FDA.reportPublic FDA data

NATUROPATHICA CALENDULA ESSENTIAL HYDRATING LOTION

Manufacturer
Bentley Laboratories, LLC
Effective date
2021-02-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:37:48

Label at a glance#

ProductNaturopathica
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 FactsActive Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 15.002%

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 Ingredients

INACTIVE INGREDIENT SECTION

Aqua/Water/Eau,
Coco-Caprylate/Caprate, C12-15 Alkyl Benzoate,
Galactoarabinan, Glycerin, Triethyl Citrate,
Cetearyl Alcohol, Behenyl Alcohol, Butyloctyl
Salicylate, Propanediol, Cetearyl Glucoside,
Carthamus Tinctorius (Safflower) Oleosomes, Sodium
Stearoyl Glutamate, Lavandula Angustifolia
(Lavender) Oil, Lavandula Angustifolia (Lavender)
Flower/Leaf/Stem Extract, Rosa Damascena Flower
Oil, Tagetes Minuta Flower Oil, Citrus Aurantium Dulcis
(Orange) Flower Oil, Ethyl Ferulate, Undaria
Pinnatifida Extract, Polyglyceryl-3 Polyricinoleate,
Glyceryl Caprylate, Borago Officinalis Seed Oil,
Hydroxyacetophenone, Xylitylglucoside,
Coco-Glucoside, Bisabolol, Xanthan Gum, Isostearic
Acid, Anhydroxylitol, Citric Acid, Xylitol,
Caprylhydroxamic Acid, Polygonum Aviculare Extract,
Potassium Sorbate, Sodium Benzoate, Carthamus
Tinctorius (Safflower) Seed Oil, Calendula Officinalis
Flower Extract, Trehalose, Xanthophylls


Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NATUROPATHICA®

FOR DEEPER BEAUTY

CALENDULA

ESSENTIAL

HYDRATING LOTION

BROAD SPECTRUM

SPF 30 SUNSCREEN

FLUIDE ESSENTIAL

HYDRATANT

1.7 Fl. OZ /50 ML

Distributed by:

Naturopathica Holistic Health

New York, NY 10001. Dublin, Ireland

Naturopathica.com 646-979-3997

1.7 Fl OZ

152-50 50mL Box152-50 50mL Box

152-51 50mL Btl152-51 50mL Btl

0.5 Fl OZ

152-51 15mL Box152-51 15mL Box

152-51 15mL Btl152-51 15mL 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
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54111-152-502023-01-30C16284748780-1f386c649-a159-0266-e053-dadaa90a7c1aNATUROPATHICA CALENDULA ESSENTIAL HYDRATING LOTION
54111-152-512023-01-30C16284748780-1f386c649-a159-0266-e053-dadaa90a7c1aNATUROPATHICA CALENDULA ESSENTIAL HYDRATING LOTION

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54111-152-50Naturopathica50 mL in 1 JARLOTION501
54111-152-50Naturopathica1 in 1 CARTONLOTION11
54111-152-51Naturopathica1 in 1 CARTONLOTION11
54111-152-51Naturopathica15 mL in 1 JARLOTION151

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54111-152NATUROPATHICA (ZINC OXIDE) LOTION [BENTLEY LABORATORIES, LLC]1Legacy NDC, 4 package rows20210206_60e9456d-4cbf-4222-8f37-0e78c33cc792.zip

Products#

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

DailyMed product names page 1 of 2 · 43 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54111-15254111-152-50, 54111-152-51

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 41 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIM
WATER059QF0KO0RIACT
COCO-CAPRYLATE/CAPRATE8D9H4QU99HIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
GALACTOARABINANSL4SX1O487IACT
GLYCERINPDC6A3C0OXIACT
TRIETHYL CITRATE8Z96QXD6UMIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
DOCOSANOL9G1OE216XYIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
PROPANEDIOL5965N8W85TIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES9S60Q72309IACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
LAVENDER OILZBP1YXW0H8IACT
LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWERING TOP9YT4B71U8PIACT
ROSA DAMASCENA FLOWER OIL18920M3T13IACT
TAGETES MINUTA FLOWER OIL1T0ZMU8M8BIACT
CITRUS SINENSIS FLOWER OILAJ56JP5TFPIACT
ETHYL FERULATE5B8915UELWIACT
UNDARIA PINNATIFIDAICV1OK7M1SIACT
POLYGLYCERYL-3 PENTARICINOLEATE7Q0OK5DOT4IACT
GLYCERYL CAPRYLATETM2TZD4G4AIACT
BORAGE SEED OILF8XAG1755SIACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
XYLITYLGLUCOSIDEO0IEZ166FBIACT
COCO GLUCOSIDEICS790225BIACT
LEVOMENOL24WE03BX2TIACT
XANTHAN GUMTTV12P4NEEIACT
ISOSTEARIC ACIDX33R8U0062IACT
ANHYDROXYLITOL8XWR7NN42FIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
XYLITOLVCQ006KQ1EIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
POLYGONUM AVICULARE TOPZCD6009IUFIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SODIUM BENZOATEOJ245FE5EUIACT
SAFFLOWER OIL65UEH262ISIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
TREHALOSEB8WCK70T7IIACT

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
5e6f4f7c-4d15-4c81-b82a-7caa9f838a2660e9456d-4cbf-4222-8f37-0e78c33cc7922021-02-01WarningsExact identifier
spl id: 5e6f4f7c-4d15-4c81-b82a-7caa9f838a26
spl set id: 60e9456d-4cbf-4222-8f37-0e78c33cc792

Reported adverse events (FAERS/openFDA)#

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