Label: HYDROPEPTIDE S.P.F. SUN PROTECTION FRIENDS- titanium dioxide, zinc oxide kit
- NDC Code(s): 60934-010-00, 60934-011-00, 60934-012-00
- Packager: HydroPeptide LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 14, 2023
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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
- Drug Facts
- Active Ingredients
- Uses
- Warnings
-
Directions
• Apply liberally and evenly 15 minutes before sun exposure. • Reapply at least every 2 hours. • Use a water-resistant sunscreen if swimming or sweating. • Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: • Limit time in the sun, especially from 10 a.m. - 2 p.m. • Wear long-sleeved shirts, pants, hats, and sunglasses. • Children under 6 months of age: Ask a doctor
Sun Protection Measures. -
Inactive Ingredients
1,2-Hexanediol, Acrylates/Ammonium Methacrylate Copolymer, Allantoin, Aloe Barbadensis Leaf Juice, Alpinia Galanga Extract, Alumina, Benzyl Benzoate, Benzyl Salicylate, Biotin, Boron Nitride, Butylene Glycol, C12-15 Alkyl Benzoate, Calendula Officinalis Flower Extract, Camellia Oleifera Leaf Extract, Caprylyl Glycol, Caprylyl Methicone, Cellulose Acetate, Cetyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Chlorphenesin, Citral, Citric Acid, Cucumis Sativus (Cucumber) Fruit Extract, Cyclomethicone, Cyclopentasiloxane, Dimethicone, Disodium EDTA, Ethylhexyl Palmitate, Euterpe Oleracea Fruit Extract, Fragrance (Parfum), Glycerin, Glyceryl Stearate, Hexyl Cinnamal, Hydrolyzed Yeast Protein, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Iron Oxide (CI 77491), Iron Oxide (CI 77492), Iron Oxide (CI 77499), Lauryl Peg-9 Polydimethylsiloxyethyl Dimethiconez, Limonene, Linalool, Magnesium Stearate, Methyl Ionone, Niacinamide, Panthenol, PEG-100 Stearate, Pentylene Glycol, Polyhydroxystearic Acid, Polysorbate 60, Propanediol, Propylene Glycol Stearate, Propylene Glycol, Pyridoxine HCl, Sodium Citrate, Sodium Hyaluronate, Sodium PCA, Thermus Thermophilus Ferment, Triethoxycaprylylsilane, Triethoxysilylethyl Polydimethylsiloxyethyl Dimethicone, Water (Aqua), Xanthan Gum, Stearyl Alcohol, Tocopheryl Acetate, Triethanolamine, Triethoxycaprylylsilane, Triethoxysilylethyl Polydimethylsilozyethyl Hexyl Dimethicone, Tripeptide-1, Tripeptide-10 Citrulline, Vitis Vinifera (Grape) Seed Oil, Water (Aqua), Xanthan Gum
- Other Information
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INGREDIENTS AND APPEARANCE
HYDROPEPTIDE S.P.F. SUN PROTECTION FRIENDS
titanium dioxide, zinc oxide kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60934-010 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60934-010-00 1 in 1 KIT 01/01/2021 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 TUBE 75 mL Part 2 1 TUBE 15 mL Part 1 of 2 HYDROPEPTIDE SOLAR DEFENSE HAND GUARD
titanium dioxide, zinc oxide creamProduct Information 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 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 Drug M020 01/01/2021 Part 2 of 2 HYDROPEPTIDE SOLAR DEFENSE TINTED
titanium dioxide, zinc oxide creamProduct Information Item Code (Source) NDC:60934-012 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 25 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 60 mg in 1 mL Inactive Ingredients Ingredient Name Strength 1,2-HEXANEDIOL (UNII: TR046Y3K1G) ALLANTOIN (UNII: 344S277G0Z) ALOE VERA LEAF (UNII: ZY81Z83H0X) ALUMINUM OXIDE (UNII: LMI26O6933) BENZYL BENZOATE (UNII: N863NB338G) BENZYL SALICYLATE (UNII: WAO5MNK9TU) BIOTIN (UNII: 6SO6U10H04) BORON NITRIDE (UNII: 2U4T60A6YD) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) CELLULOSE ACETATE (UNII: 3J2P07GVB6) CETYL ALCOHOL (UNII: 936JST6JCN) CHAMOMILE (UNII: FGL3685T2X) CHLORPHENESIN (UNII: I670DAL4SZ) CITRAL (UNII: T7EU0O9VPP) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) CUCUMBER (UNII: YY7C30VXJT) CYCLOMETHICONE (UNII: NMQ347994Z) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DIMETHICONE (UNII: 92RU3N3Y1O) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) ETHYLHEXYL PALMITATE (UNII: 2865993309) ACAI (UNII: 46AM2VJ0AW) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) LIMONENE, (+)- (UNII: GFD7C86Q1W) LINALOOL, (+/-)- (UNII: D81QY6I88E) MAGNESIUM STEARATE (UNII: 70097M6I30) METHYL IONONES (UNII: EL78BGX1LO) NIACINAMIDE (UNII: 25X51I8RD4) PANTHENOL (UNII: WV9CM0O67Z) PEG-100 STEARATE (UNII: YD01N1999R) PENTYLENE GLYCOL (UNII: 50C1307PZG) POLYSORBATE 60 (UNII: CAL22UVI4M) PROPANEDIOL (UNII: 5965N8W85T) PROPYLENE GLYCOL MONOSTEARATE (UNII: MZM1I680W0) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) SODIUM CITRATE (UNII: 1Q73Q2JULR) HYALURONATE SODIUM (UNII: YSE9PPT4TH) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) THERMUS THERMOPHILUS LYSATE (UNII: 775R692494) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) WATER (UNII: 059QF0KO0R) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TROLAMINE (UNII: 9O3K93S3TK) PREZATIDE (UNII: 39TG2H631E) TRIPEPTIDE-10 CITRULLINE (UNII: 2732R0E76W) GRAPE SEED OIL (UNII: 930MLC8XGG) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60934-012-00 1 in 1 CARTON 1 15 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 Drug M020 01/01/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 01/01/2021 Labeler - HydroPeptide LLC (006297465)
