OTC Medication Information: Sunscreen

SUNSCREEN- zinc oxide emulsion
CA-Botana International

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

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SUNSCREEN
zinc oxide emulsion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:35192-055
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 19.53 g in 19.53 g
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID
PEG-8 CAPRYLIC/CAPRIC GLYCERIDES
TRIETHOXYCAPRYLYLSILANE
SAFFLOWER OIL
GLYCERYL STEARATE SE
SORBITAN OLIVATE
EQUISETUM ARVENSE WHOLE
ASCORBIC ACID
STEARYL ALCOHOL
POLYHYDROXYSTEARIC ACID (2300 MW)
CETEARYL OLIVATE
ROSEMARY
POTASSIUM SORBATE
TOCOPHEROL
XANTHAN GUM
GLYCERIN
PROPANEDIOL
WATER
BROWN IRON OXIDE
HEXASODIUM PHYTATE
COCO-CAPRYLATE/CAPRATE
CAPRYLHYDROXAMIC ACID
GLYCERYL CAPRATE
CENTELLA ASIATICA
GREEN OLIVE
.ALPHA.-TOCOPHEROL ACETATE, DL-
HYDRATED SILICA
ASCORBYL PALMITATE
MICA
HORSE CHESTNUT
GREEN TEA LEAF
Product Characteristics
Color brown (light brownish) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:35192-055-18 93 g in 1 PACKAGE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M020 03/25/2024
Labeler — CA-Botana International (106276728)
Establishment
Name Address ID/FEI Operations
CA-Botana International 106276728 manufacture (35192-055)

Revised: 03/2024 CA-Botana International

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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