FDA.reportPublic FDA data

BOTANICAL SOOTHING

Manufacturer
CONTROL CORRECTIVE SKINCARE INC | Chemolee Lab Corporation
Effective date
2025-12-31
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:29:43

Label at a glance#

ProductBOTANICAL SOOTHING SPF-30
Active ingredientOCTINOXATE, OCTISALATE, ZINC OXIDE
Label structure10 sections

Dosage and administration

APPLY GENEROUSLY WITH FINGERS TO ENTIRE FACE AND NECK. USE DAILY.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

OCTINOXATE (6.9%)

OCTISALATE (3.0%)

ZINC OXIDE (4.0%)

PURPOSE

OTC - PURPOSE SECTION

SUNSCREEN

USE

INDICATIONS & USAGE SECTION

A SOOTHING, CALMING AND HYDRATING MOISTURIZER IN ONE. ALSO HELPS TO REDUCE THE APPEARANCE OF SKIN FLUSHING, REDNESS AND VASCULAR STIMULATION. CONTAINING SPF 30 TO FIGHT THE SIGNES OF AGING. A MUST FOR THOSE SUFFERING WITH SKIN AND SUN SENSITIVITIES.

WARNING

WARNINGS SECTION

FOR EXTERNAL USE ONLY. WHEN USING THIS PRODUCT, AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE THOROUGHLY WITH WATER. DISCONTINUE USE AND ASK A DOCTOR IF IRRITATION OR RASH DEVELOPS.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

APPLY GENEROUSLY WITH FINGERS TO ENTIRE FACE AND NECK. USE DAILY.

OTHER SAFETY INFORMATION

SUN ALERT: LIMITING SUN EXPOSURE, WEARING PROTECTIVE CLOTHING, AND USING SUNSCREEN MAY REDUCE THE RISK OF SKIN AGING, SKIN CANCER, AND OTHER HARMFUL EFFECTS OF THE SUN.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

WATER, ALOE BARBADENSIS LEAF, GLYCERIN, PROPYLENE GLYCOL, ISOPROPYL PALMITATE, CAPRYLIC/CAPRIC TRIGLYCERIDES, CYCLOPENTASILOXANE, CETEARYL ALCOHOL, CETEARETH-20, VP/EICOSENE COPOLYMER, SQUALANE, POLYSORBATE 60, CYCLOTETRASILOXANE, PHENOXYETHANOL, BUTYROSPERMUM PARKII BUTTER, PERSEA GRATISSIMA (AVOCADO) OIL, TOCOPHERYL ACETATE, VACCINIUM MYRTILLUS FRUIT/LEAF EXTRACT, SACCHARUM OFFICINARIUM (SUGAR CANE) EXTRACT, ACER SACCHARUM EXTRACT, CITRUS AURANTIUM DULCIS FRUIT EXTRACT, CITRUS LIMON (LEMON) FRUIT EXTRACT, CITRUS GRANDIS SEED EXTRACT, HONEY EXTRACT, CITRIC ACID, PHYTONADIONE, METHYLISOTHIAZOLINONE, RED 33.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01b UC_Botanical Soothing Cream SPF 3001b UC_Botanical Soothing Cream SPF 30

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70764-201-522025-12-31C16284748780-12cef2736-858d-d83d-e063-dadaa90ab31fCONTROL CORRECTIVE - BOTANICAL SOOTHING (70764-201)
70764-201-522025-01-30C16284748780-12cef2736-858d-d83d-e063-dadaa90ab31fCONTROL CORRECTIVE - BOTANICAL SOOTHING (70764-201)

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

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 37 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70764-20170764-201-22, 70764-201-52

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 34 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CYCLOMETHICONE 50THT5PCI0RIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
VINYLPYRROLIDONE/EICOSENE COPOLYMER035MV9S1C3IACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)86FQE96TZ4IACT
SQUALANEGW89575KF9IACT
POLYSORBATE 60CAL22UVI4MIACT
CYCLOMETHICONE 4CZ227117JEIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SHEA BUTTERK49155WL9YIACT
AVOCADO OIL6VNO72PFC1IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
VACCINIUM MYRTILLUS WHOLEEE76EZ4QNZIACT
ACER SACCHARUM WHOLEKEG5092LU9IACT
CITRUS AURANTIUM FRUITDQD16J2B5OIACT
CITRUS LIMON WHOLEEEI224A33YIACT
EDETATE DISODIUM7FLD91C86KIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
CAMELLIA OLEIFERA LEAF5077EL0C60IACT
CITRUS MAXIMA SEED083X55C543IACT
HONEYY9H1V576FHIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
PHYTONADIONEA034SE7857IACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
D&C RED NO. 339DBA0SBB0LIACT
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
ZINC OXIDESOI2LOH54ZACTIM

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BOTANICAL SOOTHING SPF-30OCTINOXATE, OCTISALATE, ZINC OXIDECONTROL CORRECTIVE SKINCARE INC00a923fe-e6da-420e-a705-4773ecc2176b2025-12-31WarningsExact identifier
ndc (package): 70764-201-22
ndc (package): 70764-201-52
ndc (product): 70764-201
ndc11 (package): 70764020152
ndc11 (package): 70764020122
spl id: 474bb04f-2be5-2dd9-e063-6394a90a6a3c
spl set id: 00a923fe-e6da-420e-a705-4773ecc2176b