Calendula Essential Hydrating Broad Spectrum SPF 30 Sunscreen

Manufacturer
Naturopathica Holistic Health
Effective date
2025-10-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:41:54

Label at a glance#

ProductCalendula Essential Hydrating Broad Spectrum SPF 30 Sunscreen
Active ingredientZINC OXIDE
Label structure13 sections

Dosage and administration

Directions Apply liberally 15 minutes before sun exposure Reapply at least every 2 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 value of 15 or higher and other sun protection measures including: limit time in the sun, ...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Purpose

Zinc Oxide 15% ..............................................Sunscreen

Purpose

OTC - PURPOSE SECTION

Purpose

Zinc Oxide 15%..............................................Sunscreen

INDICATIONS & USAGE SECTION

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 SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

keep outof eyes.

Rinse with water to remove

OTC - ASK DOCTOR 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

Directions

Apply liberally 15 minutes before sun exposure

Reapply at least every 2 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 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-sleeved shirts, pants, hats and sunglasses

Children under 6 months of age: ask a doctor

OTHER SAFETY INFORMATION

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

OTC - QUESTIONS SECTION

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

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Water (Aqua), Caprylic/Capric Triglyceride, Butyloctyl Salicylate, Feruloyl Soy Glycerides, Polyglyceryl-6 Distearate, Glycerin, Betaine, Propanediol, Tapioca Starch, Glyceryl Stearate, Sorbitan Sesquioleate, Aloe Barbadensis Leaf Juice, Calendula Officinalis Flower Extract, Allantoin, Bisabolol, Hyaluronic Acid, Squalane, Simmondsia Chinensis (Jojoba) Seed Oil, Pongamia Pinnata Seed Extract, Lavandula Angustifolia (Lavender) Oil, Glyceryl Caprylate, Dilheptyl Succinate, Polyhydroxystearic Acid, Sodium Stearoyl Glutamate, Tocopheryl Acetate, Xanthan Gum, Capryloyl Glycerin/Sebacic Acid Copolymer, Sodium PCA, Tocopherol, Caprylhydroxamic Acid, Glycine Soja (Soybean) Oil, Citric Acid, Iron Oxides (Cl 77492), Citrus Aurantium Amara (Bitter Orange) Peel Oil, Rosa Damascena Flower Oil, Tagetes Minuta Flower Oil, Borago Officinalis (Common Borage), Jojoba Esters, Polyglyceryl-6 Polyricinoleate, Silica, Polygonum Aviculare Extract, Linalool, Linalyl Acetate, Lavandula Oil / Extract

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1c9d1af-bddd-448d-86f7-69052b7d5b47Product name120220627

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64657-007-01Calendula Essential Hydrating Broad Spectrum SPF 30 Sunscreen65 mL in 1 TUBELOTION651
64657-007-02Calendula Essential Hydrating Broad Spectrum SPF 30 Sunscreen1 in 1 CARTONLOTION11

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64657-00764657-007-01, 64657-007-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 39 matching rows.

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
Calendula Essential Hydrating Broad Spectrum SPF 30 SunscreenZINC OXIDENaturopathica Holistic Health41d75815-e281-bf88-e063-6294a90afeff2025-10-23WarningsExact identifier
ndc (package): 64657-007-02
ndc (package): 64657-007-01
ndc (product): 64657-007
ndc11 (package): 64657000702
ndc11 (package): 64657000701
spl id: 41d75815-e282-bf88-e063-6294a90afeff
spl set id: 41d75815-e281-bf88-e063-6294a90afeff

Reported adverse events (FAERS/openFDA)#

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