Label: BOTANICAL SOOTHING SPF-30- octinoxate, octisalate, zinc oxide cream
- NDC Code(s): 70764-201-22, 70764-201-52
- Packager: CONTROL CORRECTIVE SKINCARE INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated September 22, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS
- PURPOSE
- USE
- WARNING
- DIRECTIONS
- OTHER SAFETY INFORMATION
-
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
- QUESTIONS OR COMMENTS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
BOTANICAL SOOTHING SPF-30
octinoxate, octisalate, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70764-201 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 6.9 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 3 g in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 4 g in 100 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:70764-201-52 1 in 1 BOX 06/08/2016 1 NDC:70764-201-22 74 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 06/08/2016 Labeler - CONTROL CORRECTIVE SKINCARE INC (023999357) Establishment Name Address ID/FEI Business Operations Chemolee Lab Corporation 809982754 manufacture(70764-201)
