KIDS FACE AND BODY SUNSCREEN SPF 50- zinc oxide stick 
Hello Bello

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.

----------

Face + Body Sun Stick SPF50

Drug Facts

Active Ingredients

Zinc Oxide 21.0%

Purpose

Sunscreen

Uses

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

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

HelloBello-sunscreen-family-stick_BIORIUS_Aug2023_AOHelloBello-sunscreen-family-stick-box_BIORIUS_Aug2023_AO

KIDS FACE AND BODY SUNSCREEN SPF 50 
zinc oxide stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73418-103
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE210 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73418-103-081 in 1 CARTON09/30/2023
1NDC:73418-103-0128 g in 1 CYLINDER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02009/30/2023
Labeler - Hello Bello (081135707)

Revised: 9/2023
Document Id: 01cc4ea0-e3df-32f1-e063-6394a90a1375
Set id: 01cc4ea0-e3de-32f1-e063-6394a90a1375
Version: 1
Effective Time: 20230930
 
Hello Bello