SUNCREEN DAILY DEFENSE LATHER- titanium dioxide,octinoxate emulsion

Suncreen Daily Defense Lather by

Drug Labeling and Warnings

Suncreen Daily Defense Lather by is a Otc medication manufactured, distributed, or labeled by CA-BOTANA INTERNATIONAL, CA-Botana International. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

OTC - Active Ingredient

Titanium Dioxide 5%

Octinoxate 4%

OTC - Purpose

Sunscreen

OTC- Ask Doctor Section

Stop use and ask a doctor if rash occurs

OTC- Keep out of reach 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

Dosage & Adminstration

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. Use a water resistant sunscreen if swimming or sweating. Reapply: at least 2 hours. Children under 6 months: Ask a doctor. Sun protection 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 other sun protection measures including: limit time in the sun, especially from 10 a.m - 2 p.m. Wear long-sleeve shirts, pants, hats, and sunglasses. Protect this product from excessive heat and direct sun

Other Safety information

Protect this product 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 sun 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 display

Package label principal display panel

INGREDIENTS AND APPEARANCE

SUNCREEN DAILY DEFENSE LATHER 
titanium dioxide,octinoxate emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35192-028
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.95 g  in 59 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.36 g  in 59 g

Inactive Ingredients
Ingredient Name	Strength
CETEARYL ISONONANOATE (UNII: P5O01U99NI)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
COCO-CAPRYLATE (UNII: 4828G836N6)
ALMOND OIL (UNII: 66YXD4DKO9)
MICA (UNII: V8A1AW0880)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETYL ALCOHOL (UNII: 936JST6JCN)
PROPANEDIOL (UNII: 5965N8W85T)
ALANINE (UNII: OF5P57N2ZX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARGININE, DL- (UNII: FL26NTK3EP)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)
COCONUT OIL (UNII: Q9L0O73W7L)
GLYCINE (UNII: TE7660XO1C)
SUNFLOWER OIL (UNII: 3W1JG795YI)
NIACIN (UNII: 2679MF687A)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
ROSEMARY (UNII: IJ67X351P9)
PANTHENOL (UNII: WV9CM0O67Z)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROLINE (UNII: 9DLQ4CIU6V)
WATER (UNII: 059QF0KO0R)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
ROSA MOSCHATA OIL (UNII: J99W255AWF)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
EDETATE SODIUM (UNII: MP1J8420LU)
TOCOPHEROL (UNII: R0ZB2556P8)
VITIS VINIFERA SEED (UNII: C34U15ICXA)
XANTHAN GUM (UNII: TTV12P4NEE)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

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: 35192-028-01	59 g in 1 TUBE; Type 0: Not a Combination Product	11/06/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	11/06/2017

Labeler - CA-BOTANA INTERNATIONAL (106276728)

Establishment
Name	Address	ID/FEI	Business Operations
CA-Botana International		106276728	manufacture(35192-028)