Label: BRUSH ON BLOCK MINERAL SUNSCREEN BROAD SPECTRUM SPF 30- titanium dioxide 15%, zinc oxide 12% cream
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Contains inactivated NDC Code(s)
NDC Code(s): 58274-006-01 - Packager: SPF Ventures, LLC
- 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 October 15, 2015
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- PURPOSE
- INDICATIONS & USAGE
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DOSAGE & ADMINISTRATION
Directions
- apply liberally 15 minutes before sun exposure
- reapply: after 80 minutes of swimming or sweating, immediately after towel drying, and 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 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. and wear long-sleeve shirts, pants, hats, and sunglasses
- children under 6 months: Ask a doctor
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- QUESTIONS
- OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BRUSH ON BLOCK MINERAL SUNSCREEN BROAD SPECTRUM SPF 30
titanium dioxide 15%, zinc oxide 12% creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58274-006 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 15 g in 100 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 12 g in 100 g Inactive Ingredients Ingredient Name Strength ALUMINUM OXIDE (UNII: LMI26O6933) BORON NITRIDE (UNII: 2U4T60A6YD) CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG) GREEN TEA LEAF (UNII: W2ZU1RY8B0) LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y) LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U) FERRIC OXIDE RED (UNII: 1K09F3G675) MICA (UNII: V8A1AW0880) STARCH, RICE (UNII: 4DGK8B7I3S) SAFFLOWER OIL (UNII: 65UEH262IS) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) RICE BRAN (UNII: R60QEP13IC) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58274-006-01 3.4 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 04/19/2013 Labeler - SPF Ventures, LLC (055483891) Establishment Name Address ID/FEI Business Operations Hudson Cosmetics Manufacturing Corp. DBA Paramount Cosmetics 001321058 manufacture(58274-006)