BABO BOTANICALS DAILY SHEER MINERAL SUNSCREEN SPF 40- zinc oxide, titanium dioxide lotion 
Babo Botanicals, Inc.

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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Babo Botanicals Daily Sheer Mineral Sunscreen SPF 40

Active Ingredients

Titanium Dioxide 5.9%

Zinc Oxide 3.3%

Purpose

Sunscreen

Uses

• Helps prevent sunburn.

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 doctor

  • if rash occurs.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Sun Protection Measures Sun exposure increases risk of skin cancer and early skin aging. To decrease risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10a.m. - 2p.m. Wear long sleeved shirts, pants, hats and sunglasses.

Inactive ingredients

Aloe Barbadensis Leaf Juice*, Aluminum Hydroxide, Beeswax*, Butyrospermum Parkii (Shea Butter)*, Camellia Sinensis (Green Tea) Leaf Extract, Cetearyl Alcohol, Coco-Glucoside, Dehydroxanthan Gum, Dicaprylyl Carbonate, Ethylhexylglycerin, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Hydrogen Dimethicone, Hydrolyzed Wheat Protein/PVP Crosspolymer, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Methyl Dihydroabietate, Myristyl Alcohol, Myristyl Glucoside, Persea Gratissima (Avocado) Oil, Phenethyl Alcohol, Pongamia Pinnata Seed Oil, Ricinus Communis (Castor) Seed Oil, Rosa Canina Fruit Extract, Simmondsia Chinensis (Jojoba) Seed Oil*, Triethoxycaprylylsilane, Water (Aqua).

*Certified Organic Ingredients

Package Label

1

BABO BOTANICALS DAILY SHEER MINERAL SUNSCREEN SPF 40 
zinc oxide, titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79265-8708
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE33 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE59 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
JOJOBA OIL (UNII: 724GKU717M)  
CASTOR OIL (UNII: D5340Y2I9G)  
ROSA CANINA FRUIT (UNII: 3TNW8D08V3)  
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
DEHYDROXANTHAN GUM (UNII: 63ZP7I1BQO)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)  
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
AVOCADO OIL (UNII: 6VNO72PFC1)  
WATER (UNII: 059QF0KO0R)  
SHEA BUTTER (UNII: K49155WL9Y)  
MYRISTYL GLUCOSIDE (UNII: 6AK28695LF)  
KARUM SEED OIL (UNII: 62160PU6FJ)  
COCO GLUCOSIDE (UNII: ICS790225B)  
MYRISTYL ALCOHOL (UNII: V42034O9PU)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GLYCERIN (UNII: PDC6A3C0OX)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79265-8708-11 in 1 BOX03/01/2023
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02003/01/2023
Labeler - Babo Botanicals, Inc. (058258734)

Revised: 11/2022
Document Id: ee004474-bec9-52c7-e053-2995a90ae89a
Set id: ee005198-56e2-1739-e053-2a95a90a7659
Version: 1
Effective Time: 20221121
 
Babo Botanicals, Inc.