MINERAL SUNSCREEN- zinc oxide emulsion 
CA-Botana International

----------

DS Mineral Sunscreen SPF 50 Gabriel

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, 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

PACKAGE LABEL PRINCIPAL

Gabriel-Sunscreen-Label.8( 1)

MINERAL SUNSCREEN 
zinc oxide emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35192-044
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE12.81 g  in 12.81 g
Inactive Ingredients
Ingredient NameStrength
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
Colorwhite (white yellowish) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:35192-044-0161 g in 1 TUBE; Type 0: Not a Combination Product08/15/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02008/15/2021
Labeler - CA-Botana International (106276728)
Establishment
NameAddressID/FEIBusiness Operations
CA-Botana International106276728manufacture(35192-044)

Revised: 10/2023
Document Id: 06e5f9d1-98bb-987e-e063-6394a90a88f3
Set id: c7929b18-76f5-af11-e053-2a95a90a183c
Version: 4
Effective Time: 20231004
 
CA-Botana International