Label: PERFECT FINISH SPF-30- zinc oxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 58469-0100-1 - Packager: Jenelt Cosmetics
- 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 April 7, 2015
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
- 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 of age: Ask a doctor.
- Other Information
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Inactive Ingredients
Purified Water, Aloe Barbadensis Leaf Juice, Capric Caprylic Triglycerides, Sorbitan Stearate, Hydrogenated Methyl Abietate, Caster Oil, Polyglycerol-10 Laurate, Magnesium Sulfate (Epsom Salt), Tocopherols, Iron Oxides, Green Tea Extract, Magnesium Ascorbate Phosphate (Vitamin C), L-carnitine, Niacinamide, Phenoxyethanol, Ethyl Hexyl Glycerin
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 60 ml Tube Label
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INGREDIENTS AND APPEARANCE
PERFECT FINISH SPF-30
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58469-0100 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 20 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALOE VERA LEAF (UNII: ZY81Z83H0X) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY) POLYGLYCERYL-10 LAURATE (UNII: MPJ2Q8WI8G) MAGNESIUM SULFATE (UNII: DE08037SAB) Hydrogenated Methyl Abietate (UNII: A23O709X8O) green tea leaf (UNII: W2ZU1RY8B0) MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5) carnitine (UNII: S7UI8SM58A) TOCOPHEROL (UNII: R0ZB2556P8) niacinamide (UNII: 25X51I8RD4) glycerin (UNII: PDC6A3C0OX) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) FERRIC OXIDE RED (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58469-0100-1 60 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 01/20/2014 Labeler - Jenelt Cosmetics (078802794)
