PAULAS CHOICE ON-THE-GO SHIELDING POWDER BROAD SPECTRUM SPF 30- zinc oxide powder

Paulas Choice On-the-Go Shielding Powder Broad Spectrum SPF 30 by

Drug Labeling and Warnings

Paulas Choice On-the-Go Shielding Powder Broad Spectrum SPF 30 by is a Otc medication manufactured, distributed, or labeled by Paula's Choice, LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Zinc Oxide 19.24%

PURPOSE

Sunscreen

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

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.

INDICATIONS & USAGE

• 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.

WARNINGS

For external use only.

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs.

ASK DOCTOR/PHARMACIST

Ask a doctor if rash occurs.

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a Poison Control Center right away.

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).

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

INGREDIENTS AND APPEARANCE

PAULAS CHOICE ON-THE-GO SHIELDING POWDER BROAD SPECTRUM SPF 30 
zinc oxide powder

Product 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)