STRIVECTIN-SH NIA-114 UVA UVB SHIELDS SPF 30- homosalate, octisalate, avobenzone, octocrylene, oxybenzone cream

StriVectin-SH NIA-114 UVA UVB Shields SPF 30 by

Drug Labeling and Warnings

StriVectin-SH NIA-114 UVA UVB Shields SPF 30 by is a Otc medication manufactured, distributed, or labeled by StriVectin Operating Company Inc., Englewood Lab, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

PARABEN-FREE, NON-COMEDOGENIC

ARTIFICIAL COLOR AND DYE FREE

Drug Facts

ACTIVE INGREDIENT

Active Ingredients:

Homosalate 7.5%

Octisalate 5%

Avobenzone 3%

Octocrylene 2.6%

Oxybenzone 2%

PURPOSE

Purpose

Sunscreen

INDICATIONS & USAGE

Uses:

• For prevention of sunburn
  

WARNINGS

Warnings:

For external use only. When using this product, keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash or irritation develops and lasts. For children 6 months of age or under, consult a doctor prior to use. Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away. UV exposure from the sun increases the risk of skin cancer, premature skin aging, and other skin damage. It is important to decrease UV exposure by limiting time in the sun, wearing protective clothing, and using a sunscreen.

DOSAGE & ADMINISTRATION

Directions:

• Apply a dime sized amount in the morning on cleansed face and neck or over a moisturizer.
• Reapply as needed or after towel drying, swimming or perspiring.
  

INACTIVE INGREDIENT

Inactive Ingredients:

Water (Aqua/Eau), Myristyl Nicotinate, Glycerin, Dimethicone, Nylon-12 Glycereth-26, Dicaprylyl Carbonate, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Panthenol, Mangifera Indica (Mango) Seed Butter, Lycium Chinense Fruit Extract, Vaccinium Angustifolium (Blueberry) Fruit Extract, Arctostaphylos Uva Ursi Leaf Extract, Bisabolol, Butylene Glycol, Glycine Soja (Soybean) Seed Extract, Ceramide 2, Ceramide 3, Potassium Cetyl Phosphate, Glyceryl Stearate, PEG-100 Stearate, Cetyl Alcohol, PEG-11 Methyl Ether Dimethicone, Sodium Acrylate/Sodium acryloydimethyl Taurate Copolymer, Hydroxyethylcellulose, Caprylyl Glycol, Chlorophenesin, Phenoxyethanol, Disodium EDTA, Potassoium Hydroxide, Hexamethhylinanapyran, Isopropyl  Myristate, Methyldihydrojasmonate 2-Isobutyl-4-Methyltetrahydro-2h-Pyran-4-01, Cucumis Sativus (cucumber)fruit extract, Phenethyl Alcohol, Methyl-A-Ionone, Rosa Damascena Flower Extract, S014

SPL UNCLASSIFIED SECTION

StriVectin Operating Company Inc.

New York, NY 10001

strivectin.com

2011 All Rights Reserved

For U.S. and Canadian consumer inquiries, call 1-877-722-7770.

For all other countries email: customercare@strivectin.com

Manufactured in the U.S.A.

Covered by U.S. Patent

6337065, 6552050, 6464992

Supercharged Age Protection

Sheer Enough For Every Day.

We started with a goal. Protect skin against the aging effects of the sun. So we created a powerful shield against burning UVB rays. Added the highest-rated PA protection (PA+++) against aging UVA rays. Powered up the formula  with antioxidants and out propietary skin-strengthening NIA-114 technology. All in a formula so sheer you can layer it over your StriVectin-SD Intensive Concentrate for Stretch Marks and Wrinkles or moisturizer every day.

PRINCIPAL DISPLAY PANEL

Protects Against Sun Damage

New SPF 30

StriVectin-SH

NIA-114 + UVA/UVB Shields
Age Protect SPF 30

365 Daily Protection

Highest PA protection from aging UVA rays; SPF30 shields against burning UV rays
Long Term Benefit

Born from skin cancer prevention research, NIA-114 strengthens skin barrier to further protect against the signs of aging sun damage.

INGREDIENTS AND APPEARANCE

STRIVECTIN-SH NIA-114 UVA UVB SHIELDS SPF 30 
homosalate, octisalate, avobenzone, octocrylene, oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76147-123
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	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
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	26 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MYRISTYL NICOTINATE (UNII: 8QWM6I035C)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERETH-26 (UNII: NNE56F2N14)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
PANTHENOL (UNII: WV9CM0O67Z)
MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)
LYCIUM CHINENSE FRUIT (UNII: TG711Q7A1Q)
LOWBUSH BLUEBERRY (UNII: G90PX41VP0)
ARCTOSTAPHYLOS UVA-URSI LEAF (UNII: 3M5V3D1X36)
LEVOMENOL (UNII: 24WE03BX2T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SOYBEAN (UNII: L7HT8F1ZOD)
CERAMIDE 2 (UNII: C04977SRJ5)
CERAMIDE 3 (UNII: 4370DF050B)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)
DIMETHYL ETHER (UNII: AM13FS69BX)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ISOHEXADECANE (UNII: 918X1OUF1E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
HEXAMETHYLINDANOPYRAN (UNII: 14170060AT)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
CUCUMBER (UNII: YY7C30VXJT)
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
ROSA DAMASCENA FLOWER (UNII: JWB78P295A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76147-123-01	7 mL in 1 TUBE; Type 0: Not a Combination Product	12/19/2017
2	NDC: 76147-123-02	39 mL in 1 TUBE; Type 0: Not a Combination Product	12/19/2017
3	NDC: 76147-123-03	60 mL in 1 TUBE; Type 0: Not a Combination Product	12/19/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	04/06/2011

Labeler - StriVectin Operating Company Inc. (832343722)

Establishment
Name	Address	ID/FEI	Business Operations
Englewood Lab, Inc.		080366903	manufacture(76147-123)

Establishment
Name	Address	ID/FEI	Business Operations
Englewood Lab Korea Co., Ltd.		690104005	manufacture(76147-123)