FDA.reportPublic FDA data

NATUROPATHICA CALENDULA & BUTTERFLY GINGER EYE CREAM

Manufacturer
Bentley Laboratories, LLC
Effective date
2021-02-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:37:58

Label at a glance#

ProductNaturopathica Calendula and Butterfly Ginger SPF 40
Active ingredientZINC OXIDE
Label structure10 sections

Indications and 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

Dosage and administration

• apply liberally 15 minutes before sun exposure • reapply at least every two hours • use a water resistant sunscreen if swimming or sweating • 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 15 or higher and other    sun protection measures including: • limit time in th...

Label contents#

Full prescribing information#

Drug Facts        

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient 

Zinc Oxide 19.92375%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

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
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

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.

Directions

DOSAGE & ADMINISTRATION SECTION

• apply liberally 15 minutes before sun exposure
• reapply at least every two hours
• use a water resistant sunscreen if swimming or sweating
• 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 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
• children under 6 months of age: consult a doctor

Other Information

OTHER SAFETY INFORMATION

Protect the product in this container from excessive heat and direct sun

OTC - QUESTIONS SECTION

Questions or Comments? call toll free 646-979-3997

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Water (Aqua), Coco-Caprylate/Caprate,
Glycerin, Galactoarabinan, Butyloctyl Salicylate, Griffonia Simplicifolia Seed
Extract, Cetearyl Alcohol, Propanediol, Caprylic/Capric Triglyceride, Undaria
Pinnatifida Extract, Polyglyceryl-3 Polyricinoleate, Hydrogenated Lecithin,
Palmitic Acid, 1,2-Hexanediol, Borago Officinalis Seed Oil, Caprylyl Glycol,
Hydrolyzed Vegetable Protein, Xylitylglucoside, Isostearic Acid, Cetearyl
Glucoside, Xanthan Gum, Anhydroxylitol, Citric Acid, Trehalose, Camellia
Sinensis Leaf Extract, Lactobacillus Ferment Lysate, Punica Granatum Flower
Extract, Xylitol, Polyhydroxystearic Acid, Lecithin, Hedychium Coronarium
Root Extract, Lactobacillus Ferment, Leuconostoc/Radish Root Ferment
Filtrate, Polygonum Aviculare Extract, Caffeine, Potassium Sorbate, Sodium
Benzoate, Carthamus Tinctorius (Safflower) Seed Oil, Calendula Officinalis
Flower Extract, Xanthophylls

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NATUROPATHICA®

FOR DEEPER BEAUTY

CALENDULA &

BUTTERFLY GINGER

EYE CREAM

BROAD SPECTRUM SPF 40 SUNSCREEN

FLUIDE ESSENTIAL

HYDRATANT

0.5 FL OZ/50 ML

Distributed by: Naturopathica Holistic Health, Inc.

New York, NY 10001. Dublin, Ireland

Naturopathica.com 646-979-3997

153-50 Carton153-50 Carton

153-50 Btl153-50 Btl

res

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54111-153-502023-01-30C16284748780-1f386c649-e813-0266-e053-dadaa90a7c1aNATUROPATHICA CALENDULA & BUTTERFLY GINGER EYE CREAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54111-153-50Naturopathica Calendula and Butterfly GingerSPF 4015 mL in 1 JARCREAM151
54111-153-50Naturopathica Calendula and Butterfly GingerSPF 401 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54111-153NATUROPATHICA CALENDULA AND BUTTERFLY GINGER SPF 40 (ZINC OXIDE) CREAM [BENTLEY LABORATORIES, LLC]1Legacy NDC, 2 package rows20210211_54bb7fd5-87f6-4747-902e-998fec764839.zip

Products#

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

DailyMed product names page 1 of 1 · 40 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54111-15354111-153-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 38 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIM
WATER059QF0KO0RIACT
COCO-CAPRYLATE/CAPRATE8D9H4QU99HIACT
GLYCERINPDC6A3C0OXIACT
GALACTOARABINANSL4SX1O487IACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
GRIFFONIA SIMPLICIFOLIA SEEDLUS5142TMYIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
PROPANEDIOL5965N8W85TIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
UNDARIA PINNATIFIDAICV1OK7M1SIACT
POLYGLYCERYL-3 PENTARICINOLEATE7Q0OK5DOT4IACT
HYDROGENATED SOYBEAN LECITHINH1109Z9J4NIACT
PALMITIC ACID2V16EO95H1IACT
1,2-HEXANEDIOLTR046Y3K1GIACT
BORAGE SEED OILF8XAG1755SIACT
CAPRYLYL GLYCOL00YIU5438UIACT
XYLITYLGLUCOSIDEO0IEZ166FBIACT
ISOSTEARIC ACIDX33R8U0062IACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
XANTHAN GUMTTV12P4NEEIACT
ANHYDROXYLITOL8XWR7NN42FIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
TREHALOSEB8WCK70T7IIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
PUNICA GRANATUM FLOWERD9B634V4GPIACT
XYLITOLVCQ006KQ1EIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
HEDYCHIUM CORONARIUM ROOT92A6N0IQN9IACT
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATED2QHA03458IACT
POLYGONUM AVICULARE TOPZCD6009IUFIACT
CAFFEINE3G6A5W338EIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SODIUM BENZOATEOJ245FE5EUIACT
SAFFLOWER OIL65UEH262ISIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
LUTEINX72A60C9MTIACT

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
23b6d7f7-3a70-4aa6-9e94-3e7fef4891bd54bb7fd5-87f6-4747-902e-998fec7648392021-02-10WarningsExact identifier
spl id: 23b6d7f7-3a70-4aa6-9e94-3e7fef4891bd
spl set id: 54bb7fd5-87f6-4747-902e-998fec764839

Reported adverse events (FAERS/openFDA)#

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