FDA.reportPublic FDA data

Invisible Hero SPF30

Manufacturer
Clark's Botanicals, LLC | Products by O2, Inc.
Effective date
2021-08-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:41:45

Label at a glance#

ProductInvisible Hero SPF30
Active ingredientZINC OXIDE
Label structure10 sections

Indications and uses

Helps prevent sunburn

Dosage and administration

Apply liberally at least 15 minutes before sun exposure Apply as the last step in your skincare routine Use a water resistant sunscreen if swimming or sweating Reapply at least every 2 hours 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 of 15 or higer and other sun protection measu...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide, 15%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

Helps prevent sunburn

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally at least 15 minutes before sun exposure
  • Apply as the last step in your skincare routine
  • Use a water resistant sunscreen if swimming or sweating
  • Reapply at least every 2 hours

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 of 15 or higer and other sun protection measures includuing:
- Limit time in the sun, especailly from 10 AM to 2 PM
- Wear long-sleeve shirts, pants, hats, and sunglasses


  • Children under 6 months: Ask a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Coco-Caprylate, Glycerin, Sorbitan Olivate, C15-19 Alkane, C12-15 Alkyl Benzoate, Cetearyl Olivate, Coco-Glucoside, Xylitylglucoside, Coconut Alcohol, Zinc Sulfate, Anhydroxylitol, Jasminum Officinale (Jasmine) Extract, Arnica Montana (Arnica) Flower Extract, Hypnea Musciformis (Algae) Extract, Niacinamide, Vitis Vinifera (Grape) Leaf Extract, Inula Helenium (Elecampane) Extract, Sodium hyaluronate, Radish Root Ferment Filtrate, Polyhydroxystearic Acid, Trimethylolpropane Triethylhexanoate, Cetyl Ethylhexanoate, Sodium Phytate, Xanthan Gum, Caprylhydroxamic Acid, Glyceryl Caprylate, Benzyl Alcohol, Benzoic Acid, Natural Fragrance, Geraniol, Linalool, d -Limonene, Eugenol

Other Warnings

SPL UNCLASSIFIED SECTION

Protect this product from excessive heat and direct sun

Questions or Comments

SPL UNCLASSIFIED SECTION

Call 1-917-970-1250 (9 AM to 5 PM ET)

SPL UNCLASSIFIED SECTION

Distributed by Clark's Botanicals, LLC
Bronxville, NY
clarksbotanicals.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Clark's Botanicals
Invisible Hero SPF 30
Anti-Aging Sunscreen with Hyaluronic Acid
Broad Spectrum SPF 30 PA+++

Poids Net Wt. 1.7 fl. oz.| 50 mL

CBHeroCBHero

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82071-042-022023-01-30C16284748780-1f386c649-f7b3-0266-e053-dadaa90a7c1af84d8601-3526-4d85-9e38-30fd9e8e187b

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82071-042-02Invisible Hero SPF3050 mL in 1 BOTTLE, PUMPLIQUID501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82071-042INVISIBLE HERO SPF30 (SUNSCREEN) LIQUID [CLARK'S BOTANICALS, LLC]1Legacy NDC, 1 package rows20210802_f84d8601-3526-4d85-9e38-30fd9e8e187b.zip

Products#

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

DailyMed product names page 1 of 1 · 37 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82071-04282071-042-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 34 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIM
WATER059QF0KO0RIACT
COCO-CAPRYLATE4828G836N6IACT
GLYCERINPDC6A3C0OXIACT
SORBITAN OLIVATEMDL271E3GRIACT
C15-19 ALKANECI87N1IM01IACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
CETEARYL OLIVATE58B69Q84JOIACT
COCO GLUCOSIDEICS790225BIACT
XYLITYLGLUCOSIDEO0IEZ166FBIACT
COCONUT ALCOHOL13F4MW8Y9KIACT
ZINC SULFATE89DS0H96TBIACT
ANHYDROXYLITOL8XWR7NN42FIACT
JASMINUM OFFICINALE FRUITRFR735L94AIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
HYPNEA MUSCIFORMISW6FF9R1FJVIACT
NIACINAMIDE25X51I8RD4IACT
VITIS VINIFERA LEAFR1H893D80EIACT
INULA HELENIUM ROOTE55SMD6DA8IACT
HYALURONATE SODIUMYSE9PPT4THIACT
RADISHEM5RP35463IACT
POLYHYDROXYSTEARIC ACID STEARATE8KQ7I65XZEIACT
TRIMETHYLOLPROPANE090GDF4HBDIACT
CETYL ETHYLHEXANOATE134647WMX4IACT
PHYTATE SODIUM88496G1ERLIACT
XANTHAN GUMTTV12P4NEEIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
GLYCERYL MONOCAPRYLATETM2TZD4G4AIACT
BENZYL ALCOHOLLKG8494WBHIACT
BENZOIC ACID8SKN0B0MIMIACT
GERANIOLL837108USYIACT
LINALOOL, (+/-)-D81QY6I88EIACT
LIMONENE, (+)-GFD7C86Q1WIACT
EUGENOL3T8H1794QWIACT

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
010d36fb-a57d-4f24-bab3-7bba47fe2c13f84d8601-3526-4d85-9e38-30fd9e8e187b2021-08-01WarningsExact identifier
spl id: 010d36fb-a57d-4f24-bab3-7bba47fe2c13
spl set id: f84d8601-3526-4d85-9e38-30fd9e8e187b

Reported adverse events (FAERS/openFDA)#

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