FDA.reportPublic FDA data

Hello

Manufacturer
Hello Products LLC | Autumn Harp
Effective date
2022-02-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:35:02

Label at a glance#

ProductHello
Active ingredientZINC OXIDE
Label structure11 sections

Dosage and administration

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 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: limi...

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 9.20%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Use(s)

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • 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

SPL UNCLASSIFIED SECTION

  • 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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

1 Denotes organic

Other information

STORAGE AND HANDLING SECTION

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

Questions?

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

Dist. by Hello Products LLC
Montclair, NJ 07042

PRINCIPAL DISPLAY PANEL - 4.2 g Tube Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

naturally
friendly™
hello®

vegan lip balm

broad spectrum SPF 15

strawberry
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
PRINCIPAL DISPLAY PANEL - 4.2 g Tube Box

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55882-612055882-6120-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIM
CASTOR OILD5340Y2I9GIACT
ISOAMYL LAURATEM1SLX00M3MIACT
OLIVE OIL6UYK2W1W1EIACT
CANDELILLA WAXWL0328HX19IACT
COCONUT OILQ9L0O73W7LIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
COCOA BUTTER512OYT1CRRIACT
BEHENYL BEHENATEK8NU647RJ0IACT
LAURYL LAURATEGPW77G0937IACT
SHEA BUTTERK49155WL9YIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
HYDROGENATED OLIVE OIL53839415GIIACT
MEADOWFOAM SEED OIL412ZHA4T4YIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLESXO45V955LTIACT
ORANGE PEEL WAX0U715N387CIACT
TOCOPHEROLR0ZB2556P8IACT
STEVIA REBAUDIUNA LEAF6TC6NN0876IACT
SOYBEAN OIL241ATL177AIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
00e007f7-b352-42a2-a060-96a1f3e522bdfdb03e82-9754-416d-acef-7624b92ef0432022-02-07WarningsExact identifier
spl id: 00e007f7-b352-42a2-a060-96a1f3e522bd
spl set id: fdb03e82-9754-416d-acef-7624b92ef043

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.