NEOSTRATA SHEER PHYSICAL PROTECTION SUNSCREEN BROAD SPECTRUM SPF 50- titanium dioxide and zinc oxide lotion

NeoStrata Sheer Physical Protection by

Drug Labeling and Warnings

NeoStrata Sheer Physical Protection by is a Otc medication manufactured, distributed, or labeled by NeoStrata Company Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredients (w/w)

Titanium Dioxide 7%
Zinc Oxide 6%

Purpose

Sunscreen

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

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

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Shake vigorously for 15 seconds before each use
• Apply liberally 15 minutes before sun exposure
• Use a water resistant sunscreen if swimming or sweating
• Reapply sunscreen at least every 2 hours
• Children under 6 months: Ask a doctor
• 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 from 10 a.m. – 2 p.m
  • Wear long-sleeve shirts, pants, hats, and sunglasses

Inactive ingredients

Water, Dimethicone, Isododecane, C12-15 Alkyl Benzoate, Hydrogenated Polydecene, Butyloctyl Salicylate, Gluconolactone, Styrene/Acrylates Copolymer, Alumina, Ammonium Hydroxide, Lactobionic Acid, PEG-9 Polydimethylsiloxyethyl Dimethicone, Phenethyl Benzoate, Nylon-12, DL-Alpha Tocopheryl Acetate, Epigallocatechin Gallate, Polyhydroxystearic Acid, Ethylhexylglycerin, Tocopherol, Dimethicone/PEG-10/15 Crosspolymer, Hydrogen Dimethicone, Isohexadecane, Sodium Citrate, Disteardimonium Hectorite, Magnesium Sulfate, Dipropylene Glycol, Propylene Carbonate, Sodium Bisulfite, Triethoxycaprylylsilane, Phenoxyethanol, Iron Oxides (CI 77492), Iron Oxides (CI 77491), Iron Oxides (CI 77499).

Other information

• Store at 15°C-30°C (59°F-86°F)
• Protect this product from excessive heat and direct sun

Questions?

1-800-628-9904

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PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

NEOSTRATA®

DEFEND

PROTECTION AGAINST
ENVIRONMENTAL STRESSORS

Sheer Physical Protection
Sunscreen Broad Spectrum SPF 50
Matte-finish tinted sunscreen PA++++

50 mL / 1.7 FL OZ

INGREDIENTS AND APPEARANCE

NEOSTRATA SHEER PHYSICAL PROTECTION   SUNSCREEN BROAD SPECTRUM SPF 50
titanium dioxide and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58414-0018
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	70 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	60 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
ISODODECANE (UNII: A8289P68Y2)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
ALUMINUM OXIDE (UNII: LMI26O6933)
AMMONIA (UNII: 5138Q19F1X)
LACTOBIONIC ACID (UNII: 65R938S4DV)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
PHENETHYL BENZOATE (UNII: 0C143929GK)
NYLON-12 (UNII: 446U8J075B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
EPIGALLOCATECHIN GALLATE (UNII: BQM438CTEL)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ISOHEXADECANE (UNII: 918X1OUF1E)
TOCOPHEROL (UNII: R0ZB2556P8)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
METHICONE (20 CST) (UNII: 6777U11MKT)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SODIUM BISULFITE (UNII: TZX5469Z6I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58414-0018-1	1 in 1 CARTON	09/01/2018
1		50 mL in 1 BOTTLE, PLASTIC; 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	09/01/2018

Labeler - NeoStrata Company Inc. (605754829)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetic Essence, LLC.		032565959	MANUFACTURE(58414-0018)