Label: PAULAS CHOICE ON-THE-GO SHIELDING POWDER BROAD SPECTRUM SPF 30- zinc oxide powder
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Contains inactivated NDC Code(s)
NDC Code(s): 76144-237-00, 76144-237-04 - Packager: Paula's Choice, LLC.
- 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 June 8, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
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INSTRUCTIONS FOR USE
- Apply liberally 15 minutes before sun exposure.
- Use a water-resistant sunscreen if swimming or sweating:
- Immediately after towel drying.
- At least every two hours.
Remove cap. On first use remove plastic plug from center of brush and discard. Sweep brush over face, neck, and décolletage to release powder. Magnetic brush head can be removed for cleaning.
- DOSAGE & ADMINISTRATION
- INDICATIONS & USAGE
- WARNINGS
- ASK DOCTOR/PHARMACIST
- KEEP OUT OF REACH OF CHILDREN
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INACTIVE INGREDIENT
Synthetic Fluorphlogopite, Boron Nitride, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Silica, Oryza Sativa (Rice) Bran Starch, Butylene Glycol, Stearic Acid, Ceramide NP, Tocopherol, Olive Glycerides, Ascorbyl Palmitate, Salix Nigra (Willow) Bark Extract, Water (Aqua), Triethoxycaprylylsilane, Polymethylsilsesquioxane, Nylon-6/12, EDTA, Retinyl Palmitate, Potassium Sorbate, Chlorphenesin, Iron Oxides (CI 77491, CI 77492, CI 77499).
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OTHER SAFETY INFORMATION
Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this reis, regularly use a sunscree with a broad spectrum SPF or 15 or higher and other sun preotectin measures, including:
- Limit time in the sun, especially from 10AM-2PM.
- Wear long-sleeve shirts, pants, hats and sunglasses.
Other information
Protect the product in this container from excessive heat and direct sun. Store at 20-25C (68-77F).
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PAULAS CHOICE ON-THE-GO SHIELDING POWDER BROAD SPECTRUM SPF 30
zinc oxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76144-237 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 192 mg in 1 mL Inactive Ingredients Ingredient Name Strength FERRIC OXIDE RED (UNII: 1K09F3G675) ASCORBYL PALMITATE (UNII: QN83US2B0N) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ORYZA SATIVA WHOLE (UNII: 84IVV0906Z) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) WATER (UNII: 059QF0KO0R) SALIX NIGRA BARK (UNII: QU52J3A5B3) EDETIC ACID (UNII: 9G34HU7RV0) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) BORON NITRIDE (UNII: 2U4T60A6YD) VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) NYLON 612 CYCLIC DIMER (UNII: Q1D37SUG0G) FERROSOFERRIC OXIDE (UNII: XM0M87F357) CHLORPHENESIN (UNII: I670DAL4SZ) OLIVE OIL (UNII: 6UYK2W1W1E) TOCOPHEROL (UNII: R0ZB2556P8) CERAMIDE NP (UNII: 4370DF050B) STEARIC ACID (UNII: 4ELV7Z65AP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76144-237-04 1 in 1 CARTON 03/12/2019 1 NDC:76144-237-00 4.48 mL in 1 CONTAINER; 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 03/12/2019 Labeler - Paula's Choice, LLC. (029583981)
