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 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, Ethylhexylglycerin, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Iron Oxides, Isopropyl Palmitate, Niacinamide, Octyl Stearate, 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?

Mafactured for TRACI LYNN BEAUTY, LLC

954.717.448 / www.tracilynnbeauty.com

Traci Lynn Skin Illuminator Sunscreen Broad Spectrum SPF 50

Principal Display Label

TRACI LYNN SKIN ILUMINATOR BROAD SPECTRUM SPF 50
octinoxate, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58443-0295
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)
OXT-101 (UNII: 622325VBYO)
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	brown (Nude)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58443-0295-3	50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	12/18/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	12/18/2018

Labeler - Prime Enterprises (101946028)

Registrant - Prime Enterprises (101946028)

Name	Address	ID/FEI	Business Operations
Establishment
Prime Enterprises		101946028	pack(58443-0295) , manufacture(58443-0295) , label(58443-0295) , analysis(58443-0295)