Label: SUNSCREEN- zinc oxide emulsion
- NDC Code(s): 35192-050-17
- Packager: CA-Botana International
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 8, 2023
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- Active Ingredient
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Inactive Ingredients
Water (Aqua), Coco-Caprylate/Caprate, Ceteary Alcohol, Propanediol, Stearyl Alcohol, Polyhydroxystearic Acid, Mica, Cetearyl Olivate, Sorbitan Olivate, Caprylhydroxamic 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 Sorbate, Sodium Phytate, Carthamus tinctorius (Safflower ) Seed oil, Silica, Triethoxycapryylsilane, OXY CA (Rosmarinus officnalis (Leaf)CO2 Extract& Ascorbyl Palmitate & Caprylic/Capric Triglyceride & Ascorbic Acid & Tocopherol & Citric Acid ), Glyceryl Stearate, Iron Oxide.
- 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.
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INGREDIENTS AND APPEARANCE
SUNSCREEN
zinc oxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:35192-050 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 ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) PEG-8 CAPRYLIC/CAPRIC GLYCERIDES (UNII: 00BT03FSO2) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) SAFFLOWER OIL (UNII: 65UEH262IS) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) SORBITAN OLIVATE (UNII: MDL271E3GR) EQUISETUM ARVENSE WHOLE (UNII: 73DM367W4P) ASCORBIC ACID (UNII: PQ6CK8PD0R) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) CETEARYL OLIVATE (UNII: 58B69Q84JO) ROSEMARY (UNII: IJ67X351P9) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) TOCOPHEROL (UNII: R0ZB2556P8) XANTHAN GUM (UNII: TTV12P4NEE) GLYCERIN (UNII: PDC6A3C0OX) PROPANEDIOL (UNII: 5965N8W85T) WATER (UNII: 059QF0KO0R) BROWN IRON OXIDE (UNII: 1N032N7MFO) HEXASODIUM PHYTATE (UNII: ZBX50UG81V) 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) HYDRATED SILICA (UNII: Y6O7T4G8P9) ASCORBYL PALMITATE (UNII: QN83US2B0N) MICA (UNII: V8A1AW0880) HORSE CHESTNUT (UNII: 3C18L6RJAZ) GREEN TEA LEAF (UNII: W2ZU1RY8B0) Product Characteristics Color brown (light brownish) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:35192-050-17 61 g in 1 PACKAGE; Type 0: Not a Combination Product 07/31/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 07/31/2022 Labeler - CA-Botana International (106276728) Establishment Name Address ID/FEI Business Operations CA-Botana International 106276728 manufacture(35192-050)
