LINEA JOSE IGNACIO SUNSCREEN BROAD SPECTRUM SPF 30 WITH ZINC- sunscreen broad spectrum sfp 30 with zinc lotion 
Linea Jose Ignacio LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Broad Spectrum Sunscreen SFP 30 with Zinc
Water Resistant (80 Minutes)

Broad Spectrum Sunscreen SFP 30 with Zinc
Water Resistant (80 Minutes)

Drug Facts

Active Ingredients Purpose

Sunscreen

Zinc Oxide 20%

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

Purified Water, Aloe Barbadensis Leaf Juice, Capric Caprylic Triglycerides,

Sorbitan Sesquioleate, Polyglyceryl-4 Isostearate, Hexyl Laurate, Cetyl Dimethicone, Hydrogenated Castor Oil, Magnesium Sulfate (Epsom Salt), Sunflower Oil, Jojoba Oil, Cucumber Extract, Green Tea Extract, Tocopherols (From Soy), Hyaluronic Acid, Phenoxyethanol, Ethyl Hexyl Glycerin

Other information

■ protect this product from excessive heat and direct sun

Manufactured by: Sun Deep Inc. 31285 San Clemente St, Hayward, CA 94544

Made in the USA www.lineajoseignacio.com

SPF 30 zinc Box English

LINEA JOSE IGNACIO SUNSCREEN BROAD SPECTRUM SPF 30 WITH ZINC 
sunscreen broad spectrum sfp 30 with zinc lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69096-8002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE30 g  in 150 g
Inactive Ingredients
Ingredient NameStrength
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAPRIC ACID (UNII: 4G9EDB6V73)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
CETYL DIMETHICONE 150 (UNII: 5L694Y0T22)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
JOJOBA OIL (UNII: 724GKU717M)  
CUCUMBER FRUIT OIL (UNII: R81Y52NPCT)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
TOCOPHEROL (UNII: R0ZB2556P8)  
HYALURONIC ACID (UNII: S270N0TRQY)  
ETHYLHEXYL LAURATE (UNII: 8J6M396U72)  
WATER (UNII: 059QF0KO0R)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69096-8002-1150 g in 1 TUBE; Type 0: Not a Combination Product10/01/2018
2NDC:69096-8002-2150 g in 1 CARTON; Type 0: Not a Combination Product10/01/2018
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35210/01/2018
Labeler - Linea Jose Ignacio LLC (079449420)

Revised: 10/2018
Document Id: 785e3475-ae08-1018-e053-2a91aa0a1d0a
Set id: 785e3475-ae07-1018-e053-2a91aa0a1d0a
Version: 1
Effective Time: 20181001
 
Linea Jose Ignacio LLC