MyChelle® Dermaceuticals Daily Defense Cream  SPF 17 Broad Spectrum

Drug Labeling and Warnings

Drug Details [pdf]

MYCHELLE DERMACEUTICALS DAILY DEFENSE  SPF 17 BROAD SPECTRUM- zinc oxide cream 
French Transit, Ltd.

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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MyChelle® Dermaceuticals Daily Defense Cream
 SPF 17 Broad Spectrum

DRUG FACTS

Active Ingredient

Zinc Oxide 7%

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 and irritation develops and lasts.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • For daily use, allow product to absorb completely before applying make-up.
  • Apply liberally 15 minutes before sun exposure.
  • Use a water resistant sunscreen if swimming or sweating.
  • Reapply at least every 2 hours.
  • 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 of 15 or higher and other sun protection measures including:
    • Limit time in the sun, especially from 10 a.m. – 2 p.m.
    • Wear long-sleeve shirts, pants, hats and sunglasses.
    • Children under 6 months: Ask a doctor.

Inactive Ingredients

1,2-Hexanediol, Alcohol Denat., Aqua (Water), Astaxanthin, Beta-Glucan (D), Caprylic/Capric Triglyceride, Caprylyl Glycol, Cetearyl Olivate, Citric Acid, Cyclopentasiloxane, Elaeis Guineensis (Palm) Oil, Gluconolactone, Glycerin, Glyceryl Isostearate, Glycine Soja (Soybean) Oil, Leuconostoc/Radish Root Ferment Filtrate, Lonicera Caprifolium (Honeysuckle) Flower Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Magnesium Aluminum Silicate, Olea Europaea (Olive) Fruit Oil, Phytic Acid, Polyhydroxystearic Acid, Populus Tremuloides Bark Extract, Potassium Sorbate, Simmondsia Chinensis (Jojoba) Seed Oil, Sorbitan Olivate, Squalane, Tetrahydrobisdemethoxydiferuloylmethane, Tetrahydrodemethoxydiferuloylmethane, Tetrahydrodiferuloylmethane, Tocopherol (D-alpha), Tocopheryl Acetate (D-alpha), Tocotrienols, Triticum Vulgare (Wheat) Germ Oil, Tropolone, Xanthan Gum

Other Information

Protect this product from excessive heat and direct sun.

PRINCIPAL DISPLAY PANEL - 35 mL Tube Box

SUN
PROTECTION

Daily Defense
Cream

SPF 17

Broad Spectrum

REEF
SAFE

MyChelle®
dermaceuticals

1.2 fl oz / 35mL

PRINCIPAL DISPLAY PANEL - 35 mL Tube Box
MYCHELLE DERMACEUTICALS DAILY DEFENSE   SPF 17 BROAD SPECTRUM
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 72805-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide7 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
Cetearyl Olivate (UNII: 58B69Q84JO)  
Glycerin (UNII: PDC6A3C0OX)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
Sorbitan Olivate (UNII: MDL271E3GR)  
Squalane (UNII: GW89575KF9)  
WHEAT GERM OIL (UNII: 14C97E680P)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
JOJOBA OIL (UNII: 724GKU717M)  
Astaxanthin (UNII: 8XPW32PR7I)  
.ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
Tetrahydrodiferuloylmethane (UNII: 00U0645U03)  
Tetrahydrobisdemethoxydiferuloylmethane (UNII: 973IBV8W7I)  
Tetrahydrodemethoxydiferuloylmethane (UNII: 44D8X9U00T)  
SOYBEAN OIL (UNII: 241ATL177A)  
POPULUS TREMULOIDES BARK (UNII: 5543O0CEID)  
Leuconostoc/Radish Root Ferment Filtrate (UNII: D2QHA03458)  
Tropolone (UNII: 7L6DL16P1T)  
Tocotrienols (UNII: KP2MW85SSQ)  
LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)  
LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U)  
Gluconolactone (UNII: WQ29KQ9POT)  
PALM OIL (UNII: 5QUO05548Z)  
Glyceryl Isostearate (UNII: HYE7O27HAO)  
Caprylyl Glycol (UNII: 00YIU5438U)  
Magnesium Aluminum Silicate (UNII: 6M3P64V0NC)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
1,2-Hexanediol (UNII: TR046Y3K1G)  
ALCOHOL (UNII: 3K9958V90M)  
Xanthan Gum (UNII: TTV12P4NEE)  
FYTIC ACID (UNII: 7IGF0S7R8I)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
Potassium Sorbate (UNII: 1VPU26JZZ4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 72805-010-351 in 1 BOX11/01/201712/31/2019
135 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35211/01/201712/31/2019
Labeler - French Transit, Ltd. (100044380)

Revised: 2/2019
 

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