Label: LINEA JOSE IGNACIO SUNSCREEN BROAD SPECTRUM SPF 30 WITH ZINC- sunscreen broad spectrum sfp 30 with zinc lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 69096-8002-1, 69096-8002-2 - Packager: Linea Jose Ignacio LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated October 1, 2018
If you are a consumer or patient please visit this version.
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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
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INGREDIENTS AND APPEARANCE
LINEA JOSE IGNACIO SUNSCREEN BROAD SPECTRUM SPF 30 WITH ZINC
sunscreen broad spectrum sfp 30 with zinc lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69096-8002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 30 g in 150 g Inactive Ingredients Ingredient Name Strength 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 Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69096-8002-1 150 g in 1 TUBE; Type 0: Not a Combination Product 10/01/2018 2 NDC:69096-8002-2 150 g in 1 CARTON; Type 0: Not a Combination Product 10/01/2018 
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 10/01/2018 Labeler - Linea Jose Ignacio LLC (079449420)