BABY DONNA SHEER SPF SUNSCREEN STICK- zinc oxide stick 
BabyDonna LLC

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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Drug Facts

Active Ingredient

Zinc Oxide 19%

Purpose

Sunscreen

Uses

Warnings

Directions

Other Information

Questions?

Contact support@babydonna.com

Inactive Ingredients

Caprylic Capric Triglycerides, Coconut Alkanes (and) Coco-Caprylate/Caprate Polyhydroxystearic Acid, Coco caprylate/caprate, Butyrospermum Parkii (Shea) Butter Copernicia Cerifera (Carnauba) Wax, Arachidyl Alcohol (and) Behenyl Alcohol (and) Arachidyl Glucoside Candelilla Wax (Euphorbia Cerifera), Cetearyl Alcohol 50, Hydrogenated Castor Oil, Glyceryl Caprylate Meadowfoam Seed Oil,Mixed Tocopherols (Vitamin E)

Product label

image descriptionimage description

BABY DONNA SHEER SPF SUNSCREEN STICK 
zinc oxide stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83265-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION19 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
COCONUT ALKANES (UNII: 1E5KJY107T)  
POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE)  
COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
DOCOSANOL (UNII: 9G1OE216XY)  
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
CANDELILLA WAX (UNII: WL0328HX19)  
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)  
TOCOPHEROL (UNII: R0ZB2556P8)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
SHEA BUTTER (UNII: K49155WL9Y)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83265-001-011 in 1 BOX03/01/2023
116 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/01/2023
Labeler - BabyDonna LLC (077317794)

Revised: 2/2023
Document Id: f5c83321-7832-9686-e053-2995a90a538e
Set id: af6b7f9f-9ca5-4c59-be78-d68286451ac3
Version: 1
Effective Time: 20230228
 
BabyDonna LLC