BION PURE MINERAL SUNSCREEN- sunscreen lotion

Bion Pure Mineral Sunscreen by

Drug Labeling and Warnings

Bion Pure Mineral Sunscreen by is a Otc medication manufactured, distributed, or labeled by CA Botana International INC, CA Botana International INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Warning and Precautions

For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove . Stop use and ask a doctor if rash occurs. Keep out of reach of children. If product is swallowed, get medical help or contact poison control center right away

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. Use a water resistant sunscreen if swimming or sweating. Reaply at least every 2 hours. Children under 6 months: Ask a doctor. Sun protection measurments: Spending in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with broad spectrumSPF 15 or higher and other sun protection measures including: limit time in the sun, specially from 10:00 am to 2:00 pm Wear long sleeve shirts, pants, hats, and sun glasses. Protect this product from excessive heat and direct sun

Keep out of reach of children

Avoid contact with eyes,Keep out of reach of children, Do not apply to open wounds Stop use and ask a doctor if condition worsens or symptons persist for more than seven days, discontinue use of the product

Purpose section

Sunscreen, helps prevent sunburn

Active Ingredient

Zinc Oxide 19%

Warning

Keep out of reach of children. If product is swallowed, get medical help or contact poison control center right away

Indication of usage

Keep out of reach of children. If product is swallowed, get medical help or contact poison control center right away

Inactive Inggredients

Hyaluronic Acid, Cetearyl Alcohol,Glycerin, Horse Chestnut, Vanilla Planifolia Fruit, Xanthan Gum, Hydrated Silica, Alkyl (C12-15) Benzoate, Phenoxyethanol, Triethoxycaprylylsilane, Potassium Sorbate, Beeswax, Ascorbyl Palmitate, Stearic Acid, Ceteareth-15, Macadamia Ternifolia Seed oil, Mica, Isomalt, Green tea leaf. Polyhidroxystearic acid stearate, Olea Europaea (Olive) leaf powder, Vitis Vinifera (Grape) seed oil, Ascorbic Acid, Propanediol, .Alpha.-Tocopherol Acetate, D, Ethylhexylglycerin, Lecithin, Soybean, Caprylic/Capric Triglyceride,Tocopherol, Aloe, Decyl Oleate, Ethylhexyl Palmitate, Water, Shea Butter, Rosmarinus Officinalis (Rosemary) Leaf powder, Panthenol, Phosphatidylcholine, Soybean, Citric Acid, Orange oil, Niacinamide, Stearyl Alcohol, Centella Asiatica, Coco-Caprilate/Caprate, Phytate Sodium.

Package Label

INGREDIENTS AND APPEARANCE

BION PURE MINERAL SUNSCREEN 
sunscreen lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35192-058
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	19 g  in 19 g

Inactive Ingredients
Ingredient Name	Strength
HYALURONIC ACID (UNII: S270N0TRQY)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
PHYTATE SODIUM (UNII: 88496G1ERL)
GLYCERIN (UNII: PDC6A3C0OX)
HORSE CHESTNUT (UNII: 3C18L6RJAZ)
VANILLA PLANIFOLIA FRUIT (UNII: Q74T35078H)
XANTHAN GUM (UNII: TTV12P4NEE)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
EQUISETUM ARVENSE LEAF POWDER (UNII: 1L0VKZ185E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
BEESWAX (UNII: 2ZA36H0S2V)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
STEARIC ACID (UNII: 4ELV7Z65AP)
CETEARETH-15 (UNII: 867H4YOZ8Z)
MACADAMIA TERNIFOLIA SEED OIL (UNII: 515610SU8C)
MICA (UNII: V8A1AW0880)
ISOMALT (UNII: S870P55O2W)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE)
OLEA EUROPAEA (OLIVE) LEAF POWDER (UNII: MJ95C3OH47)
VITIS VINIFERA (GRAPE) SEED OIL (UNII: 930MLC8XGG)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
PROPANEDIOL (UNII: 5965N8W85T)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
TOCOPHEROL (UNII: R0ZB2556P8)
ALOE (UNII: V5VD430YW9)
DECYL OLEATE (UNII: ZGR06DO97T)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
WATER (UNII: 059QF0KO0R)
SHEA BUTTER (UNII: K49155WL9Y)
ROSMARINUS OFFICINALIS (ROSEMARY) LEAF POWDER (UNII: IJ67X351P9)
PANTHENOL (UNII: WV9CM0O67Z)
PHOSPHATIDYLCHOLINE, SOYBEAN (UNII: 1T6N4D9YV6)
CITRIC ACID (UNII: 2968PHW8QP)
ORANGE OIL (UNII: AKN3KSD11B)
NIACINAMIDE (UNII: 25X51I8RD4)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
CENTELLA ASIATICA (UNII: 7M867G6T1U)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 35192-058-14	50 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/17/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	04/17/2025

Labeler - CA Botana International INC (106276728)

Establishment
Name	Address	ID/FEI	Business Operations
CA Botana International INC		106276728	manufacture(35192-058)