Label: ACURE MINERAL PROTECTION SUNSCREEN BROAD SPECTRUM SPF 30- titanium dioxide and zinc oxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 54136-030-01 - Packager: Better Planet Brands
- 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 November 27, 2012
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- ACTIVE INGREDIENT
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- Other Information
- Inactive Ingredients
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 28 g Tube Box
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INGREDIENTS AND APPEARANCE
ACURE MINERAL PROTECTION SUNSCREEN BROAD SPECTRUM SPF 30
titanium dioxide and zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54136-030 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 9 g in 100 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 3 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CAPRYLIC/CAPRIC MONO/DIGLYCERIDES (UNII: U72Q2I8C85) CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309) HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) BENZYL ALCOHOL (UNII: LKG8494WBH) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) GLYCERIN (UNII: PDC6A3C0OX) OPUNTIA FICUS-INDICA (UNII: 23Z87HTQ6P) ALOE VERA LEAF (UNII: ZY81Z83H0X) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) LEVOMENOL (UNII: 24WE03BX2T) ALUMINUM STEARATE (UNII: U6XF9NP8HM) ALUMINUM OXIDE (UNII: LMI26O6933) ISOSTEARIC ACID (UNII: X33R8U0062) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54136-030-01 1 in 1 BOX 1 28 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 11/25/2012 Labeler - Better Planet Brands (960253719)