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FULL PRESCRIBING INFORMATION

Titanium Dioxide 5.0%

Zinc Oxide 5.0%

Sunscreen

  • 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

For external use only.

Do not use on damaged or broken skin.

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

Stop use and ask a doctor if rash occurs.

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

  • pump to dispense product, layer for more coverage
  • apply liberally 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a water resistant sunscreen if swimming or sweating
  • 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 between 10 a.m. and-2p.m.
  • wear long-sleeve shirts, pants, hats and sunglasses
  • children under 6 months: ask as doctor--this product should NOT be used on children of any age

aqua/water/eau, cyclopentasiloxane, octyldodecyl neopentanoate, butylene glycol, glycerin, peg/ppg-18/18 dimethicone, dimethicone, camellia oleifera leaf extract, aluminum hydroxide, stearic acid, boron nitride, lactic acid, sodoim chloride, caprylyl glycol, sodium dehydroacetate, mica, phytantriol, triethoxycaprylylsilane, dextrin palmitate, sodium hyaluronate, lysine, retinyl acetate, tetrahexyldecyl ascorbate, tocopherol, avena sativa (oat) bran extract, magnesuim ascorbyl phosphate, magnesium choloride, potassium chloride, retinyl palmitate, potassium sorbate, hexylene glycol, disodium edta, palmitic acid, sodium benzoate, zinc chloride, phenoxyethanol, may contain: titainium dioxide (ci 77891), zinc oxide (ci 99947), iron oxides (ci 77491, ci 77492, ci 77499).

  • protect this product from excessive heat and direct sun

hope in a jar

Call toll-free 1-800-568-3151 from 6 a.m.-5 p.m. MST (Monday-Friday)

hope in a jar

Titanium Dioxide, zinc oxide CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:50184-1033
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
titanium dioxide 3.35 g
Zinc Oxide Zinc oxide 5.49 g

Inactive Ingredients

Ingredient Name Strength
water
CYCLOMETHICONE 5
OCTYLDODECYL NEOPENTANOATE
BUTYLENE GLYCOL
GLYCERIN
PEG/PPG-18/18 DIMETHICONE
DIMETHICONE
CAMELLIA OLEIFERA LEAF
aluminum hydroxide
STEARIC ACID
BORON NITRIDE
LACTIC ACID
SODIUM CHLORIDE
CAPRYLYL GLYCOL
SODIUM DEHYDROACETATE
MICA
PHYTANTRIOL
TRIETHOXYCAPRYLYLSILANE
HYALURONATE SODIUM
Lysine
VITAMIN A ACETATE
TETRAHEXYLDECYL ASCORBATE
Tocopherol
OAT BRAN
Magnesium Ascorbyl Phosphate
potassium chloride
VITAMIN A PALMITATE
POTASSIUM SORBATE
Hexylene Glycol
EDETATE DISODIUM
PALMITIC ACID
SODIUM BENZOATE
ZINC CHLORIDE
PHENOXYETHANOL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:50184-1033-1 30 in 1 TUBE
2 NDC:50184-1033-2 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2013-05-01


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