STRIVECTIN ADVANCED SPF FULL SCREEN VANISHING TINT- zinc oxide 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

ZINC OXIDE 16%

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

Aqua (Water, Eau), Dimethicone, Butyloctyl Salicylate, Glycerin, Diisobutyl Adipate, Glyceryl Stearate, Ethylhexyl Methoxycrylene, PEG-100 Stearate, Fragrance (Parfum), Potassium Cetyl Phosphate, Myristyl Nicotinate, Hydrogenated Palm Glycerides, Cocos Nucifera (Coconut) Oil, VP/Hexadecene Copolymer, Triceteareth-4 Phosphate, Glycine Soja (Soybean) Oil, Brassica Campestris (Rapeseed) Seed Oil, Polysilicone-11, Caprylyl Glycol, Tocopherol, Argania Spinosa (Argan) Kernel Oil, Bis(Cyano Butylacetate) Anthracenediylidene, Butyrospermum Parkii (Shea) Butter, Elaeis Guineensis (Palm) Butter, Triethoxycaprylylsilane, Phenoxyethanol, Polyglyceryl-3 Diisostearate, Quercus Suber Bark Extract, Xanthan Gum, Glycyrrhiza Glabra (Licorice) Root Extract, Hexylene Glycol, Oryza Sativa (Rice) Extract, Oryza Sativa (Rice) Germ Extract, Disodium EDTA, Oak Root Extract, Simmondsia Chinensis (Jojoba) Seed Oil, Althaea Officinalis Root Extract, Oryza Sativa (Rice) Bran Extract, Retinyl Palmitate, 7-Dehydrocholesterol, Ascorbyl Palmitate, Bisabolol, Citric Acid, Curcuma Longa (Turmeric) Root Extract, Limonene, Citral, Linalool, Iron Oxides (CI 77491), Iron Oxides (CI 77492), Iron Oxides (CI 77499)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

STRIVECTIN ADVANCED SPF FULL SCREEN  VANISHING TINT
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76147-233
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	16 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
GLYCERIN (UNII: PDC6A3C0OX)
DIISOBUTYL ADIPATE (UNII: 8OPY05ZY7S)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
MYRISTYL NICOTINATE (UNII: 8QWM6I035C)
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)
COCONUT OIL (UNII: Q9L0O73W7L)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
TRICETEARETH-4 PHOSPHATE (UNII: 69534Y66NO)
SOYBEAN OIL (UNII: 241ATL177A)
CANOLA OIL (UNII: 331KBJ17RK)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TOCOPHEROL (UNII: R0ZB2556P8)
ARGAN OIL (UNII: 4V59G5UW9X)
CYANOMETHYLACETATE (UNII: VM1DZ0X2D6)
SHEA BUTTER (UNII: K49155WL9Y)
ELAEIS GUINEENSIS FRUIT BUTTER (UNII: UYH3R74N56)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
QUERCUS SUBER BARK (UNII: 8R5219271Q)
XANTHAN GUM (UNII: TTV12P4NEE)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
ORYZA SATIVA WHOLE (UNII: 84IVV0906Z)
EDETATE DISODIUM (UNII: 7FLD91C86K)
QUERCUS PETRAEA WHOLE (UNII: 45C533V2SL)
JOJOBA OIL (UNII: 724GKU717M)
ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
7-DEHYDROCHOLESTEROL (UNII: BK1IU07GKF)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
CURCUMA LONGA WHOLE (UNII: W5488JUO8U)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
Citral (UNII: T7EU0O9VPP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76147-233-11	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)