINC OXIDE Obagi Cosmeceuticals LLC 263ef8e8-e0c4-42e6-bb26-7581a437b35a 2025-03-14 Warnings Exact identifier application number: M020 Impact Melanoma SPF 30 ZINC OXIDE RENU LABORATORIES, LLC f953302e-f712-129a-e053-6294a90ab9a8 2025-03-13 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