LINEA JOSE IGNACIO SUNSCREEN BROAD SPECTRUM SPF30- avobenzone, octinoxate, octisalate, and oxybenzone lotion

Linea Jose Ignacio Sunscreen Broad Spectrum SPF30 by

Drug Labeling and Warnings

Linea Jose Ignacio Sunscreen Broad Spectrum SPF30 by is a Otc medication manufactured, distributed, or labeled by Linea Jose Ignacio. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Avobenzone 1.5%
Octinoxate 7.5%
Octisalate 5.0%
Oxybenzone 6.0%

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

Stop use and ask a doctor if rash occurs

When using this product keep out of eyes. Rinse with water to remove.

Keep out of reach of children. If 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
• children under 6 months: Ask a doctor
• 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 a 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 sleeved shirts, pants, hats and sunglasses

Inactive Ingredients

Allantoin, Aloe Barbadensis Leaf Juice, Cetearyl Alcohol, Cetyl Phosphate, Ethylhexyl Glycerin, Glycerin, Glyceryl Stearate, Green Tea Extract, Magnesium Ascorbyl Phosphate, Methyl Gluceth-20, Mixed Tocopherols, Octyl Palmitate, Panthenol, Phenoxyethanol, PVP Eicosene Copolymer, Stearic Acid, Tocopheral Acetate, Water

Other information

• protect this product from excessive heat and direct sun

Questions?

Visit www.lineajoseignacio.com

SPL UNCLASSIFIED SECTION

Dist. by:
Linea Jose Ignacio
53 East 34th Street
Paterson, NJ 07514
www.lineajoseignacio.com

PRINCIPAL DISPLAY PANEL - 150 mL Tube Label

LINEA
JOSE
IGNACIO™

SUNSCREEN

BROAD SPECTRUM
SPF 30

WATER RESISTANT
80 MINUTES

Net Wt. 5 FL OZ (150 mL)

INGREDIENTS AND APPEARANCE

LINEA JOSE IGNACIO SUNSCREEN BROAD SPECTRUM SPF30 
avobenzone, octinoxate, octisalate, and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69096-0100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	15 mg  in 1 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	75 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	50 mg  in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	60 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALLANTOIN (UNII: 344S277G0Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL PHOSPHATE (UNII: VT07D6X67O)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
METHYL GLUCETH-20 (UNII: J3QD0LD11P)
TOCOPHEROL (UNII: R0ZB2556P8)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
PANTHENOL (UNII: WV9CM0O67Z)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
STEARIC ACID (UNII: 4ELV7Z65AP)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69096-0100-1	150 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	12/10/2012

Labeler - Linea Jose Ignacio (079449420)