Hello by Hello Products LLC / Autumn Harp Hello®

Hello by

Drug Labeling and Warnings

Hello by is a Otc medication manufactured, distributed, or labeled by Hello Products LLC, Autumn Harp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

HELLO 
zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55882-6115
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	9.2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55882-6115-1	1 in 1 BOX	06/15/2021	03/31/2024
1		4.2 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	06/15/2021	03/31/2024

Labeler - Hello Products LLC (040714890)

Establishment
Name	Address	ID/FEI	Business Operations
Autumn Harp		064187883	MANUFACTURE(55882-6115)

Revised: 5/2021

Document Id: a37a49bf-8491-4b0b-8b05-d8b0b816c109

34390-5

Set id: b3e2178a-112d-491a-99a6-32d248af8e60

Version: 2

Effective Time: 20210513