SUNSCREEN - spf 40 lotion 
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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6236 SPF40 Umbrella Sunscreen Lotion

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.

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

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

Sunscreen

Titanium Dioxide, Octinoxate

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.

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

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SUNSCREEN 
spf 40 lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35192-008
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE6.8 g  in 113.4 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE8.5 g  in 113.4 g
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:35192-008-02113.4 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35206/01/2012
Labeler - CA-BOTANA INTERNATIONAL (106276728)
Registrant - RODOLFO UGELSTAD (106276728)
Establishment
NameAddressID/FEIBusiness Operations
CA-BOTANA INTERNATIONAL106276728manufacture

Revised: 6/2012
Document Id: 504333a6-c975-42e9-b6f8-90fcc2788f71
Set id: 20217be3-4ddb-4d2f-9b77-0afa4c69eeea
Version: 1
Effective Time: 20120601
 
CA-BOTANA INTERNATIONAL