Label: MOISTURIZER SPF 15- titanium dioxide and zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 55789-3106-1 - Packager: Mineral Fusion Natural Brands
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 August 21, 2015
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- 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
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Reapply:
- after 40 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours
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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 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-sleeve shirts, pants, hats, and sunglasses
- children under 6 months: Ask a doctor
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Inactive ingredients
Mineral Water (Aqua), Aloe Barbadensis Leaf (Aloe Vera Gel) Juice1, Vegetable Glycerin, Caprylic/Capric Triglyceride, Zemea (Corn) Propanediol, Cetearyl Alcohol, Cetearyl Glucoside, Lecithin, Cetearyl Olivate, Sorbitan Olivate, Beeswax, Cocamidopropyl Betaine, Xanthan Gum, Palmitoyl Tripeptide-5, Calendula Officinalis Extract1, Camellia Sinensis (White Tea) Extract1, Chamomilla Recutita (Chamomile) Extract1, Kaolin, Citrus Grandis (Grapefruit) Seed Extract, Cucumis Sativus (Cucumber) Fruit Extract1, Gingko Biloba Extract, Gluconolactone, Glycrrhiza Glabra (Licorice) Extract, Isopropyl Palmitate, Isostearyl Palmitate, Tocopherol (Vitamin E), Sodium Benzoate, Natural Fragrance.
- 1
- Certified Organic
- Questions
- PRINCIPAL DISPLAY PANEL - 96 g Tube Carton
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INGREDIENTS AND APPEARANCE
MOISTURIZER SPF 15
titanium dioxide and zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55789-3106 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 3.36 g in 96 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 3.36 g in 96 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) 67.2 g in 96 g ALOE VERA LEAF (UNII: ZY81Z83H0X) GLYCERIN (UNII: PDC6A3C0OX) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) PROPANEDIOL (UNII: 5965N8W85T) CETEARYL OLIVATE (UNII: 58B69Q84JO) SORBITAN OLIVATE (UNII: MDL271E3GR) YELLOW WAX (UNII: 2ZA36H0S2V) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) XANTHAN GUM (UNII: TTV12P4NEE) PALMITOYL TRIPEPTIDE-5 (UNII: 2A3916MQHO) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) WHITE TEA (UNII: O0M3396E09) CHAMOMILE (UNII: FGL3685T2X) KAOLIN (UNII: 24H4NWX5CO) CITRUS PARADISI SEED (UNII: 12F08874Y7) CUCUMBER (UNII: YY7C30VXJT) GINKGO (UNII: 19FUJ2C58T) GLUCONOLACTONE (UNII: WQ29KQ9POT) LICORICE (UNII: 61ZBX54883) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) ISOSTEARYL PALMITATE (UNII: 9EHU0R7ER1) TOCOPHEROL (UNII: R0ZB2556P8) SODIUM BENZOATE (UNII: OJ245FE5EU) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55789-3106-1 1 in 1 CARTON 1 96 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 FINAL part352 08/01/2014 Labeler - Mineral Fusion Natural Brands (831770032)
