Label: SPF-30 BB- zinc oxide lotion
- NDC Code(s): 69090-0100-1
- Packager: ZION HEALTH
- Category: HUMAN OTC DRUG LABEL
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 12, 2023
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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 other information) , decreases the risk of skin cancer and early skin aging caused by the sun.
- Warnings
- Directions
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Other Information
Sun Protection Measures
Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with a Broad Spectrum SPF value 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-sleeved shirts, pants, hats and sunglasses.
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Inactive Ingredients
Purified Water, Aloe Barbadensis Leaf Juice, Capric Caprylic, Triglycerides, Sorbitan Sesquioleate, Hydrogenated Castor Oil, Polyglycerol-10 Laurate, Magnesium Sulfate, Tetrahexyldecyl Ascorbate, Palmitoyl Tripeptide-3, Sunflower Oil, Jojoba Oil, Tocopherols, Hyaluronic Acid, Montmorillonite, Malakite Extract, Phenoxyethanol, Ethyl Hexyl Glycerin, Iron Oxides.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 110 mL Tube Label
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INGREDIENTS AND APPEARANCE
SPF-30 BB
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69090-0100 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, UNSPECIFIED FORM (UNII: DE08037SAB) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) SUNFLOWER OIL (UNII: 3W1JG795YI) JOJOBA OIL (UNII: 724GKU717M) TOCOPHEROL (UNII: R0ZB2556P8) HYALURONIC ACID (UNII: S270N0TRQY) MONTMORILLONITE (UNII: A585MN1H2L) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) FERRIC OXIDE RED (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69090-0100-1 110 mL in 1 TUBE; Type 0: Not a Combination Product 01/20/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 01/20/2014 Labeler - ZION HEALTH (044641282)