Label: PERFECT SUNSCREEN SPF 50 SHEER MINERAL- zinc oxide lotion
- NDC Code(s): 72203-016-01
- Packager: Bluemercury, Inc.
- 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 March 17, 2022
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
-
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 15 minutes before sun exposure.
- Reapply at least every 2 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 of 15 or higher and other sun protection measures including:
- Limit time in the sun, especially from 10am-2pm.
- Wear long-sleeve shirts, pants, hats & sunglasses.
- Children under 6 months of age: Ask a doctor.
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Inactive Ingredients
Water, Caprylic/Capric Triglyceride, Squalane, Isoamyl Laurate, Butyloctyl Salicylate, Glycerin, Jojoba Esters, Methylpropanediol, Cetyl Alcohol, Glyceryl Stearate, Silica, Tocopherol, Tocopheryl Acetate, Camellia Sinensis Leaf Extract, Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract, Lavandula Angustifolia (Lavender) Flower Extract, Helianthus Annuus (Sunflower) Seed Oil, Pyrus Malus (Apple) Fruit Extract, Allantoin, Bisabolol, Rutin, Lecithin, Hydrogenated Lecithin, Lysolecithin, Caprylyl Glycol, Sclerotium Gum, Iron Oxides, Phenylpropanol, Pullulan, Xanthan Gum, C12-15 Alkyl Benzoate, Polyglyceryl-4 Diisostearate/Polyhydroxystearat e/Sebacate, Polyglyceryl-2 Dipolyhydroxystearate, Ceteth-20, Steareth-20, Tetrasodium Glutamate Diacetate, Phenoxyethanol, PEG-75 Stearate, Ethylhexylglycerin, Hexylene Glycol, Sodium Hydroxide
- Other Information
- Questions?
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PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton
m-61®
powerful skincarePerfect
Sunscreen
SPF 50Tinted Mineral
BROAD SPECTRUM SPF 50
VITAMIN E AND GREEN TEA
TINTED REEF SAFE MINERAL
SUNSCREENTinted mineral SPF 50 with
vitamin E, green tea, lavender
and plant-derived squalaneall skin types
100% paraben-free
100% synthetic fragrance-free
dermatologist tested
allergy tested50 mL/ 1.7 FL. OZ.
-
INGREDIENTS AND APPEARANCE
PERFECT SUNSCREEN SPF 50 SHEER MINERAL
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72203-016 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 0.12 g in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Medium-chain Triglycerides (UNII: C9H2L21V7U) Squalane (UNII: GW89575KF9) Isoamyl Laurate (UNII: M1SLX00M3M) Butyloctyl Salicylate (UNII: 2EH13UN8D3) Glycerin (UNII: PDC6A3C0OX) Methylpropanediol (UNII: N8F53B3R4R) Cetyl Alcohol (UNII: 936JST6JCN) Glyceryl Monostearate (UNII: 230OU9XXE4) Silicon Dioxide (UNII: ETJ7Z6XBU4) Tocopherol (UNII: R0ZB2556P8) .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) Green Tea Leaf (UNII: W2ZU1RY8B0) Lavandula Angustifolia Subsp. Angustifolia Flowering Top (UNII: 9YT4B71U8P) Lavandula Angustifolia Subsp. Angustifolia Flower (UNII: 19AH1RAF4M) Sunflower Oil (UNII: 3W1JG795YI) Apple (UNII: B423VGH5S9) Allantoin (UNII: 344S277G0Z) Levomenol (UNII: 24WE03BX2T) Rutin (UNII: 5G06TVY3R7) Caprylyl Glycol (UNII: 00YIU5438U) Betasizofiran (UNII: 2X51AD1X3T) Ferric Oxide Red (UNII: 1K09F3G675) Phenylpropanol (UNII: 0F897O3O4M) Pullulan (UNII: 8ZQ0AYU1TT) Xanthan Gum (UNII: TTV12P4NEE) Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ) Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate (UNII: 687U3PEB2Y) Polyglyceryl-2 Dipolyhydroxystearate (UNII: 9229XJ4V12) Ceteth-20 (UNII: I835H2IHHX) Steareth-20 (UNII: L0Q8IK9E08) Tetrasodium Glutamate Diacetate (UNII: 5EHL50I4MY) Phenoxyethanol (UNII: HIE492ZZ3T) PEG-75 Stearate (UNII: OT38R0N74H) Ethylhexylglycerin (UNII: 147D247K3P) Hexylene Glycol (UNII: KEH0A3F75J) Sodium Hydroxide (UNII: 55X04QC32I) Product Characteristics Color BROWN Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72203-016-01 1 in 1 CARTON 04/15/2022 1 50 mL in 1 BOTTLE; 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 04/15/2022 Labeler - Bluemercury, Inc. (097435361) Establishment Name Address ID/FEI Business Operations Nanophase Technologies 623502044 MANUFACTURE(72203-016)