NEOSTRATA ULTRA DAYTIME SMOOTHING SPF 20- octinoxate and titanium dioxide cream

NeoStrata Ultra Daytime Smoothing by

Drug Labeling and Warnings

NeoStrata Ultra Daytime Smoothing 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), Glycolic Acid, C12-15 Alkyl Benzoate, Isocetyl Stearate, Glycerin, Glyceryl Stearate, Octyldodecyl Neopentanoate, Hydrogenated Polydecene, PEG-100 Stearate, Ammonium Hydroxide, Citric Acid, Dimethicone, Propylene Glycol, Lactobionic Acid, Cetearyl Alcohol, Arginine, Tocopheryl (Vitamin E) Acetate, Vitis Vinifera (Grape) Seed Extract, Aloe Barbadensis Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Sambucus Nigra Flower Extract, Rosa Centifolia Flower Extract, Calendula Officinalis Flower Extract, Palmitic Acid, Stearic Acid, Myristic Acid, Caprylyl Glycol, Disoidum EDTA, Methicone, Alumina, Polyhydroxystearic Acid, Polysorbate 20, Xanthan Gum, Hydroxyethylcellulose, Chlorphenesin, Phenoxyethanol

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 Bottle Carton

NeoStrata®
RESURFACE

Enhances skin clarity
and texture

Ultra Daytime
Smoothing
Cream

with Sunscreen
Broad Spectrum SPF 20

10 AHA

Net Wt 40 g / 1.4 oz

INGREDIENTS AND APPEARANCE

NEOSTRATA ULTRA DAYTIME SMOOTHING   SPF 20
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58414-3046
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)
GLYCOLIC ACID (UNII: 0WT12SX38S)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ISOCETYL STEARATE (UNII: 3RJ7186O9W)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)
PEG-100 STEARATE (UNII: YD01N1999R)
AMMONIA (UNII: 5138Q19F1X)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DIMETHICONE (UNII: 92RU3N3Y1O)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
LACTOBIONIC ACID (UNII: 65R938S4DV)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
METHICONE (20 CST) (UNII: 6777U11MKT)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ROSA CENTIFOLIA FLOWER (UNII: CS4TE8FF7O)
SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T)
VITIS VINIFERA SEED (UNII: C34U15ICXA)
CHAMOMILE (UNII: FGL3685T2X)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ARGININE (UNII: 94ZLA3W45F)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
PALMITIC ACID (UNII: 2V16EO95H1)
STEARIC ACID (UNII: 4ELV7Z65AP)
MYRISTIC ACID (UNII: 0I3V7S25AW)
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
XANTHAN GUM (UNII: TTV12P4NEE)
ALUMINUM OXIDE (UNII: LMI26O6933)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CHLORPHENESIN (UNII: I670DAL4SZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58414-3046-1	1 in 1 CARTON	07/18/2013	01/31/2021
1		40 g in 1 BOTTLE, PUMP; 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	07/18/2013	01/31/2021

Labeler - NeoStrata Company Inc. (605754829)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetic Essence, LLC.		825646862	MANUFACTURE(58414-3046)