NEOSTRATA SHEER HYDRATION SUNSCREEN BROAD SPECTRUM SPF 40- octinoxate, octisalate, and avobenzone lotion

NeoStrata Sheer Hydration by

Drug Labeling and Warnings

NeoStrata Sheer Hydration 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 (w/w)

Avobenzone 3%, Octinoxate 7.5%, Octisalate 5%

Purpose

Sunscreen

Uses

• Helps prevent sunburn
• Broad Spectrum SPF 40
• 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

• Apply liberally 15 minutes before sun exposure
• Use a water resistant sunscreen if swimming or sweating
• Reapply sunscreen 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 10 a.m. – 2 p.m.
  • Wear long-sleeve shirts, pants, hats, and sunglasses
• Children under 6 months: Ask a doctor

Other information

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

Inactive ingredients

Aqua/Water/Eau, Acetyl Glucosamine, Butyloctyl Salicylate, Cyclopentasiloxane, Dimethicone, C12-15 Alkyl Benzoate, Glycerin, Butylene Glycol, Glyceryl Stearate, Octyldodecyl Neopentanoate, Cetyl Alcohol, PEG-100 Stearate, Cetearyl Alcohol, Vitis Vinifera (Grape) Seed Extract, Melia Azadirachta Leaf Extract, Lecithin, Arctium Lappa Root Extract, DL-Alpha Tocopheryl Acetate, Dimethicone Crosspolymer, Propylene Glycol, PEG-75 Stearate, Steareth-20, Xanthan Gum, Ceteth-20, Ammonium Hydroxide, Carbomer, Disodium EDTA, Caprylyl Glycol, Phenoxyethanol, Chlorphenesin, Sodium Bisulfite.

Questions?

1-800-628-9904

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

NEOSTRATA®

DEFEND

Sheer Hydration
Sunscreen Broad
Spectrum SPF 40

Lotion
DIN 02470535

50 mL/1.7 FL OZ

INGREDIENTS AND APPEARANCE

NEOSTRATA SHEER HYDRATION   SUNSCREEN BROAD SPECTRUM SPF 40
octinoxate, octisalate, and avobenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58414-0020
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
N-ACETYLGLUCOSAMINE (UNII: V956696549)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
GLYCERIN (UNII: PDC6A3C0OX)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
CETYL ALCOHOL (UNII: 936JST6JCN)
PEG-100 STEARATE (UNII: YD01N1999R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
AZADIRACHTA INDICA LEAF (UNII: HKY915780T)
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)
VITIS VINIFERA SEED (UNII: C34U15ICXA)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PEG-75 STEARATE (UNII: OT38R0N74H)
XANTHAN GUM (UNII: TTV12P4NEE)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CETETH-20 (UNII: I835H2IHHX)
STEARETH-20 (UNII: L0Q8IK9E08)
AMMONIA (UNII: 5138Q19F1X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
SODIUM BISULFITE (UNII: TZX5469Z6I)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMER (UNII: RSA9I561OK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58414-0020-1	1 in 1 CARTON	02/01/2019
1		50 mL 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	02/01/2019

Labeler - NeoStrata Company Inc. (605754829)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetic Essence, LLC		032565959	MANUFACTURE(58414-0020)