KIDS MINERAL SUNSCREEN STICK SPF 50- zinc oxide stick

Drug Labeling and Warnings

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients:

Zinc Oxide 22.0%

Purpose: Sunscreen

PURPOSE

Uses:

Helps prevent sunburn.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

Stop use and ask a doctor if rash occurs.

WARNINGS

Warning:

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.

DOSAGE & ADMINISTRATION

Directions:

• Apply liberally 15 minutes before sun or water exposure
• ReapplyImmediately after towel drying
• At least every 2 hours
• Children under 6 months: Ask a doctor

INACTIVE INGREDIENT

Caprylic/capric Triglyceride, Ethylhexyl Olivate, Bis-Octyldodecylhexyl Dimer Dilinoleate Propanediol Copolymer, Coco-Caprylate/Caprate, Cocoglycerides, Candelilla (Euphorbia Cerifera) Wax, Ozokerite , Rhus Verniciflua Peel Wax, Jojoba Esters, Butylocyl Salicylate, Butyrospermum Parkii (Shea) Butter, Helianthus Annuus (Sunflower) Seed Wax, Limnanthes Alba (Meadowfoam) Seed Oil, Potassium Olivoyl Hydrolyzed Oat Protein, Squalane, Cetearyl Alcohol, Glyceryl Stearate, Tocopherol, Stearalkonium Hectorite, Olea Europaea (Olive) Oil Unsaponifiables, Stearyl Glycyrrhetinate, Glyceryl Oleate, Water, Propylene Carbonate, Caprylyl Glycol, Bisabolol

PRINCIPAL DISPLAY PANEL

Kids Mineral Sunscreen Stick

0.7 fl oz 20 g

INGREDIENTS AND APPEARANCE

KIDS MINERAL SUNSCREEN STICK SPF 50 
zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83369-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	22 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
TOCOPHEROL (UNII: R0ZB2556P8)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES (UNII: XO45V955LT)
GLYCERYL STEARATE (UNII: 230OU9XXE4)
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)
SHEA BUTTER (UNII: K49155WL9Y)
LEVOMENOL (UNII: 24WE03BX2T)
COCOGLYCERIDES (UNII: ISE9I7DNUG)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
HELIANTHUS ANNUUS (SUNFLOWER) SEED WAX (UNII: 42DG15CHXV)
GLYCERYL OLEATE (UNII: 4PC054V79P)
STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P)
WATER (UNII: 059QF0KO0R)
CERESIN (UNII: Q1LS2UJO3A)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
ETHYLHEXYL OLIVATE (UNII: HTC7G3S2PV)
BIS-OCTYLDODECYL DIMER DILINOLEATE/PROPANEDIOL COPOLYMER (UNII: TY3J98ZR7R)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)
RHUS VERNICIFLUA PEEL WAX (UNII: 6RG2461FCH)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
SQUALANE (UNII: GW89575KF9)
CANDELILLA WAX (UNII: WL0328HX19)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83369-004-01	20 g in 1 CARTON; Type 0: Not a Combination Product	03/02/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	03/02/2026

Labeler - Smalls Brand LLC DBA Roe Wellness (058449263)