BOTANICAL SOOTHING  SPF-30- octinoxate, octisalate, zinc oxide cream 
CONTROL CORRECTIVE SKINCARE INC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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CONTROL CORRECTIVE - BOTANICAL SOOTHING (70764-201)

ACTIVE INGREDIENTS

OCTINOXATE (6.9%)

OCTISALATE (3.0%)

ZINC OXIDE (4.0%)

PURPOSE

SUNSCREEN

USE

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

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

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

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

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.

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

QUESTIONS OR COMMENTS

WWW.CONTROLCORRECTIVE.COM

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01b UC_Botanical Soothing Cream SPF 30

BOTANICAL SOOTHING   SPF-30
octinoxate, octisalate, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70764-201
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6.9 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE3 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION4 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
SQUALANE (UNII: GW89575KF9)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
CYCLOMETHICONE 4 (UNII: CZ227117JE)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SHEA BUTTER (UNII: K49155WL9Y)  
AVOCADO OIL (UNII: 6VNO72PFC1)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
VACCINIUM MYRTILLUS WHOLE (UNII: EE76EZ4QNZ)  
ACER SACCHARUM WHOLE (UNII: KEG5092LU9)  
CITRUS AURANTIUM FRUIT (UNII: DQD16J2B5O)  
CITRUS LIMON WHOLE (UNII: EEI224A33Y)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
CITRUS MAXIMA SEED (UNII: 083X55C543)  
HONEY (UNII: Y9H1V576FH)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
PHYTONADIONE (UNII: A034SE7857)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70764-201-521 in 1 BOX06/08/2016
1NDC:70764-201-2274 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35206/08/2016
Labeler - CONTROL CORRECTIVE SKINCARE INC (023999357)
Establishment
NameAddressID/FEIBusiness Operations
Chemolee Lab Corporation809982754manufacture(70764-201)

Revised: 9/2023
Document Id: 05f60b1c-0459-b259-e063-6294a90a7420
Set id: 00a923fe-e6da-420e-a705-4773ecc2176b
Version: 5
Effective Time: 20230922
 
CONTROL CORRECTIVE SKINCARE INC