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.

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NATUROPATHICA CALENDULA ESSENTIAL HYDRATING LOTION

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 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

152-50 50mL Box

152-51 50mL Btl

0.5 Fl OZ

152-51 15mL Box

152-51 15mL Btl

res

NATUROPATHICA 
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54111-152
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION15.002 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
GALACTOARABINAN (UNII: SL4SX1O487)  
GLYCERIN (UNII: PDC6A3C0OX)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
DOCOSANOL (UNII: 9G1OE216XY)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
PROPANEDIOL (UNII: 5965N8W85T)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)  
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)  
ROSA DAMASCENA FLOWER OIL (UNII: 18920M3T13)  
TAGETES MINUTA FLOWER OIL (UNII: 1T0ZMU8M8B)  
CITRUS SINENSIS FLOWER OIL (UNII: AJ56JP5TFP)  
ETHYL FERULATE (UNII: 5B8915UELW)  
UNDARIA PINNATIFIDA (UNII: ICV1OK7M1S)  
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
BORAGE SEED OIL (UNII: F8XAG1755S)  
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
XYLITYLGLUCOSIDE (UNII: O0IEZ166FB)  
COCO GLUCOSIDE (UNII: ICS790225B)  
LEVOMENOL (UNII: 24WE03BX2T)  
XANTHAN GUM (UNII: TTV12P4NEE)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
ANHYDROXYLITOL (UNII: 8XWR7NN42F)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
XYLITOL (UNII: VCQ006KQ1E)  
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
TREHALOSE (UNII: B8WCK70T7I)  
LUTEIN (UNII: X72A60C9MT)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54111-152-501 in 1 CARTON01/31/2021
150 mL in 1 JAR; Type 0: Not a Combination Product
2NDC:54111-152-511 in 1 CARTON01/31/2021
215 mL in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34701/31/2021
Labeler - Bentley Laboratories, LLC (068351753)

Revised: 2/2021
Document Id: 5e6f4f7c-4d15-4c81-b82a-7caa9f838a26
Set id: 60e9456d-4cbf-4222-8f37-0e78c33cc792
Version: 1
Effective Time: 20210201
 
Bentley Laboratories, LLC