BABY DONNA SHEER SPF SUNSCREEN STICK- zinc oxide stick 
Stream2Sea, 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

      For external use only


Directions

    Sun Protection Measures

   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 value 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-sleeved shirts, pants, hats, and sunglasses.

Other Information

Protect this product from excessive heat and direct sun

Questions?

Contact support@babydonna.com

Inactive Ingredients

Caprylic Capric Triglycerides, Coconut Alkanes (and) Coco-Caprylate/Caprate PolyhydroxystearicAcid, 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

Baby Donna Mineral Sunscreen Sheer 35 SPF- NDC 69555-044-01 -0.5 oz/16 G Stick Label

Baby Donna Mineral Sunscreen Sheer 35 SPF

Baby Donna Mineral Sunscreen Sheer 35 SPF

BABY DONNA SHEER SPF SUNSCREEN STICK 
zinc oxide stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69555-044
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:69555-044-011 in 1 BOX03/28/2023
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 finalpart35203/28/2023
Labeler - Stream2Sea, LLC (052920828)
Establishment
NameAddressID/FEIBusiness Operations
Stream2Sea, LLC052920828manufacture(69555-044)

Revised: 4/2023
Document Id: f87be121-abd0-1c5a-e053-6394a90a0356
Set id: a1b1cdeb-e5fe-4ba1-8bb0-3c7a97dd93fe
Version: 1
Effective Time: 20230404
 
Stream2Sea, LLC