Label: NATUROPATHICA CALENDULA AND BUTTERFLY GINGER SPF 40- zinc oxide cream
-
Contains inactivated NDC Code(s)
NDC Code(s): 54111-153-50 - Packager: Bentley Laboratories, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 Label Information
Updated February 10, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Purpose
- Uses
- Warnings
- KEEP OUT OF REACH OF CHILDREN
-
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
- QUESTIONS
-
INACTIVE INGREDIENT
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
-
INGREDIENTS AND APPEARANCE
NATUROPATHICA CALENDULA AND BUTTERFLY GINGER SPF 40
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54111-153 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 19.92375 g in 100 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:54111-153-50 1 in 1 CARTON 01/31/2021 1 15 mL in 1 JAR; Type 0: Not a Combination Product 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)
