Naturopathica: Package Insert and Label Information

NATUROPATHICA- zinc oxide lotion
Bentley Laboratories, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts Active Ingredient

Zinc Oxide 15.002%

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

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

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 OfficinalisFlower 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

152-50 50mL Box
(click image for full-size original)
152-51 50mL Btl
(click image for full-size original)

0.5 Fl OZ

152-51 15mL Box
(click image for full-size original)
152-51 15mL Btl
(click image for full-size original)

res

NATUROPATHICA zinc oxide lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:54111-152
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE (ZINC CATION) ZINC CATION 15.002 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
COCO-CAPRYLATE/CAPRATE
ALKYL (C12-15) BENZOATE
GALACTOARABINAN
GLYCERIN
TRIETHYL CITRATE
CETOSTEARYL ALCOHOL
DOCOSANOL
BUTYLOCTYL SALICYLATE
PROPANEDIOL
CETEARYL GLUCOSIDE
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES
SODIUM STEAROYL GLUTAMATE
LAVENDER OIL
LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWERING TOP
ROSA DAMASCENA FLOWER OIL
TAGETES MINUTA FLOWER OIL
CITRUS SINENSIS FLOWER OIL
ETHYL FERULATE
UNDARIA PINNATIFIDA
POLYGLYCERYL-3 PENTARICINOLEATE
GLYCERYL CAPRYLATE
BORAGE SEED OIL
HYDROXYACETOPHENONE
XYLITYLGLUCOSIDE
COCO GLUCOSIDE
LEVOMENOL
XANTHAN GUM
ISOSTEARIC ACID
ANHYDROXYLITOL
CITRIC ACID MONOHYDRATE
XYLITOL
CAPRYLHYDROXAMIC ACID
POLYGONUM AVICULARE TOP
POTASSIUM SORBATE
SODIUM BENZOATE
SAFFLOWER OIL
CALENDULA OFFICINALIS FLOWER
TREHALOSE
LUTEIN
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54111-152-50 1 JAR in 1 CARTON contains a JAR
1 50 mL in 1 JAR This package is contained within the CARTON (54111-152-50)
2 NDC:54111-152-51 1 JAR in 1 CARTON contains a JAR
2 15 mL in 1 JAR This package is contained within the CARTON (54111-152-51)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 01/31/2021
Labeler — Bentley Laboratories, LLC (068351753)

Revised: 02/2021 Bentley Laboratories, LLC

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