SUNSCREEN- zinc oxide emulsion 
CA-Botana International

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Sugared+Bronzed Tinted Sunscreen

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:35192-055
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE19.53 g  in 19.53 g
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
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)  
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)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
MICA (UNII: V8A1AW0880)  
HORSE CHESTNUT (UNII: 3C18L6RJAZ)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
Product Characteristics
Colorbrown (light brownish) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:35192-055-1893 g in 1 PACKAGE; Type 0: Not a Combination Product03/25/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02003/25/2024
Labeler - CA-Botana International (106276728)
Establishment
NameAddressID/FEIBusiness Operations
CA-Botana International106276728manufacture(35192-055)

Revised: 3/2024
Document Id: 1444fc2c-9bd3-b1c6-e063-6294a90a913a
Set id: 1444c150-3c8e-a9f9-e063-6394a90a5d9e
Version: 1
Effective Time: 20240325
 
CA-Botana International