UMBRELLA- octinoxate titanium dioxide lotion 
CA-BOTANA INTERNATIONAL

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Umbrella Sunscreen

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.

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

labelimage

UMBRELLA 
octinoxate titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35192-007
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.268 g  in 56.7 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.268 g  in 56.7 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)  
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)  
CITRUS AURANTIUM FLOWER OIL (UNII: D4BGE91OXH)  
COCO-CAPRYLATE (UNII: 4828G836N6)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERIN (UNII: PDC6A3C0OX)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
NIACIN (UNII: 2679MF687A)  
PANTHENOL (UNII: WV9CM0O67Z)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
PROPANEDIOL (UNII: 5965N8W85T)  
ROSMARINUS OFFICINALIS FLOWERING TOP OIL (UNII: OXN0D3N28L)  
PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER (UNII: 788QAG3W8A)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
TOCOPHEROL (UNII: R0ZB2556P8)  
GRAPE SEED OIL (UNII: 930MLC8XGG)  
XANTHAN GUM (UNII: TTV12P4NEE)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:35192-007-0156.7 g in 1 TUBE; Type 0: Not a Combination Product08/01/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02008/01/2013
Labeler - CA-BOTANA INTERNATIONAL (106276728)
Registrant - RODOLFO UGELSTAD (106276728)
Establishment
NameAddressID/FEIBusiness Operations
CA-BOTANA INTERNATIONAL106276728manufacture(35192-007)

Revised: 10/2023
Document Id: 078990cb-75b4-9a42-e063-6394a90a1074
Set id: cafca3ab-86ad-4947-b239-a04944eed782
Version: 12
Effective Time: 20231012
 
CA-BOTANA INTERNATIONAL