Label: SANTO REMEDIOS PIEL ETERNA RADIANCE SUNSCREEN PRIMER SPF-42- titanium dioxide, zinc oxide lotion
- NDC Code(s): 81352-321-00
- Packager: SANTO REMEDIO LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 6, 2023
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients
- Uses:
- Warnings:
-
Directions:
- Apply liberally 15 minutes before sun exposure and as needed.
- Children under 6 months of age: ask a doctor.
- Reapply:
- after 80 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours
- Sun Protection Measures.
- Limit time in the sun, especially from 10 a.m. - 2 p.m.
- Wear long-sleeved shirts, pants, hats, and sunglasses.
Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
- Other information.
-
Inactive Ingredients:
Bis-Vinyl Dimethicone/ Dimethicone, Copolymer, Camellia Sinensis (Green Tea) Extract, Caprylic/ Capric Triglyceride, Cetyl, PEG/PPG-10/1 Dimethicone, Cocos Nucifera (Coconut) Oil, Cyclopentasiloxane, Cyclotetrasiloxane, Dimethicone, Dimethiconol, Helianthus Annus (Sunflower) Oil, Iron Oxides (Black, Red, White, Yellow), Rubus Idaeus (Rasperry) Extract, Silica, Tetrahexyldecyl Ascorbate (Vitamin C), Tocopheryl Acetate (Vitamin E), Tridecyl Salicylate.
- Questions?
- Package Labeling:
-
INGREDIENTS AND APPEARANCE
SANTO REMEDIOS PIEL ETERNA RADIANCE SUNSCREEN PRIMER SPF-42
titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81352-321 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 60 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 80 mg in 1 mL Inactive Ingredients Ingredient Name Strength GREEN TEA LEAF (UNII: W2ZU1RY8B0) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) COCONUT OIL (UNII: Q9L0O73W7L) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) CYCLOMETHICONE 4 (UNII: CZ227117JE) DIMETHICONE (UNII: 92RU3N3Y1O) HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP) FERRIC OXIDE RED (UNII: 1K09F3G675) RASPBERRY (UNII: 4N14V5R27W) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TRIDECYL SALICYLATE (UNII: AZQ08K38Z1) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81352-321-00 50 mL in 1 TUBE; Type 0: Not a Combination Product 03/21/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 03/21/2022 Labeler - SANTO REMEDIO LLC (117456185)