SUNSCREEN- zinc oxide emulsion

Sunscreen by

Drug Labeling and Warnings

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

Zinc Oxide 21%............................................. 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, 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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUNSCREEN 
zinc oxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35192-048
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
ASCORBYL PALMITATE (UNII: QN83US2B0N)
MICA (UNII: V8A1AW0880)
HORSE CHESTNUT (UNII: 3C18L6RJAZ)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
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)
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)
HYDRATED SILICA (UNII: Y6O7T4G8P9)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 35192-048-17	61 g in 1 PACKAGE; Type 0: Not a Combination Product	07/26/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	07/26/2022

Labeler - CA-Botana International (106276728)

Establishment
Name	Address	ID/FEI	Business Operations
CA-Botana International		106276728	manufacture(35192-048)