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

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
IngredientStrength
OCTINOXATE6.9 g/100mL
OCTISALATE3 g/100mL
ZINC OXIDE4 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4Y5P7MUD51, 4X49Y0596W, SOI2LOH54Z

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
16a2c1cd-ae95-d910-f03d-7e06b11dd243Product name520260202
653485de-0601-41e4-82db-7a60bb223e27Product name120251024
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
23fb3cda-2b50-f3d3-ebde-f542350bd77bProduct name420240828
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
081b54f0-4545-48b6-b854-03e1401f09eaProduct name120230112
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
aead65a2-216e-4ff8-a178-44aab77c24edProduct name120180531
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70764-201-22BOTANICAL SOOTHINGSPF-3074 mL in 1 BOTTLECREAM746
70764-201-52BOTANICAL SOOTHINGSPF-301 in 1 BOXCREAM16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70764-201BOTANICAL SOOTHING SPF-30 (OCTINOXATE, OCTISALATE, ZINC OXIDE) CREAM [CONTROL CORRECTIVE SKINCARE INC]5Current NDC, Legacy NDC, 2 package rows20230923_00a923fe-e6da-420e-a705-4773ecc2176b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70764-201-227076402012274 mL in 1 BOTTLE74 mlHistorical
70764-201-52707640201521 BOTTLE in 1 BOX (70764-201-52) / 74 mL in 1 BOTTLE (70764-201-22) 1 bottle2016-06-080000-00-00NoNoCurrent