Label: HYDRATINT PRO MINERAL BROAD SPECTRUM SUNSCREEN SPF- titanium dioxide and zinc oxide cream
- NDC Code(s): 70604-011-00, 70604-011-02, 70604-011-04, 70604-011-99
- Packager: Alastin Skincare, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 4, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
- Warnings
-
Directions
- Apply liberally 15 minutes before sun exposure
- Reapply:
- After 40 minutes of swimming or sweating
- Immediately after towel drying
- At least every 2 hours
- Children under 6 months of age: Ask a doctor.
Sun Protection measures. 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 of 15 or higher and other sun protection measures including:
- Limit time in the sun, especially from 10am - 2pm
- Wear long-sleeved shirts, pants, hats and sunglasses
-
Inactive Ingredients
Water/Aqua/Eau, Cyclopentasiloxane, Dimethicone, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Butylene Glycol, Aluminum Hydroxide, Stearic Acid, Thermus Thermophillus Ferment, PEG-9 Polydimethylsiloxyethyl Dimethicone, Sodium Chloride, Camellia Sinensis Leaf Extract, Hydroxymethoxyphenyl Decanone, Dunaliella Salina Extract, Asteriscus Graveolens Flower/Fruit/Leaf/Stem Extract, Ergothioneine, Ectoin, Squalane, Glycerin, Caprylic/Capric Triglyceride, Tocopherol, Tocopheryl Acetate, Dimethicone/PEG-10/15 Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Ethylhexylglycerin, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, PEG/PPG-18/18 Dimethicone, Triethoxycaprylylsilane, Sodium Citrate, Potassium Sorbate, Dipropylene Glycol, Phenoxyethanol, Iron Oxides (CI 77492), Iron Oxides (CI 77491), Iron Oxides (CI 77499)
- Other Information
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 91 g Tube Carton
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INGREDIENTS AND APPEARANCE
HYDRATINT PRO MINERAL BROAD SPECTRUM SUNSCREEN SPF
titanium dioxide and zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70604-011 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.089 g in 1 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 0.034 g in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DIMETHICONE (UNII: 92RU3N3Y1O) POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) THERMUS THERMOPHILUS LYSATE (UNII: 775R692494) PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F) SODIUM CHLORIDE (UNII: 451W47IQ8X) GREEN TEA LEAF (UNII: W2ZU1RY8B0) 1-(4-HYDROXY-3-METHOXYPHENYL)-DECAN-3-ONE (UNII: BO24ID7E9U) DUNALIELLA SALINA (UNII: F4O1DKI9A6) ERGOTHIONEINE (UNII: BDZ3DQM98W) ECTOINE (UNII: 7GXZ3858RY) SQUALANE (UNII: GW89575KF9) GLYCERIN (UNII: PDC6A3C0OX) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) TOCOPHEROL (UNII: R0ZB2556P8) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE (UNII: X75PL53TZJ) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) DIPROPYLENE GLYCOL (UNII: E107L85C40) PHENOXYETHANOL (UNII: HIE492ZZ3T) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) Product Characteristics Color BROWN Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70604-011-99 12 in 1 CARTON 03/01/2022 1 6 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:70604-011-00 12 g in 1 TUBE; Type 0: Not a Combination Product 03/01/2022 3 NDC:70604-011-02 1 in 1 CARTON 03/01/2022 3 91 g in 1 TUBE; Type 0: Not a Combination Product 4 NDC:70604-011-04 130 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 03/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph drug M020 09/24/2021 Labeler - Alastin Skincare, Inc. (085997348) Registrant - Wasatch Product Development, LLC (962452533)
