SUN DEFENSE CREAM- octinoxate titanium dioxide lotion

Sun Defense Cream by

Drug Labeling and Warnings

Sun Defense Cream by is a Otc medication manufactured, distributed, or labeled by CA-BOTANA INTERNATIONAL, RODOLFO UGELSTAD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Warning and Precautions Section

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. Stop use and ask a doctor if rash occurs. Keep out of reach of children. If product is swallowed, get medical help or contact a poison control center right away.

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

ALOE VERA LEAF

ALUMINUM STARCH OCTENYLSUCCINATE

ASCORBIC ACID

ASCORBYL PALMITATE

BORON NITRIDE

CAMELLIA SINENSIS FLOWER

CAPRYLIC/CAPRIC MONO/DIGLYCERIDES

STEARYL ALCOHOL

CETYL ALCOHOL

CETEARYL ESONONANOATE

CITRIC ACID MONOHYDRATE

CITRUS AURANTIUM FLOWER OIL

COCO-CAPRYLATE

ETHYLHEXYLGLYCERIN

GLYCERIN

SUNFLOWER OIL

NEACEN

PANTHENOL

PHENOXYETHANOL

EGG PHOSPHOLIPIDS

POTASSIUM SORBATE

PROPANEDIOL

ROSMARINUS OFFICINALIS FLOWERING TOP OIL

PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER

SORBITAN STEARATE

TOCOPHEROL

GRAPE SEED OIL

XANTHAN GUM

WATER

OTC - ACTIVE INGREDIENT SECTION

OCTINOXATE

TITANIUM DIOXIDE

OTC - PURPOSE SECTION

keep out of reach of children section

For external use only.

Avoid contact with eyes.

Keep out of reach of children.

Do not apply to open wounds.

STOP USE AND ask a doctor if condition worsens or

symptoms persist for more than seven days, discontinue

use of the product.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUN DEFENSE CREAM 
octinoxate titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35192-022
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.372 g  in 0.375 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.372 g  in 0.375 g

Inactive Ingredients
Ingredient Name	Strength
HYALURONIC ACID (UNII: S270N0TRQY)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BORON NITRIDE (UNII: 2U4T60A6YD)
CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17)
CAPRYLIC/CAPRIC MONO/DIGLYCERIDES (UNII: U72Q2I8C85)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
CETYL ALCOHOL (UNII: 936JST6JCN)
CETEARYL ISONONANOATE (UNII: P5O01U99NI)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
COCO-CAPRYLATE (UNII: 4828G836N6)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
NIACIN (UNII: 2679MF687A)
PANTHENOL (UNII: WV9CM0O67Z)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPANEDIOL (UNII: 5965N8W85T)
ROSMARINUS OFFICINALIS FLOWERING TOP OIL (UNII: OXN0D3N28L)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
TOCOPHEROL (UNII: R0ZB2556P8)
GRAPE SEED OIL (UNII: 930MLC8XGG)
XANTHAN GUM (UNII: TTV12P4NEE)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 35192-022-09	9.3 g in 1 TUBE; Type 0: Not a Combination Product	09/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	09/01/2015

Labeler - CA-BOTANA INTERNATIONAL (106276728)

Registrant - RODOLFO UGELSTAD (106276728)

Establishment
Name	Address	ID/FEI	Business Operations
CA-BOTANA INTERNATIONAL		106276728	manufacture(35192-022)