NEOSTRATA DAYTIME PROTECTION SPF 23- octinoxate and titanium dioxide cream

NeoStrata Daytime Protection by

Drug Labeling and Warnings

NeoStrata Daytime Protection by is a Otc medication manufactured, distributed, or labeled by NeoStrata Company Inc., Cosmetic Essence, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Ethylhexyl Methoxycinnamate (Octinoxate) 6.0%
Titanium Dioxide 4.0%

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

Directions

• Apply liberally to face and neck daily, 15 minutes before sun exposure
• Use a water resistant sunscreen if swimming or sweating
• Reapply at least every 2 hours
• 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 10am - 2pm
  • Wear long-sleeved shirts, pants, hats and sunglasses
• Children under 6 months: Ask a doctor

Inactive ingredients

Aqua (Water), Gluconolactone, C12-15 Alkyl Benzoate, Propylene Glycol, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Octyldodecyl Neopentanoate, Lactobionic Acid, Sorbitan Stearate, Isopropyl Palmitate, Tocopheryl (Vitamin E) Acetate, Vitis Vinifera (Grape) Seed Extract, Methicone, Glycerin, Dimethicone, Caprylyl Glycol, Arginine, Ammonium Hydroxide, Glyceryl Stearate, PEG-100 Stearate, Alumina, Sodium Sulfite, Sodium Bisulfite, Polyacrylamide, Polyhydroxystearic Acid, Ethoxydiglycol, Xanthan Gum, Hydroxyethylcellulose, Laureth-7, Disodium EDTA, C13-14 Isoparaffin, Phenoxyethanol, Chlorphenesin.

Other information

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

Questions or comments?

Call toll free 1-800-628-9904 (9am-5pm ET)

PRINCIPAL DISPLAY PANEL - 40 g Tube Carton

NeoStrata®
RESTORE

Powerful antiaging
without irritation

Daytime
Protection
Cream
with Sunscreen
Broad Spectrum SPF 23

10 Bionic/PHA

Net Wt 40 g / 1.4 oz

INGREDIENTS AND APPEARANCE

NEOSTRATA DAYTIME PROTECTION   SPF 23
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58414-3048
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	60 mg  in 1 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	40 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PEG-100 STEARATE (UNII: YD01N1999R)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
DIMETHICONE (UNII: 92RU3N3Y1O)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ARGININE (UNII: 94ZLA3W45F)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
LACTOBIONIC ACID (UNII: 65R938S4DV)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SODIUM SULFITE (UNII: VTK01UQK3G)
SODIUM BISULFITE (UNII: TZX5469Z6I)
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
LAURETH-7 (UNII: Z95S6G8201)
VITIS VINIFERA SEED (UNII: C34U15ICXA)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)
METHICONE (20 CST) (UNII: 6777U11MKT)
ALUMINUM OXIDE (UNII: LMI26O6933)
AMMONIA (UNII: 5138Q19F1X)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
EDETATE DISODIUM (UNII: 7FLD91C86K)
XANTHAN GUM (UNII: TTV12P4NEE)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CHLORPHENESIN (UNII: I670DAL4SZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58414-3048-1	1 in 1 CARTON	08/15/2013	02/28/2021
1		40 g 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	08/15/2013	02/28/2021

Labeler - NeoStrata Company Inc. (605754829)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetic Essence, LLC		825646862	MANUFACTURE(58414-3048)