BION 8 FLOZ PURE MINERAL SUNSCREEN SPF 30- sunscreen emulsion

Bion 8 FLOz Pure Mineral Sunscreen SPF 30 by

Drug Labeling and Warnings

Bion 8 FLOz Pure Mineral Sunscreen SPF 30 by is a Otc medication manufactured, distributed, or labeled by CA-Botana International INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Warnings

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 a 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. Reapply: at least 2 hours. Children under 6 months: Ask a doctor. Sun protection 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 other sun protection measures including: limit time in the sun, especially from 10 a.m - 2 p.m. Wear long-sleeve shirts, pants, hats, and sunglasses. Protect this product from excessive heat and direct sun

Inactive Ingredients

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.

Active ingredients

Zinc Oxide 19% Sunscreen

Warning

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 a poison control center right away.

EDIT

Keep out out reach of Children

Keep out of reach of children section [OTC - KEEP OUT OF REACH OF CHILDREN SECTION] For external use only.

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

symptoms persist for more than seven days, discontinue

use of the product.

Indications of usage

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. Reapply: at least 2 hours. Children under 6 months: Ask a doctor. Sun protection 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 other sun protection measures including: limit time in the sun, especially from 10 a.m - 2 p.m. Wear long-sleeve shirts, pants, hats, and sunglasses. Protect this product from excessive heat and direct sun

Purpose

Sunscreen

Package Label

INGREDIENTS AND APPEARANCE

BION 8 FLOZ PURE MINERAL SUNSCREEN SPF 30 
sunscreen emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35192-061
Route of Administration	TOPICAL

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

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

Product Characteristics
Color	white (Yellowish)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 35192-061-15	240 g in 1 BOTTLE; Type 0: Not a Combination Product	05/08/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/08/2025

Labeler - CA-Botana International INC (106276728)

Establishment
Name	Address	ID/FEI	Business Operations
CA-Botana International INC		106276728	manufacture(35192-061)