STRIVECTIN ADVANCED SPF FULL SCREEN ILLUMINATING- 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 7.0%
Octisalate 4.5%
Octocrylene 10%

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

• 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

Aqua (Water, Eau), Glycerin, Butyloctyl Salicylate, Mica, Dimethicone, Titanium Dioxide, Diisobutyl Adipate, Polymethylsilsesquioxane/Silica Crosspolymer, Acrylates/Dimethicone Copolymer, Fragrance (Parfum), Myristyl Nicotinate, Argania Spinosa (Argan) Kernel Oil, Cocos Nucifera (Coconut) Oil, Ethylhexyl Olivate, Glycine Soja (Soybean) Oil, Brassica Campestris (Rapeseed) Seed Oil, Polysilicone-11, Caprylyl Glycol, Tocopherol, Bis(Cyano Butylacetate) Anthracenediylidene, Sodium Acrylates Copolymer, Phenoxyethanol, Polyglyceryl-3 Diisostearate, Quercus Suber Bark Extract, Polyglyceryl-4 Olivate, Glycyrrhiza Glabra (Licorice) Root Extract, Hexylene Glycol, Oryza Sativa (Rice) Extract, Oryza Sativa (Rice) Germ Extract, Disodium EDTA, Oak Root Extract, Althaea Officinalis Root Extract, Oryza Sativa (Rice) Bran Extract, Retinyl Palmitate, 7-Dehydrocholesterol, Ascorbyl Palmitate, Limonene, Citral, Linalool, Tin Oxide

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

STRIVECTIN ADVANCED SPF FULL SCREEN  ILLUMINATING
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76147-232
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	7 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
MICA (UNII: V8A1AW0880)
DIMETHICONE (UNII: 92RU3N3Y1O)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
DIISOBUTYL ADIPATE (UNII: 8OPY05ZY7S)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MYRISTYL NICOTINATE (UNII: 8QWM6I035C)
ARGAN OIL (UNII: 4V59G5UW9X)
COCONUT OIL (UNII: Q9L0O73W7L)
ETHYLHEXYL OLEATE (UNII: R34927QY59)
SOYBEAN OIL (UNII: 241ATL177A)
CANOLA OIL (UNII: 331KBJ17RK)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TOCOPHEROL (UNII: R0ZB2556P8)
BUTYL ACETATE (UNII: 464P5N1905)
SODIUM ACRYLATE (UNII: 7C98FKB43H)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
QUERCUS SUBER BARK (UNII: 8R5219271Q)
POLYGLYCERYL-4 OLEATE (UNII: 15B05TY4GX)
LICORICE (UNII: 61ZBX54883)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
ORYZA SATIVA WHOLE (UNII: 84IVV0906Z)
EDETATE DISODIUM (UNII: 7FLD91C86K)
QUERCUS SPP. WHOLE (UNII: MF4E5I2OUQ)
ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
7-DEHYDROCHOLESTEROL (UNII: BK1IU07GKF)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
CITRAL (UNII: T7EU0O9VPP)
LINALOOL, (+)- (UNII: F4VNO44C09)
STANNIC OXIDE (UNII: KM7N50LOS6)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76147-232-11	1 in 1 BOX	12/04/2019
1		44 mL 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	12/04/2019

Labeler - StriVectin Operating Company, Inc. (832343722)

Registrant - StriVectin Operating Company, Inc. (832343722)