KIDS FACE AND BODY SUNSCREEN SPF 50- zinc oxide stick

Kids Face and Body Sunscreen SPF 50 by

Drug Labeling and Warnings

Kids Face and Body Sunscreen SPF 50 by is a Otc medication manufactured, distributed, or labeled by Hello Bello. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Zinc Oxide 21.0%

Purpose

Sunscreen

Uses

• Helps prevent sunburn
• If used as directed with 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

broken or damaged skin

When using this product

Keep out of eyes. Rinse with water to remove

Stop use and ask a doctor if

rash occurs

Keep out of reach of children.

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

Directions

Apply liberally and spread evenly by hand 15 minutes before sun exposure
Reapply:
after 80 minutes of swimming or sweating
immediately after towel use
at least every 2 hours
For children under 6 months of age, ask a doctor
Sun Protection Measures: Spending time in the sun can increase your risk of skin cancer and early skin aging. To decrease this risk, regularly use 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

Other Information

• Protect the product in this container from excessive heat and direct sun
• Avoid long-term exposure storage above 40°C (104°F)
• May stain some fabrics

Inactive Ingredients

Bisabolol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter*, Cocos Nucifera (Coconut) Oil*, Copernicia Cerifera (Carnauba) Wax, Euphorbia Cerifera (Candelila) Wax, Helianthus Annuus (Sunflower) Seed Oil, Olea Europaea (Olive) Fruit Oil, Oryzanol, Theobroma Cacao (Cocoa) Seed Butter, Tocopherol.
*Organic

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

KIDS FACE AND BODY SUNSCREEN SPF 50 
zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73418-103
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	210 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
OLIVE OIL (UNII: 6UYK2W1W1E)
COCOA BUTTER (UNII: 512OYT1CRR)
SHEA BUTTER (UNII: K49155WL9Y)
CANDELILLA WAX (UNII: WL0328HX19)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
LEVOMENOL (UNII: 24WE03BX2T)
TOCOPHEROL (UNII: R0ZB2556P8)
COCONUT OIL (UNII: Q9L0O73W7L)
ORYZANOL (UNII: SST9XCL51M)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SUNFLOWER OIL (UNII: 3W1JG795YI)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73418-103-08	1 in 1 CARTON	09/30/2023
1	NDC: 73418-103-01	28 g in 1 CYLINDER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M020	09/30/2023

Labeler - Hello Bello (081135707)