VIBRIANCE SUNSCREEN BROAD SPECTRUM SPF 50- octinoxate, zinc oxide lotion

Vibriance by

Drug Labeling and Warnings

Vibriance by is a Otc medication manufactured, distributed, or labeled by Prime Enterprises. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Octinoxate 7.5%

Zinc Oxide 9%

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 keeo out of the eyes.

Rinse with water to remove.

Stop use and ask a doctor if arash occurs

Kep out of reach of children if product is walloed, get medical help or contact a Poison Control Center right away

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.
• Reapply:
• After 80 minutes of swimming or sweating
• Immediately after towel drying
• 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 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.

Inactive Ingredients

Butylene Glycol, Cyclopentasiloxane, Ethylhexyl Stearate, Ethylhexylglycerin, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Iron Oxides (CI 77491), Iron Oxides (CI 77492), Iron Oxides (CI 77499), Isopropyl Palmitate, Niacinamide, Octyldodecyl Neopentanoate, Oleth-3 Phosphate, PEG-7 Trimethylolpropane Coconut Ether, Phenoxyethanol, Polyisobutene, Sodium Hyaluronate, Tocopheryl Acetate, Triethoxycaprylylsilane, Water

Other information

• Protect this product from excessive heat and direct sun.

Questions or comments?

Distributed by Vibriance: 400 Wes Peachtree St NW STE 4-1042 ATLANTA, GA 30308

(800) 385-3245

Vibriance SHEER ZINC Sunscreen Broad Spectrum SPF 50

INGREDIENTS AND APPEARANCE

VIBRIANCE  SUNSCREEN BROAD SPECTRUM SPF 50
octinoxate, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58443-0297
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	80.475 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	96.57 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
TRIMETHYLOLPROPANE (UNII: 090GDF4HBD)
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)
NIACINAMIDE (UNII: 25X51I8RD4)
OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)

Product Characteristics
Color	white (NUDE)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58443-0297-3	50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	09/23/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	09/23/2019

Labeler - Prime Enterprises (101946028)

Registrant - Prime Enterprises (101946028)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises		101946028	pack(58443-0297) , manufacture(58443-0297) , label(58443-0297) , analysis(58443-0297)