STRIVECTIN ADVANCED SPF FULL SCREEN CLEAR FINISH- avobenzone, homosalate, octisalate, octocrylene lotion

StriVectin Advanced SPF Full Screen by

Drug Labeling and Warnings

StriVectin Advanced SPF Full Screen by is a Otc medication manufactured, distributed, or labeled by StriVectin Operating Company, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

Avobenzone 3.0%
Homosalate 9.0%
Octisalate 4.5%
Octocrylene 8.5%

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.

KEEP OUT OF REACH OF CHILDREN

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

DIRECTIONS

• Apply generously 15 minutes before sun exposure and as needed
• reapply at least every 2 hours
• use a water resistant sunscreen if swimming or sweating
• Sun Protection Measures. Spending time inthe sun increases your risk of skin cancer andearly skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPFvalue of 15 or higher and other sun protectionmeasures including:
• limit time in the sun, especially from 10 a.m. - 2 p.m.
• wear long-sleeved shirts, pants, hats,and sunglasses
• children under 6 months of age: ask a doctor

OTHER INFORMATION

Protect the product in this container from excessive heat and direct sun.

INACTIVE INGREDIENTS

Isohexadecane, Dimethicone/Bis-Isobutyl PPG-20 Crosspolymer, Butyloctyl Salicylate, Polyester-8, Polymethylsilsesquioxane/Silica Crosspolymer, Glyceryl Dibehenate, VP/Hexadecene Copolymer, Fragrance (Parfum), Myristyl Nicotinate, Glycine Soja (Soybean) Oil, Tocopherol, Argania Spinosa (Argan) Kernel Oil, Bis(Cyano Butylacetate) Anthracenediylidene, Polyglyceryl-3 Diisostearate, Oryza Sativa (Rice) Extract, Oryza Sativa (Rice) Germ Extract, Cocos Nucifera (Coconut) Oil, Brassica Campestris (Rapeseed) Seed Oil, Quercus Suber Bark Extract, Retinyl Palmitate, Glycyrrhiza Glabra (Licorice) (Licorice) Root Extract, 7-Dehydrocholesterol, Ascorbyl Palmitate, Oak Root Extract, Althaea Officinalis Root Extract, Oryza Sativa (Rice) Bran Extract, Limonene, Citral, Linalool

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

STRIVECTIN ADVANCED SPF FULL SCREEN  CLEAR FINISH
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76147-234
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	9 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	8.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ISOHEXADECANE (UNII: 918X1OUF1E)
DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER (UNII: O4I3UFO6ZF)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
SILICA, TRIMETHYLSILYL CAPPED (UNII: VU10KU4B9S)
GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
MYRISTYL NICOTINATE (UNII: 8QWM6I035C)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
ARGAN OIL (UNII: 4V59G5UW9X)
BUTYL ACETATE (UNII: 464P5N1905)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
ORYZA SATIVA WHOLE (UNII: 84IVV0906Z)
COCONUT OIL (UNII: Q9L0O73W7L)
CANOLA OIL (UNII: 331KBJ17RK)
QUERCUS SUBER BARK (UNII: 8R5219271Q)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
LICORICE (UNII: 61ZBX54883)
7-DEHYDROCHOLESTEROL (UNII: BK1IU07GKF)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
QUERCUS SPP. WHOLE (UNII: MF4E5I2OUQ)
ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
Citral (UNII: T7EU0O9VPP)
LINALOOL, (+)- (UNII: F4VNO44C09)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76147-234-11	1 in 1 BOX	12/04/2019
1		44 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 76147-234-13	1 mL in 1 PACKET; Type 0: Not a Combination Product	12/04/2019
3	NDC: 76147-234-14	7 mL in 1 TUBE; Type 0: Not a Combination Product	12/13/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/04/2019

Labeler - StriVectin Operating Company, Inc. (832343722)

Registrant - StriVectin Operating Company, Inc. (832343722)