HELLO- zinc oxide stick 
Hello Products 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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Hello®

Drug Facts

Active ingredient

Zinc Oxide 9.20%

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 damaged or broken 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 product is swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222

Directions

  • apply liberally 15 minutes before sun exposure
  • reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
  • children under 6 months: 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-sleeve shirts, pants, hats, and sunglasses

Other information

  • protect this product from excessive heat (over 103° F) and direct sun

Inactive ingredients

Ricinus Communis (Castor) Seed Oil, Isoamyl Laurate, Olea Europaea (Olive) Fruit Oil, Euphorbia Cerifera (Candelilla) Wax, Cocos Nucifera (Coconut) Oil, Caprylic/Capric Triglyceride, Theobroma Cacao (Cocoa) Seed Butter, Behenyl Behenate, Butyrospermum Parkii (Shea) Butter, Lauryl Laurate, Polyhydroxystearic Acid, Hydrogenated Olive Oil, Limnanthes Alba (Meadowfoam) Seed Oil, Flavor, Triethoxycaprylylsilane, Olea Europaea (Olive) Oil Unsaponifiables, Citrus Aurantium Dulcis (Orange) Peel Extract, Tocopherol, Stevia Rebaudiana Leaf/Stem Extract1, Glycine Soja (Soybean) Oil.

1
Denotes organic

Questions?

Call: 855-HI-HELLO (1-855-444-3556)

Dist. by Hello Products LLC
Montclair, NJ 07042

PRINCIPAL DISPLAY PANEL - 4.2 g Tube Box

naturally
friendly™

hello®

vegan lip balm

broad spectrum SPF 15

sweet mint
with coconut oil

never tested
on animals

protects + moisturizes

no beeswax. no petrolatum.
no parabens. no brainer.

water resistant (80 minutes).
8 hour moisturization.

NET WT 0.15 OZ (4.2 g)

PRINCIPAL DISPLAY PANEL - 4.2 g Tube Box
HELLO 
zinc oxide stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55882-6115
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE9.2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CASTOR OIL (UNII: D5340Y2I9G)  
ISOAMYL LAURATE (UNII: M1SLX00M3M)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
CANDELILLA WAX (UNII: WL0328HX19)  
COCONUT OIL (UNII: Q9L0O73W7L)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
COCOA BUTTER (UNII: 512OYT1CRR)  
BEHENYL BEHENATE (UNII: K8NU647RJ0)  
LAURYL LAURATE (UNII: GPW77G0937)  
SHEA BUTTER (UNII: K49155WL9Y)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
HYDROGENATED OLIVE OIL (UNII: 53839415GI)  
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES (UNII: XO45V955LT)  
ORANGE PEEL WAX (UNII: 0U715N387C)  
TOCOPHEROL (UNII: R0ZB2556P8)  
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
SOYBEAN OIL (UNII: 241ATL177A)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55882-6115-11 in 1 BOX06/15/202103/31/2024
14.2 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35206/15/202103/31/2024
Labeler - Hello Products LLC (040714890)
Establishment
NameAddressID/FEIBusiness Operations
Autumn Harp064187883MANUFACTURE(55882-6115)

Revised: 5/2021
Document Id: a37a49bf-8491-4b0b-8b05-d8b0b816c109
Set id: b3e2178a-112d-491a-99a6-32d248af8e60
Version: 2
Effective Time: 20210513
 
Hello Products LLC