BABY DONNA SHEER SPF SUNSCREEN STICK- zinc oxide stick

Baby Donna SHeer SPF Sunscreen Stick by

Drug Labeling and Warnings

Baby Donna SHeer SPF Sunscreen Stick by is a Otc medication manufactured, distributed, or labeled by Stream2Sea, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Zinc Oxide 19%

Purpose

Sunscreen

Uses

• Helps prevent sunburn. 
• If used as directed with other other sun protection measures (see  Directions) , decreases the risk of skin cancer and early skin aging caused by the sun.

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

Directions

• Apply liberally 15min before sun exposure. Reapply after 80mins of swimming or sweating immediately after towel drying and at least every 2 hrs. For children under 6 months of age; ask a doctor.

    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.

KEEP OUT OF REACH OF CHILDREN

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

INGREDIENTS AND APPEARANCE

BABY DONNA SHEER SPF SUNSCREEN STICK 
zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69555-044
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	19 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69555-044-01	1 in 1 BOX	03/28/2023
1		16 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/28/2023

Labeler - Stream2Sea, LLC (052920828)

Establishment
Name	Address	ID/FEI	Business Operations
Stream2Sea, LLC		052920828	manufacture(69555-044)