- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
-
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.
- Optional: apply to all skin exposed to the sun.
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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 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
- Other information
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Inactive ingredients
Polymethylsilsesquioxane, silica, jojoba esters, caprylyl glycol, alumina, sodium dehydroacetate, phenoxyethanol, vanillin, caprylic/capric triglyceride, hexylene glycol, vanilla planifolia fruit extract, aluminum dimyristate, triethoxycaprylylsilane, disodium stearoyl glutamate, iron oxides, mica. OX100FW000041.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 8 g Tube Carton
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INGREDIENTS AND APPEARANCE
TARTEGUARD MINERAL POWDER SPF 30
titanium dioxide and zinc oxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51060-126 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 86 mg in 1 mL Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 100 mg in 1 mL Inactive Ingredients Ingredient Name Strength POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ALUMINUM OXIDE (UNII: LMI26O6933) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) PHENOXYETHANOL (UNII: HIE492ZZ3T) VANILLIN (UNII: CHI530446X) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) HEXYLENE GLYCOL (UNII: KEH0A3F75J) VANILLA (UNII: Q74T35078H) ALUMINUM DIMYRISTATE (UNII: J2KA067N9O) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M) FERRIC OXIDE RED (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51060-126-01 1 in 1 CARTON 03/20/2018 1 8.3 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 03/20/2018 Labeler - Tarte, Inc (027905186)