Label: MINERAL SPF 40 MOISTURIZER- zinc oxide and titanium dioxide lotion
- NDC Code(s): 55789-3109-2
- Packager: Mineral Fusion 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 September 17, 2019
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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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 to clean skin 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 (Aloe Vera) Leaf Juice1 Caprylic/Capric Triglyceride, Ethylhexyl Palmitate, Glyceryl Stearate, Cetyl Dimethicone, Vegetable Glycerin, Hexyl Laurate, Polyglyceryl-4 Isostearate, Cetyl Alcohol, Myristyl Myristate, Simmondsia Chinensis (Jojoba) Seed Oil1 Butyrospermum Parkii (Shea) Butter1, Panthenol, Malachite Extract, Smithsonite Extract, Rhodochrosite Extract, Hematite Extract, Palmitoyl Pentapeptide-3, Cucumis Sativus (Cucumber) Fruit Extract1, Tocopherol Acetate, Allantoin, Soy Lecithin, Camellia Sinensis (Green Tea) Leaf Extract1, Sodium PCA, Hyaluronic Acid, Chamomilla Recutita (Matricaria) Flower Extract1, Rosmarinus Officinalis (Rosemary) Leaf Oil, Calendula Officinalis Flower Extract1, Cedrus Atlantica (Cedarwood) Bark Oil, Ginkgo Biloba Leaf Extract1, Alaria Esculenta (Sea Kelp) Extract, Pelargonium Graveolens (Geranium) Flower Oil, Magnesium Aluminum Silicate, Benzyl Alcohol, Ethylhexylglycerin, Phenoxyethanol, Natural Fragrance.
- 1
- Certified Organic
- Questions
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 96 g Tube Carton
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INGREDIENTS AND APPEARANCE
MINERAL SPF 40 MOISTURIZER
zinc oxide and titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55789-3109 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 5 g in 100 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 7.5 g in 100 mL Inactive Ingredients Ingredient Name Strength ETHYLHEXYL PALMITATE (UNII: 2865993309) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB) GLYCERIN (UNII: PDC6A3C0OX) HEXYL LAURATE (UNII: 4CG9F9W01Q) ALOE VERA LEAF (UNII: ZY81Z83H0X) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CETYL ALCOHOL (UNII: 936JST6JCN) SHEA BUTTER (UNII: K49155WL9Y) PANTHENOL (UNII: WV9CM0O67Z) MAGNESIUM ASPARTATE (UNII: R17X820ROL) ZINC GLUCONATE (UNII: U6WSN5SQ1Z) JOJOBA OIL (UNII: 724GKU717M) TOCOPHEROL (UNII: R0ZB2556P8) COPPER GLUCONATE (UNII: RV823G6G67) HYALURONATE SODIUM (UNII: YSE9PPT4TH) PALMITOYL PENTAPEPTIDE-4 (UNII: KK181SM5JG) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) ALLANTOIN (UNII: 344S277G0Z) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) GREEN TEA LEAF (UNII: W2ZU1RY8B0) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55789-3109-2 1 in 1 CARTON 09/17/2019 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 NOT FINAL part352 12/10/2012 Labeler - Mineral Fusion brands (831770032)