Label: MYCHELLE DERMACEUTICALS SUN SHIELD SPF 50 NON-TINTED PROTECT- zinc oxide stick
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Contains inactivated NDC Code(s)
NDC Code(s): 72805-101-15 - 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 7, 2022
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
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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
- Apply liberally and evenly 15 minutes before sun exposure.
- Reapply:
- After 80 minutes of swimming or sweating.
- Immediately after towel drying
- 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
Beeswax, Bisabolol, Butyrospermum Parkii (Shea Butter), Calophyllum Tacamahaca Seed Oil, Cannabis Sativa Seed Oil, Euphorbia Cerifera (Candelilla) Wax, Jojoba Esters, Octyldodecyl Olivate, Oryza Sativa (Rice) Bran Oil, Oryzanol, Persea Gratissima (Avocado) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Theobroma Cacao (Cocoa) Seed Butter, Tocopherol
- Other Information
- PRINCIPAL DISPLAY PANEL - 15 g Container Box
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INGREDIENTS AND APPEARANCE
MYCHELLE DERMACEUTICALS SUN SHIELD SPF 50 NON-TINTED PROTECT
zinc oxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72805-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 17 g in 100 g Inactive Ingredients Ingredient Name Strength YELLOW WAX (UNII: 2ZA36H0S2V) LEVOMENOL (UNII: 24WE03BX2T) SHEA BUTTER (UNII: K49155WL9Y) Calophyllum Tacamahaca Seed Oil (UNII: 05G85L61OE) Cannabis Sativa Seed Oil (UNII: 69VJ1LPN1S) CANDELILLA WAX (UNII: WL0328HX19) HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58) RICE BRAN OIL (UNII: LZO6K1506A) Oryzanol (UNII: SST9XCL51M) AVOCADO OIL (UNII: 6VNO72PFC1) JOJOBA OIL (UNII: 724GKU717M) COCOA BUTTER (UNII: 512OYT1CRR) Tocopherol (UNII: R0ZB2556P8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72805-101-15 1 in 1 BOX 03/01/2020 1 15 g in 1 CONTAINER; 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)
