Label: LINEA JOSE IGNACIO FOR FACE SUNSCREEN BROAD SPECTRUM SPF 30- sunscreen broad spectrum spf 30 lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 69096-8001-1, 69096-8001-2 - 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 September 1, 2018
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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Linea Jose Ignacio For Face Sunscreen Broad Spectrum SPF 30
Drug Facts
Active Ingredients
Homosalate 10.00%
Ethylhexyl methoxycinnamate 7.50%
Benzophenone-3 6.00%
Ethylhexyl salicylate 5.00%
Butyl methoxydibenzoyl methane 3.00%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.
- Contains benzophnone-3.
- 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.
* During long sun exposure.
- Ask a doctor for children under 6 months.
- This product has no protection against sunburn.
- If the quantity applied is not adequate, the level of protection will be reduced.
- Avoid prolonged exposure of children to the sun.
- Sun Protection Measures: Spending time in the sun increases you 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
Water/Aqua/Eau, Aloe Barbadensis Leaf Juice, Propylene Glycol, Caprylic/Capric Triglyceride, Glyceryl Stearate, PEG-100 Stearate, Stearic Acid, C12-15 Alkyl Benzoate, Dimethicone, Caprylyl Glycol, Carbomer, Triethanolamine, Citrus Limon (Lemon) Peel Extract, Glycerin, Limonene, Allantoin, Caprylhydroxamic Acid, Cetyl Alcohol, Panthenol (Pro Vitamin B5), Zingiber Officinale (Ginger) Root Extract, Lycium Barbarum (Goji Berry) Fruit Extract, Punica Granatum (Pomegranate) Extract, Aspalathus Linearis (Red Tea) Leaf Extract, Camellia Sinensis (Green and White Tea) Leaf Extract, Vitis Vinifera (Grape) Seed Extract
Other Information
Protect this product from excessive heat and direct sun
Questions or comments
www.lineajoseignacio.com
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INGREDIENTS AND APPEARANCE
LINEA JOSE IGNACIO FOR FACE SUNSCREEN BROAD SPECTRUM SPF 30
sunscreen broad spectrum spf 30 lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69096-8001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 5.3032 g in 88.3872 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 6.629 g in 88.3872 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2.6516 g in 88.3872 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 8.8387 g in 88.3872 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.4193 g in 88.3872 g Inactive Ingredients Ingredient Name Strength CARBOMER 940 (UNII: 4Q93RCW27E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) VITIS VINIFERA SEED (UNII: C34U15ICXA) PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D) LEMON PEEL (UNII: 72O054U628) LYCIUM BARBARUM ROOT BARK (UNII: 766SVR5GCU) DIMETHICONE (UNII: 92RU3N3Y1O) CETYL ALCOHOL (UNII: 936JST6JCN) TROLAMINE (UNII: 9O3K93S3TK) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) ASPALATHUS LINEARIS LEAF (UNII: H7UGK1GJCU) PEG-100 STEARATE (UNII: YD01N1999R) CAPRYLYL GLYCOL (UNII: 00YIU5438U) STEARIC ACID (UNII: 4ELV7Z65AP) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) GLYCERIN (UNII: PDC6A3C0OX) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) GREEN TEA LEAF (UNII: W2ZU1RY8B0) PANTHENOL (UNII: WV9CM0O67Z) WATER (UNII: 059QF0KO0R) ALOE VERA LEAF (UNII: ZY81Z83H0X) LIMONENE, (+)- (UNII: GFD7C86Q1W) ALLANTOIN (UNII: 344S277G0Z) ZINGIBER OFFICINALE WHOLE (UNII: IN6Q3S3414) Product Characteristics Color Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69096-8001-1 88.3872 g in 1 CARTON; Type 0: Not a Combination Product 10/01/2018 2 NDC:69096-8001-2 88.3872 g in 1 TUBE; 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) Establishment Name Address ID/FEI Business Operations June Jacobs Labs LLC 082439410 manufacture(69096-8001)