SUN DEFENSE CANYON RANCH- titanium dioxide, octinoxate emulsion

Sun Defense Canyon Ranch by

Drug Labeling and Warnings

Sun Defense Canyon Ranch by is a Otc medication manufactured, distributed, or labeled by CA-Botana International. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

SUN DEFENSE CANYON RANCH 
titanium dioxide, octinoxate emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35192-025
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	18.92 g  in 473 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	23.65 g  in 473 g

Inactive Ingredients
Ingredient Name	Strength
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)
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)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 35192-025-09	473 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/15/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	08/15/2016

Labeler - CA-Botana International (106276728)

Establishment
Name	Address	ID/FEI	Business Operations
CA-Botana International		106276728	manufacture(35192-025)