MINERAL SUNSCREEN- zinc oxide emulsion

Mineral Sunscreen by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredient

Octinoxate 7.5%.............................................Sunscreen

Zinc Oxide 7.0%............................................. Sunscreen

Purpose

Sunscreen

Ask Doctor

Stop use and ask a doctor if rash occurs

Keep out of reach of children

Keep out of reach of children

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

Protect this product from excessive heat and direct sun

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

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. If product is swallowed get medical help or contact a poison Control Center right away.

Indications & Usage

Apply liberally 15 minutes before exposure, use water resistant sunscreen, if swimming or sweating. reapply at least every 2 hours. Children under 6 months: ask a doctor

Mineral Sunscreen SPF 50

INGREDIENTS AND APPEARANCE

MINERAL SUNSCREEN 
zinc oxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35192-042
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	23.814 g  in 113.4 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: 35192-042-02	113.4 g in 1 TUBE; Type 0: Not a Combination Product	04/30/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	04/30/2021

Labeler - CA-Botana International (106276728)

Establishment
Name	Address	ID/FEI	Business Operations
CA-Botana International		106276728	manufacture(35192-042)