NATUROPATHICA CALENDULA AND BUTTERFLY GINGER SPF 40- zinc oxide cream 
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 & BUTTERFLY GINGER EYE CREAM

Drug Facts        

Active Ingredient 

Zinc Oxide 19.92375%

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: Water (Aqua), Coco-Caprylate/Caprate,
Glycerin, Galactoarabinan, Butyloctyl Salicylate, Griffonia Simplicifolia Seed
Extract, Cetearyl Alcohol, Propanediol, Caprylic/Capric Triglyceride, Undaria
Pinnatifida Extract, Polyglyceryl-3 Polyricinoleate, Hydrogenated Lecithin,
Palmitic Acid, 1,2-Hexanediol, Borago Officinalis Seed Oil, Caprylyl Glycol,
Hydrolyzed Vegetable Protein, Xylitylglucoside, Isostearic Acid, Cetearyl
Glucoside, Xanthan Gum, Anhydroxylitol, Citric Acid, Trehalose, Camellia
Sinensis Leaf Extract, Lactobacillus Ferment Lysate, Punica Granatum Flower
Extract, Xylitol, Polyhydroxystearic Acid, Lecithin, Hedychium Coronarium
Root Extract, Lactobacillus Ferment, Leuconostoc/Radish Root Ferment
Filtrate, Polygonum Aviculare Extract, Caffeine, Potassium Sorbate, Sodium
Benzoate, Carthamus Tinctorius (Safflower) Seed Oil, Calendula Officinalis
Flower Extract, Xanthophylls

Product Label

NATUROPATHICA®

FOR DEEPER BEAUTY

CALENDULA &

BUTTERFLY GINGER

EYE CREAM

BROAD SPECTRUM SPF 40 SUNSCREEN

FLUIDE ESSENTIAL

HYDRATANT

0.5 FL OZ/50 ML

Distributed by: Naturopathica Holistic Health, Inc.

New York, NY 10001. Dublin, Ireland

Naturopathica.com 646-979-3997

153-50 Carton

153-50 Btl

res

NATUROPATHICA CALENDULA AND BUTTERFLY GINGER  SPF 40
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54111-153
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION19.92375 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
GLYCERIN (UNII: PDC6A3C0OX)  
GALACTOARABINAN (UNII: SL4SX1O487)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
GRIFFONIA SIMPLICIFOLIA SEED (UNII: LUS5142TMY)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
PROPANEDIOL (UNII: 5965N8W85T)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
UNDARIA PINNATIFIDA (UNII: ICV1OK7M1S)  
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
PALMITIC ACID (UNII: 2V16EO95H1)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
BORAGE SEED OIL (UNII: F8XAG1755S)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
XYLITYLGLUCOSIDE (UNII: O0IEZ166FB)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
XANTHAN GUM (UNII: TTV12P4NEE)  
ANHYDROXYLITOL (UNII: 8XWR7NN42F)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
TREHALOSE (UNII: B8WCK70T7I)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
PUNICA GRANATUM FLOWER (UNII: D9B634V4GP)  
XYLITOL (UNII: VCQ006KQ1E)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
HEDYCHIUM CORONARIUM ROOT (UNII: 92A6N0IQN9)  
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)  
POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)  
CAFFEINE (UNII: 3G6A5W338E)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
LUTEIN (UNII: X72A60C9MT)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54111-153-501 in 1 CARTON01/31/2021
115 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: 23b6d7f7-3a70-4aa6-9e94-3e7fef4891bd
Set id: 54bb7fd5-87f6-4747-902e-998fec764839
Version: 1
Effective Time: 20210210
 
Bentley Laboratories, LLC