Active Ingredients
Purpose
Zinc Oxide 15% ..............................................Sunscreen
Calendula Essential Hydrating Broad Spectrum Spf 30 Sunscreen Lotion
FDA Label NDC 64657-007
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Naturopathica Holistic Health for the product Calendula Essential Hydrating Broad Spectrum Spf 30 Sunscreen (NDC 64657-007). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - ask doctor, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Purpose
Zinc Oxide 15%..............................................Sunscreen
Indications & Usage
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
For external use only
Otc - Do Not Use
Do not use on damaged or broken skin
Otc - When Using
keep outof eyes.
Rinse with water to remove
Otc - Ask Doctor
Stop use and ask a doctor if rash occurs
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
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
Questions or Commets? call toll free 646-979-3997
Inactive Ingredient
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
* Please review the disclaimer below.
