Drug Factsactive Ingredient
Zinc Oxide 15.002%
Naturopathica
FDA Label NDC 54111-152
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bentley Laboratories, Llc for the product Naturopathica (NDC 54111-152). 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 drug factsactive ingredient, purpose, uses, warnings, otc - keep out of reach of children, directions, other information, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Sunscreen
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
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
Keep out of reach of children. If product is
swallowed, get medical help or contact a Poison
Control Center right away.
Directions
• 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
Protect the product in this container from excessive heat and direct sun
Otc - Questions
Questions or Comments? call toll free 646-979-3997
Inactive Ingredients
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
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
0.5 Fl OZ
res
* Please review the disclaimer below.
