Label: BRONZING MINERAL BEAUTY BALM SPF 15- titanium dioxide and zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 55789-2403-1 - Packager: Mineral Fusion Natural 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 August 28, 2015
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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 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.
- Children under 6 months: Ask a doctor.
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 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
Aqua, Polysorbate 20, Cetyl Alcohol, Stearyl Alcohol, Tocopherol, Dimethicone, Emulsifying Wax, Caprylic/Capric Triglyceride, Glycerin, Hydroxyethylcellulose, Sodium Hydroxide, Alcohol, Coco-caprylate/Caprate, Sodium Alginate, Xanthan Gum, Butyrospermum Parkii (Shea Butter), Aloe Barbadensis (Aloe) Leaf Juice, Palmitoyl Tripeptide-5, Lavandula Angustifolia (Lavender) Flower Extract, Roman Anthemis Nobilis (Chamomile) Flower Extract, Rosa Canina (Rosehip) Oil*, Ginkgo Biloba Extract, Romarinus Officinalis (Rosemary) Leaf Extract, Thymus Vulgaris (Thyme) Extract, Punica Granatum (Pomegranate) Seed Oil, Ascorbic Acid. May Contain: Mica, Red Iron Oxide, Yellow Iron Oxide, Black Iron Oxide.
- Other Information
- Questions or Comments?
- PRINCIPAL DISPLAY PANEL - 60 mL Tube Carton
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INGREDIENTS AND APPEARANCE
BRONZING MINERAL BEAUTY BALM SPF 15
titanium dioxide and zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55789-2403 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 3.6 g in 60 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 2.4 g in 60 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) 42 mL in 60 mL POLYSORBATE 20 (UNII: 7T1F30V5YH) CETYL ALCOHOL (UNII: 936JST6JCN) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) TOCOPHEROL (UNII: R0ZB2556P8) DIMETHICONE (UNII: 92RU3N3Y1O) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) GLYCERIN (UNII: PDC6A3C0OX) HYDROXYETHYL CELLULOSE (3000 MPA.S AT 1%) (UNII: 7Q6P4JN1QT) SODIUM HYDROXIDE (UNII: 55X04QC32I) ALCOHOL (UNII: 3K9958V90M) COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H) SODIUM ALGINATE (UNII: C269C4G2ZQ) XANTHAN GUM (UNII: TTV12P4NEE) SHEA BUTTER (UNII: K49155WL9Y) ALOE VERA LEAF (UNII: ZY81Z83H0X) PALMITOYL TRIPEPTIDE-5 (UNII: 2A3916MQHO) LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M) CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839) ROSA CANINA FLOWER OIL (UNII: DUY7M48I1T) GINKGO (UNII: 19FUJ2C58T) ROSEMARY OIL (UNII: 8LGU7VM393) THYME (UNII: CW657OBU4N) POMEGRANATE SEED OIL (UNII: 0UI45XV0T6) ASCORBIC ACID (UNII: PQ6CK8PD0R) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55789-2403-1 1 in 1 CARTON 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 08/01/2014 Labeler - Mineral Fusion Natural Brands (831770032)