Label: HYDROPEPTIDE SOLAR DEFENSE HAND GUARD- titanium dioxide, zinc oxide cream
- NDC Code(s): 60934-011-00
- Packager: HydroPeptide LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 October 18, 2021
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredients
- Uses
- Warnings
- Directions
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Inactive Ingredients
Alumina, Butylene Glycol, Butyrospermum Parkii (Shea) Butter, C12-15 Alkyl Benzoate, Caprylyl Glycol, Caprylyl Methicone, Carbomer, Ceteareth-20, Cetearyl Alcohol, Cetyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Chlorphenesin, Chondrus Crispus (Carrageenan), Cyclohexasiloxane, Cyclopentasiloxane, Glucose, Glycerin, Glyceryl Caprylate, Glyceryl Stearate, Glyceryl Undecylenate, Hydrolyzed Soy Protein, Hydrolyzed Wheat Protein, Isopropyl Myristate, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Lecithin, Niacinamide, PEG-100 Stearate, Phenoxyethanol, Polyhydroxystearic Acid, Pseudoalteromonas Ferment Extract, Sodium PCA, Stearyl Alcohol, Tocopheryl Acetate, Triethanolamine, Triethoxycaprylylsilane, Triethoxysilylethyl Polydimethylsilozyethyl Hexyl Dimethicone, Tripeptide-1, Tripeptide-10 Citrulline, Vitis Vinifera (Grape) Seed Oil, Water (Aqua), Xanthan Gum
- Package Labeling:
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INGREDIENTS AND APPEARANCE
HYDROPEPTIDE SOLAR DEFENSE HAND GUARD
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60934-011 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 12.5 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 25 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALUMINUM OXIDE (UNII: LMI26O6933) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) SHEA BUTTER (UNII: K49155WL9Y) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETYL ALCOHOL (UNII: 936JST6JCN) CHAMOMILE (UNII: FGL3685T2X) CHLORPHENESIN (UNII: I670DAL4SZ) CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78) CYCLOMETHICONE 6 (UNII: XHK3U310BA) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544) HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6) HYDROLYZED WHEAT PROTEIN (ENZYMATIC; 3000 MW) (UNII: J2S07SB0YL) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) NIACINAMIDE (UNII: 25X51I8RD4) PEG-100 STEARATE (UNII: YD01N1999R) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TROLAMINE (UNII: 9O3K93S3TK) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE (UNII: X75PL53TZJ) PREZATIDE (UNII: 39TG2H631E) TRIPEPTIDE-10 CITRULLINE (UNII: 2732R0E76W) GRAPE SEED OIL (UNII: 930MLC8XGG) WATER (UNII: 059QF0KO0R) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60934-011-00 1 in 1 CARTON 01/01/2021 1 75 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/01/2021 Labeler - HydroPeptide LLC (006297465)
