Label: ATTITUDE MINERAL SUNSCREEN SENSITIVE SKIN CARE FAMILY- zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 61649-004-15 - Packager: Bio Spectra
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 July 5, 2018
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- 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 - Reapply: - At least every 2 hours - After 40 minutes of swimming or sweathing - Immediately after towel drying - 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 value of 15 or higher and other sun protection measures including: - Limit time in the sun, especially from 10am–2pm - Wear long-sleeved shirts, pants, hats, and sunglasses - Ask a doctor for use on children under 6 months of age.
- Inactive or non-medicinal ingredients
- Other Information
- PRINCIPAL DISPLAY PANEL - 150 g Tube Label
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INGREDIENTS AND APPEARANCE
ATTITUDE MINERAL SUNSCREEN SENSITIVE SKIN CARE FAMILY
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61649-004 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 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) OATMEAL (UNII: 8PI54V663Y) GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) C10-18 TRIGLYCERIDES (UNII: 43AGM4PHPI) GLYCERIN (UNII: PDC6A3C0OX) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) CAPRYLYL GLYCOL (UNII: 00YIU5438U) XANTHAN GUM (UNII: TTV12P4NEE) SODIUM GLUCONATE (UNII: R6Q3791S76) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61649-004-15 1 in 1 CARTON 02/01/2017 1 150 g 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 NOT FINAL part352 02/01/2017 Labeler - Bio Spectra (201137051) Establishment Name Address ID/FEI Business Operations Fusion Solution inc 251948899 MANUFACTURE(61649-004)
