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 91 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join HELLO SUNDAY THE MINERAL LIP ONE NOURISHING LIP TINT SPF 45 BERRY BALMY ZINC OXIDE Kao USA Inc. 26bcb9cd-bfb5-998c-e063-6394a90ab9d6 2026-01-05 Warnings Exact identifier application number: M020 HELLO SUNDAY THE MINERAL LIP ONE NOURISHING LIP TINT SPF 45 VANILLA CLOUD ZINC OXIDE Kao USA Inc. 26cf1320-aae5-2ea0-e063-6394a90a3be2 2026-01-05 Warnings Exact identifier application number: M020 OZE SUN BONDI ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 47b1aae6-0b86-7d48-e063-6294a90a9ece 2026-01-05 Warnings Exact identifier application number: M020 Hybrid SPF SPF 30 OCTOCRYLENE, OCTISALATE, ZINC OXIDE Topiderm, Inc. 5c99f98c-025c-4886-824f-af968033baf4 2026-01-05 Warnings Exact identifier application number: M020 TRICK AND TREAT CC2 - Active Moisturizing Color Correcting Broad-Spectrum SPF 46 Plus TITANIUM DIOXIDE HEY HONEY INC. 21187805-fae9-476c-81b0-27ffeb0b9911 2026-01-05 Warnings Exact identifier application number: M020 VEAKSON BEEF TALLOW SUNSCREEN ZINC OXIDE,PHENYLBENZIMIDAZOLE SULFONIC ACID Guangdong Aimu Biological Technology Co., Ltd 473c241a-1258-1680-e063-6394a90a7d98 2026-01-04 Warnings Exact identifier application number: M020 HYDRATING SUNSCREEN HYDRATING SUNSCREEN Guangzhou Yapeng Refinement Chemical Co., Ltd. 19a3687b-32b0-7c83-e063-6294a90aaf81 2026-01-04 Warnings Exact identifier application number: M020 Bellas Friends Sunscreen Stick ZINC OXIDE Panergytek Usa Inc 478cbdeb-28e4-fa56-e063-6294a90af124 2026-01-04 Warnings Exact identifier application number: M020 Bellas Friends Roll-on Sunscreen TITANIUM DIOXIDE, ZINC OXIDE PANERGYTEK USA INC 478d46ce-14e8-2231-e063-6394a90a3e27 2026-01-04 Warnings Exact identifier application number: M020 Ava Isa Sun Lip Sun Whip Clear Sunshine ZINC OXIDE Cyberderm Laboratories inc. a8646ee4-5e6e-6cdd-e053-2a95a90aee77 2026-01-01 Warnings Exact identifier application number: M020 Ava Isa Sun Lip Sun Whip Strawberry Zinnia ZINC OXIDE Cyberderm Laboratories inc. a888396f-489f-7e7c-e053-2995a90aee5b 2026-01-01 Warnings Exact identifier application number: M020 Ava Isa Sun Lip Sun Whip Watermelon Lily ZINC OXIDE Cyberderm Laboratories inc. a8889754-8e33-4d2a-e053-2995a90a6080 2026-01-01 Warnings Exact identifier application number: M020 OKeeffes Lip Repair AVOBENZONE, DIMETHICONE, OCTINOXATE, OCTOCRYLENE The Gorilla Glue Company/O'Keeffe's Company 6805b3e9-77cb-bfee-e053-2991aa0a8d98 2026-01-01 Warnings Exact identifier application number: M020 Walgreens 50 Pina Colada Scented Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE WALGREEN COMPANY 4978c811-be34-9fc3-e063-6394a90a2d80 2026-01-01 Warnings Exact identifier application number: M020 Unicorn Snot 35 SPF Glitter Spritz rose gold shimmer AVOBENZONE, OCTISALATE, OCTOCRYLENE Jailbreak Toys, Inc. DBA UNICORN SNOT 498b7c1a-e66d-9736-e063-6394a90a4712 2026-01-01 Warnings Exact identifier application number: M020 No7 Lift and Luminate Triple Action Day Cream SPF 30 AVOBENZONE, OCTISALATE, OCTOCRYLENE BCM Ltd f7d5aa8a-9f4a-426b-ac9d-9690cf0103e0 2026-01-01 Warnings Exact identifier application number: M020 MAUI ISLAND SECRET BROWNING CREME Broad Spectrum Sunscreen SPF 5 ZINC OXIDE Formula 7venz L.L.C. 5f3cdec9-2cc2-4660-827f-d286883d907c 2025-12-31 Warnings Exact identifier application number: M020 SOLARA SUNCARE - GO VACATION GLOW SPF 30 ZINC OXIDE SOLARA SUNCARE, INC. 1f5cb694-f065-7ebc-e063-6394a90a883a 2025-12-31 Warnings Exact identifier application number: M020 SUNSCREEN GLOWING, SPF 30 SUNSCREEN GLOWING LOTION FSA Store Inc 473bcb90-ab7f-170b-e063-6294a90a99d5 2025-12-31 Warnings Exact identifier application number: M020 HAWAIIAN TROPIC AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE Edgewell Personal Care Brands LLC 05ba5966-f0ff-5360-e063-6294a90a0fc9 2025-12-31 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