Label: MINERAL SUNSCREEN- zinc oxide emulsion
- NDC Code(s): 35192-044-01
- Packager: CA-Botana International
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 4, 2023
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- Active Ingredient
- Purpose
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- Keep out of reach of children
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Inactive Ingredients
Water (Aqua), Coco-Caprylate/Caprate, Ceteary Alcohol, Propanediol, Stearyl Alcohol, Polyhydroxystearic Acid, Mica, Butyrospermun parki (Shea butter), Cetearyl Olivate, Sorbitan Olivate, Caaprylhydroxamic acid. GlycerylCaprylate, Glycerin, Xanthan Gum, Equisetum arvense (Horsetail) extract, Rosmarinus officinalis (Rosemary) extract, Centella asiatica(Gotu-kola) extract, Aesculus hippocastanum (Horse chestnut) extract, Camellia sinensis(Green tea) extract, Olea europaea (Olive) extract, Tocopheryl Acetate, Potassium Acetate, Sodium Phytate, Citrus nobilis/Mandarinorage) Peel oil, Coconut oil, Helianthus annuus (Sunflower) Seed oil, Silica, Triethpxycapryylsilane, OXY CA (Rosmarinus officnalis (Leaf)CO2 Extract& Ascorbyl Palmitate & Caprylic/Capric Triglyceride & Ascorbic Acid & Tocopherol & Citric Acid )
- Safety information
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Dosage & Administration
Helps prevent sunburn. If used as directed with other sun protection measured decreases the risk of skin cancer and early skin aging caused by the sun. Apply liberally 15 minutes before sun exposure. Usea water resistant sunscreen if swimming or sweating. Reapply : at least 2 hours. Children under 6 months: Ask a doctor. Sun protections measurements. 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 othe sun protection measures including: limit time in the sun, specially from 10 a.m.- 2 p.m Wear long-sleeveshirts, pants, hats, and sunglasses. Protect this product from excessive heat and direct sun.
- Warnings
- Indications & Usage
- PACKAGE LABEL PRINCIPAL
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INGREDIENTS AND APPEARANCE
MINERAL SUNSCREEN
zinc oxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:35192-044 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 12.81 g in 12.81 g Inactive Ingredients Ingredient Name Strength SORBITAN OLIVATE (UNII: MDL271E3GR) EQUISETUM ARVENSE WHOLE (UNII: 73DM367W4P) ASCORBIC ACID (UNII: PQ6CK8PD0R) SUNFLOWER OIL (UNII: 3W1JG795YI) DIMETHICONOL TRIETHOXYCAPRYLYLSILANE TETRAETHYL SILICATE CROSSPOLYMER (4000000 MW) (UNII: 6CA31A9P15) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) CETEARYL OLIVATE (UNII: 58B69Q84JO) ALLANTOIN (UNII: 344S277G0Z) ROSEMARY (UNII: IJ67X351P9) HEXASODIUM PHYTATE (UNII: ZBX50UG81V) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) ETHYL FERULATE (UNII: 5B8915UELW) TOCOPHEROL (UNII: R0ZB2556P8) XANTHAN GUM (UNII: TTV12P4NEE) GLYCERIN (UNII: PDC6A3C0OX) PROPANEDIOL (UNII: 5965N8W85T) WATER (UNII: 059QF0KO0R) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) GLYCERYL CAPRATE (UNII: 197M6VFC1W) CENTELLA ASIATICA (UNII: 7M867G6T1U) GREEN OLIVE (UNII: 6HD2W46UEG) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) ORANGE PEEL (UNII: TI9T76XD44) COCOS NUCIFERA WHOLE (UNII: 245J88W96L) HYDRATED SILICA (UNII: Y6O7T4G8P9) ASCORBYL PALMITATE (UNII: QN83US2B0N) MICA (UNII: V8A1AW0880) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) HORSE CHESTNUT (UNII: 3C18L6RJAZ) GREEN TEA LEAF (UNII: W2ZU1RY8B0) SHEA BUTTER (UNII: K49155WL9Y) Product Characteristics Color white (white yellowish) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:35192-044-01 61 g in 1 TUBE; Type 0: Not a Combination Product 08/15/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 08/15/2021 Labeler - CA-Botana International (106276728) Establishment Name Address ID/FEI Business Operations CA-Botana International 106276728 manufacture(35192-044)
