SUN DEFENSE CANYON RANCH- titanium dioxide, octinoxate emulsion 
CA-Botana International

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Sunscreen Sun Defense Lotion CanyonRanch

Active Ingredient

Titanium Dioxide 5%...................................Sunscreen

Octinoxate 4%.............................................Sunscreen

Purpose

Sunscreen

Ask Doctor

Stop use and ask a doctor if rash occurs

Keep out of rech of children

Keep out of reach of children

Inactive Ingredients

Water (Aqua), Glycerine, Glyceryl stearate SE, Cetearyl isononanoate, Coco caprylate, Prunus amygdalus dulcis (Sweet Almond) oil, Mica, Caprylic/Capric triglyceride, Cetyl alcohol, Propanediol, Alanine, Aloe barbadensis leaf extract, Arginine, Ascorbic acid, Ascorbyl palmitate, Bisabolol, Cocos nucifera (Coconut) oil, Glycine, Helianthus annuus (Sunflower) seed oil, Niacin, Olea europaea (Olive) leaf , Panthenol, Phospholipids, Potassium sorbate, Proline, Pentylene glycol, Prunus amygdalus dulcis (Sweet Almond) oil, Rosa canina (Rosehip) oil, Rosmarinus officinalis leaf (Rosemary), Sodium hyaluronate, Sodium citrate, Sorbitan monostearate, Tetrasodium EDTA, Tocopherol, Urea,Vitis vinifera (Grape) seed, Xanthan gum, Citric acid, Ethylhexylglycerin, Phenoxyethanol

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


1 jpg

SUN DEFENSE CANYON RANCH 
titanium dioxide, octinoxate emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35192-025
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE23.65 g  in 473 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE18.92 g  in 473 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)  
GLYCINE (UNII: TE7660XO1C)  
ALMOND OIL (UNII: 66YXD4DKO9)  
MICA (UNII: V8A1AW0880)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
COCONUT OIL (UNII: Q9L0O73W7L)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
TOCOPHEROL (UNII: R0ZB2556P8)  
XANTHAN GUM (UNII: TTV12P4NEE)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)  
ROSEMARY (UNII: IJ67X351P9)  
PANTHENOL (UNII: WV9CM0O67Z)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
PROLINE (UNII: 9DLQ4CIU6V)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
CETEARYL ISONONANOATE (UNII: P5O01U99NI)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
COCO-CAPRYLATE (UNII: 4828G836N6)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
ALANINE (UNII: OF5P57N2ZX)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
PROPANEDIOL (UNII: 5965N8W85T)  
ARGININE, DL- (UNII: FL26NTK3EP)  
NIACIN (UNII: 2679MF687A)  
ROSA MOSCHATA OIL (UNII: J99W255AWF)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
EDETATE SODIUM (UNII: MP1J8420LU)  
VITIS VINIFERA SEED (UNII: C34U15ICXA)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
CAPRYLIC/CAPRIC MONO/DIGLYCERIDES (UNII: U72Q2I8C85)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
Product Characteristics
Colorwhite (white yellowish) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:35192-025-09473 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/15/201612/02/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/15/201612/02/2022
Labeler - CA-Botana International (106276728)
Establishment
NameAddressID/FEIBusiness Operations
CA-Botana International106276728manufacture(35192-025)

Revised: 12/2022
 
CA-Botana International