Label: TARTEGUARD MINERAL POWDER SPF 30- titanium dioxide and zinc oxide liquid
-
Contains inactivated NDC Code(s)
NDC Code(s): 51060-126-01 - Packager: Tarte, Inc
- 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 March 26, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- 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
-
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.
-
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
-
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
-
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)
