LINEA JOSE IGNACIO FOR FACE SUNSCREEN BROAD SPECTRUM SPF 30- sunscreen broad spectrum spf 30 lotion

Linea Jose Ignacio For Face Sunscreen Broad Spectrum SPF 30 by

Drug Labeling and Warnings

Linea Jose Ignacio For Face Sunscreen Broad Spectrum SPF 30 by is a Otc medication manufactured, distributed, or labeled by Linea Jose Ignacio LLC, June Jacobs Labs LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

LINEA JOSE IGNACIO FOR FACE SUNSCREEN BROAD SPECTRUM SPF 30 
sunscreen broad spectrum spf 30 lotion

Product 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)