Label: MYCHELLE DERMACEUTICALS SUN SHIELD SPF 28 UNSCENTED PROTECT- zinc oxide and titanium dioxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 72805-061-68 - Packager: French Transit, Ltd.
- 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 January 6, 2022
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
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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
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Directions
- SHAKE WELL BEFORE USE.
- For daily use, apply to clean, dry skin and allow to absorb completely before applying makeup.
- Apply liberally 15 minutes before sun exposure.
- Use a water resistant sunscreen if swimming or sweating.
- Reapply at least every 2 hours.
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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.
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Inactive Ingredients
1,2-Hexanediol, Allantoin, Aloe Barbadensis Leaf Juice Powder, Alumina, Aqua (Water), Caprylic/Capric Triglyceride, Caprylyl Glycol, Cetearyl Alcohol, Cetearyl Glucoside, Citric Acid, Coco-Caprylate/Caprate, Dicaprylyl Ether, Fructooligosaccharides (D-beta), Gluconolactone, Glycerin, Glyceryl Isostearate, Glycine Soja (Soybean) Oil, Isononyl Isononanoate, Leuconostoc/ Radish Root Ferment Filtrate, Lonicera Caprifolium (Honeysuckle) Flower Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Magnesium Aluminum Silicate, Polyglyceryl-6 Polyricinoleate, Polyhydroxystearic Acid, Polysorbate 60, Populus Tremuloides Bark Extract, Potassium Sorbate, Simethicone, Squalane, Tocopheryl Acetate (D-alpha), Trisodium Ethylenediamine Disuccinate, Tropolone, Xanthan Gum
- Other Information
- PRINCIPAL DISPLAY PANEL - 68 mL Tube Box
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INGREDIENTS AND APPEARANCE
MYCHELLE DERMACEUTICALS SUN SHIELD SPF 28 UNSCENTED PROTECT
zinc oxide and titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72805-061 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Zinc Oxide (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) Zinc Oxide 11.6 g in 100 mL Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide 0.67 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) 1,2-Hexanediol (UNII: TR046Y3K1G) Allantoin (UNII: 344S277G0Z) ALOE VERA LEAF (UNII: ZY81Z83H0X) ALUMINUM OXIDE (UNII: LMI26O6933) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) Caprylyl Glycol (UNII: 00YIU5438U) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) Cetearyl Glucoside (UNII: 09FUA47KNA) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H) Dicaprylyl Ether (UNII: 77JZM5516Z) Dimethicone (UNII: 92RU3N3Y1O) Gluconolactone (UNII: WQ29KQ9POT) Glycerin (UNII: PDC6A3C0OX) Glyceryl Isostearate (UNII: HYE7O27HAO) SOYBEAN OIL (UNII: 241ATL177A) Isononyl Isononanoate (UNII: S4V5BS6GCX) Leuconostoc/Radish Root Ferment Filtrate (UNII: D2QHA03458) LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U) LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y) Magnesium Aluminum Silicate (UNII: 6M3P64V0NC) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) Polysorbate 60 (UNII: CAL22UVI4M) POPULUS TREMULOIDES BARK (UNII: 5543O0CEID) Potassium Sorbate (UNII: 1VPU26JZZ4) Silicon Dioxide (UNII: ETJ7Z6XBU4) Squalane (UNII: GW89575KF9) .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) Trisodium Ethylenediamine Disuccinate (UNII: YA22H34H9Q) Tropolone (UNII: 7L6DL16P1T) Xanthan Gum (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72805-061-68 1 in 1 BOX 03/01/2020 1 68 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 03/01/2020 Labeler - French Transit, Ltd. (100044380)