Label: MYCHELLE DERMACEUTICALS REPLENISHING SOLAR DEFENSE SPF 30 PROTECT- zinc oxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 72805-031-77 - 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
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- 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
- 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
Alcohol, Aleurites Moluccanus Seed Oil, Aqua (Water), Behenyl Alcohol, Bisabolol (L-alpha), Candelilla/Jojoba/Rice Bran Polyglyceryl-3 Esters, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Citric Acid, Ergothioneine (L), Ethyl Macadamiate, Glycerin, Glyceryl Isostearate, Glyceryl Stearate, Hamamelis Virginiana (Witch Hazel) Water, Hordeum Distichon (Barley) Extract, Hydrogenated Palm Glycerides, Hydroxypropyl Methylcellulose, Hydroxypropyl Starch Phosphate, Isodecyl Neopentanoate, Lecithin, Lonicera Caprifolium (Honeysuckle) Flower Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Macadamia Ternifolia Seed Oil, Malic Acid (L), Phellodendron Amurense Bark Extract, Phytic Acid, Polyglyceryl-10 Pentastearate, Polyhydroxystearic Acid, Porphyra Umbilicalis (Red Algae) Extract, Potassium Cetyl Phosphate, Santalum Album (Sandalwood) Extract, Sodium Hydroxide, Sodium Lactate, Sodium Stearoyl Lactylate, Tocopherol (D-alpha), Tocopheryl Acetate (D-alpha)
- Other Information
- PRINCIPAL DISPLAY PANEL - 68 mL Tube Box
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INGREDIENTS AND APPEARANCE
MYCHELLE DERMACEUTICALS REPLENISHING SOLAR DEFENSE SPF 30 PROTECT
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72805-031 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 13.5 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Alcohol (UNII: 3K9958V90M) KUKUI NUT OIL (UNII: TP11QR7B8R) DOCOSANOL (UNII: 9G1OE216XY) LEVOMENOL (UNII: 24WE03BX2T) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) ERGOTHIONEINE (UNII: BDZ3DQM98W) Ethyl Macadamiate (UNII: ANA2NCS6V1) Glycerin (UNII: PDC6A3C0OX) Glyceryl Isostearate (UNII: HYE7O27HAO) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V) BARLEY (UNII: 5PWM7YLI7R) Hydrogenated Palm Glycerides (UNII: YCZ8EM144Q) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) HYDROXYPROPYL DISTARCH PHOSPHATE, HIGH AMYLOSE CORN (UNII: 9F8ET54T05) Isodecyl Neopentanoate (UNII: W60VYE24XC) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U) LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y) MACADAMIA OIL (UNII: 515610SU8C) MALIC ACID, L- (UNII: J3TZF807X5) PHELLODENDRON AMURENSE BARK (UNII: PBG27B754G) FYTIC ACID (UNII: 7IGF0S7R8I) Polyglyceryl-10 Pentastearate (UNII: PMX5872701) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) PORPHYRA UMBILICALIS (UNII: 14AN0J70WO) Potassium Cetyl Phosphate (UNII: 03KCY6P7UT) SANDALWOOD (UNII: 3641YW25N2) Sodium Hydroxide (UNII: 55X04QC32I) Sodium Lactate (UNII: TU7HW0W0QT) Sodium Stearoyl Lactylate (UNII: IN99IT31LN) .ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9) .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72805-031-77 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)
