Sunscreen (Spf 40) Lotion [Ca-Botana International] -

SUNSCREEN (SPF 40) LOTION [CA-BOTANA INTERNATIONAL]
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NDC	35192-008-02
Set ID	20217be3-4ddb-4d2f-9b77-0afa4c69eeea
Category	HUMAN OTC DRUG LABEL
Packager	CA-BOTANA INTERNATIONAL
Generic Name
Product Class
Product Number
Application Number	PART352

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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. 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

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

ALOE VERA LEAF, ALUMINUM STARCH OCTENYLSUCCINATE, ASCORBIC ACID, ASCORBYL PALMITATE, BORON NITRIDE, CETOSTEARYL ALCOHOL, CETEARYL ISONONANOATE, CITRIC ACID MONOHYDRATE, CAPRYLIC/CAPRIC MONO/DIGLYCERIDES, ETHYLHEXYLGLYCERIN, GLYCERIN, SUNFLOWER OIL, ISOMALT, LECITHIN SOYBEAN, MACADAMIA OIL, NIACIN, PANTHENOL, PHENOXYETHANOL, LECITHIN SOYBEAN, POTASSIUM SORBATE, PROPANEDIOL, ROSA MOSCHATA OIL, ROSEMARY, SODIUM BENZOATE, HYALURONATE SODIUM, TETRASODIUM IMINODISUCCINATE, TOCOPHEROL, GRAPE SEED OIL, WATER
PURPOSE

Sunscreen
ACTIVE INGREDIENT

Titanium Dioxide, Octinoxate
KEEP OUT OF REACH OF CHILDREN

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.
INDICATIONS & USAGE

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
PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

SUNSCREEN
spf 40 lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:35192-008
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	6.8 g in 113.4 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	8.5 g in 113.4 g

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BORON NITRIDE (UNII: 2U4T60A6YD)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL ISONONANOATE (UNII: P5O01U99NI)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CAPRYLIC/CAPRIC MONO/DIGLYCERIDES (UNII: U72Q2I8C85)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
SUNFLOWER OIL (UNII: 3W1JG795YI)
ISOMALT (UNII: S870P55O2W)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
MACADAMIA OIL (UNII: 515610SU8C)
NIACIN (UNII: 2679MF687A)
PANTHENOL (UNII: WV9CM0O67Z)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPANEDIOL (UNII: 5965N8W85T)
ROSA MOSCHATA OIL (UNII: J99W255AWF)
ROSEMARY (UNII: IJ67X351P9)
SODIUM BENZOATE (UNII: OJ245FE5EU)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
TETRASODIUM IMINODISUCCINATE (UNII: GYS41J2635)
TOCOPHEROL (UNII: R0ZB2556P8)
GRAPE SEED OIL (UNII: 930MLC8XGG)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:35192-008-02	113.4 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	06/01/2012

Labeler - CA-BOTANA INTERNATIONAL (106276728)

Registrant - RODOLFO UGELSTAD (106276728)

Name	Address	ID/FEI	Business Operations
Establishment
CA-BOTANA INTERNATIONAL		106276728	manufacture

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Medic

SUNSCREEN (SPF 40) LOTION [CA-BOTANA INTERNATIONAL]

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