SUN ESSENTIAL - octinoxate titanium dioxide 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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6234 Sunscreen Sun Essential

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

ALANINE, ALOE VERA LEAF, ARGININE, ASCORBIC ACID, ASCORBYL PALMITATE, .ALPHA.-BISABOLOL, (+/-)-,CAPRYLIC/CAPRIC MONO/DIGLYCERIDES, CETEARYL ISONONANOATE, CETYL ALCOHOL, CITRIC ACID MONOHYDRATE, COCONUT, ETHYLHEXYLGLYCERIN, GLYCERIN, GLYCERYL MONOSTEARATE, GLYCINE, SUNFLOWER OIL, MICA, NIACIN, OLEA EUROPAEA LEAF, PANTHENOL, PHENOXYETHANOL, LECITHIN, SOYBEAN, POTASSIUM SORBATE, SODIUM PYROPHOSPHATE, PENTYLENE GLYCOL, PROPANEDIOL, ALMOND OIL, ROSA MOSCHATA OIL, ROSEMARY, HYALURONATE SODIUM, SODIUM CITRATE, SORBITAN, TOCOPHEROL, UREA, GRAPE SEED OIL, XANTHAN GUM, WATER

Sunscreen

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.

image of label

Titanium Dioxide, Octinoxate

SUN ESSENTIAL 
octinoxate titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35192-009
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.5 g  in 30 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.20 g  in 30 g
Inactive Ingredients
Ingredient NameStrength
ALANINE (UNII: OF5P57N2ZX)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ARGININE (UNII: 94ZLA3W45F)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
.ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)  
CAPRYLIC/CAPRIC MONO/DIGLYCERIDES (UNII: U72Q2I8C85)  
CETEARYL ISONONANOATE (UNII: P5O01U99NI)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
COCONUT (UNII: 3RT3536DHY)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
GLYCINE (UNII: TE7660XO1C)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
MICA (UNII: V8A1AW0880)  
NIACIN (UNII: 2679MF687A)  
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)  
PANTHENOL (UNII: WV9CM0O67Z)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
PROPANEDIOL (UNII: 5965N8W85T)  
ALMOND OIL (UNII: 66YXD4DKO9)  
ROSA MOSCHATA OIL (UNII: J99W255AWF)  
ROSEMARY (UNII: IJ67X351P9)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SORBITAN (UNII: 6O92ICV9RU)  
TOCOPHEROL (UNII: R0ZB2556P8)  
UREA (UNII: 8W8T17847W)  
GRAPE SEED OIL (UNII: 930MLC8XGG)  
XANTHAN GUM (UNII: TTV12P4NEE)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:35192-009-0530 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: 9c7c3ae2-0f21-4e58-810f-8a661936f405
Set id: eba71a0a-cefc-47d3-87ea-74ffea8dea6c
Version: 3
Effective Time: 20120601
 
CA-BOTANA INTERNATIONAL