Label: CONTROL CORRECTIVE SUNSCREEN SPF-30- octinoxate, octisalate, zinc oxide cream
- NDC Code(s): 70764-204-21, 70764-204-52
- 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
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS
- PURPOSE
-
USE
A MULTI-PURPOSE SUNSCREEN AND FACIAL MOISTURIZER. OFFERS BROAD SPECTRUM UVA & UVB PROTECTION WITHOUT LEAVING A GREASY FILM. HELPS PREVENT AGAINST TANNING AND BURNING. CONTAINS ALOE VERA AND ANTIOXIDANTS TO HELP SOOTHE AND BALANCE THE SKIN. MAY BE USED AS A FACIAL MOISTURIZER TO HELP FIGHT THE SIGNS OF AGING WHICH INCLUDES WRNKLING, DRYNESS, PIGMENTATION AND REDNESS.
- WARNING
- DIRECTIONS
- OTHER SAFETY INFORMATION
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INACTIVE INGREDIENTS
WATER, ALOE BARBADENSIS LEAF, GLYCERIN, PROPYLENE GLYCOL, ISOPROPYL PALMITATE, CAPRYLIC/CAPRIC TRIGLYCERIDES, CYCLOPENTASILOXANE, CETEARYL ALCOHOL, CETEARETH-20, VP/EICOSENE COPOLYMER, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, SQUALANE, POLYSORBATE 60, ACANTHOPANAX SENTICOSUS (ELEUTHERO) ROOT EXTRACT, SYMPHYTUM OFFICINALE LEAF EXTRACT, CITRIC ACID, SODIUM HYALURONATE, CYCLOTETRASILOXANE, PHENOXYETHANOL, TOCOPHERYL ACETATE, TRIETHOXYCAPRYLYLSILANE, METHYLISOTHIAZOLINONE
- KEEP OUT OF REACH OF CHILDREN
- QUESTIONS OR COMMENTS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CONTROL CORRECTIVE SUNSCREEN SPF-30
octinoxate, octisalate, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70764-204 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) ELEUTHERO (UNII: ZQH6VH092Z) COMFREY LEAF (UNII: DG4F8T839X) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) HYALURONATE SODIUM (UNII: YSE9PPT4TH) CYCLOMETHICONE 4 (UNII: CZ227117JE) PHENOXYETHANOL (UNII: HIE492ZZ3T) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) EDETATE DISODIUM (UNII: 7FLD91C86K) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70764-204-52 1 in 1 BOX 09/11/2018 1 NDC:70764-204-21 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 09/11/2018 Labeler - CONTROL CORRECTIVE SKINCARE INC (023999357)