JAFRA LONG WEAR MAKEUP BROAD SPECTRUM SPF 20 FAIR L2

JAFRA LONG WEAR MAKEUP BROAD SPECTRUM SPF 20 FAIR L2 by

Drug Labeling and Warnings

JAFRA LONG WEAR MAKEUP BROAD SPECTRUM SPF 20 FAIR L2 by is a Otc medication manufactured, distributed, or labeled by Absara Cosmetics S.A.P.I DE C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

JAFRA LONG WEAR MAKEUP BROAD SPECTRUM SPF 20 FAIR L2- octisalate, zinc oxide emulsion 
Absara Cosmetics S.A.P.I DE C.V.

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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JAFRA LONG WEAR MAKEUP BROAD SPECTRUM SPF 20 FAIR L2

Drug Facts

Active ingredients

Octinoxate 3%

Zinc Oxide 6.8%

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 product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply liberally 15 minutes before use exposure
• use a water resistant sunscreen if swimming or sweating
• reapply 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-sleeve shirts, pants, hats, and sunglasses

Inactive ingredients

Water/ Aqua, Caprylic Capric Triglyceride, Polyhydroxystearic Acid, Cyclomethicone, Hydroxypropylcocoate PEG-8 Dimethicone, Phenyl Trimethicone, C12-15 Alkyl Benzoate, Dimethiconem Dimethicone Crosspolymer, Caprylic/Carpic Triglyceride, Phenyl Dimethicone, Di-PPG-3 Myristyl Ether Adipate, Caprylyl Methicone, PEG-10 Dimethicone, Disteardimonium Hectorite, Propanediol, Sodium Chloride, Squalane, Boron Nitride, Synthetic Fluorophlogopite, Aloe Barbadensis Leaf Juice, DMDM Hydantoin, Dextrin Palmitate, Oryza Sativa (Rice) Bran Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Tocopherol, Tocopheryl Acetate, PEG-4 Laurate, Iodopropynyl Butylcarbamate, Sodium Hyaluronate, Butylene Glycol, Glycyrrhiza Glabra (Licoride) Extract, Benzimidazole Diamond Amidoethyl  Urea Carbamoyl Propyl Polymethyl Silsesquioxane, Lentinus Edodes (Shiitake) Extract, Ipomoea Batatas Tuber Extract, Centella Asiatica Extract, Withania Somnifera Extract, Butylene Glycol, Biosaccharide Gum-4 Smithsonite Extract, Chondrus Crispus (Carrageenan) Extract, Triethoxycaprylysilane [May Contain +/-: Titanium Dioxide, Iron Oxides/ CI 77492/ CI 77491/ CI 77499]

Other information

protect this product from excessive heat and direct sun

Package Labeling:

JAFRA LONG WEAR MAKEUP BROAD SPECTRUM SPF 20 FAIR L2 
octisalate, zinc oxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70956-225
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	3 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	6.82 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
DI-PPG-3 MYRISTYL ETHER ADIPATE (UNII: T32481VTXW)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
PROPANEDIOL (UNII: 5965N8W85T)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SQUALANE (UNII: GW89575KF9)
BORON NITRIDE (UNII: 2U4T60A6YD)
ORYZA SATIVA WHOLE (UNII: 84IVV0906Z)
TOCOPHEROL (UNII: R0ZB2556P8)
PEG-4 LAURATE (UNII: AYF4VM3N1Z)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
IPOMOEA BATATAS WHOLE (UNII: 46B7278T57)
CENTELLA ASIATICA (UNII: 7M867G6T1U)
WITHANIA SOMNIFERA WHOLE (UNII: GD1Z9GY1FW)
BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90)
CHONDRUS CRISPUS (UNII: OQS23HUA1X)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
WATER (UNII: 059QF0KO0R)
CAPRYLIC/CAPRIC/LINOLEIC TRIGLYCERIDE (UNII: U73D397055)
POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE)
HYDROXYPROPYLCOCOATE PEG-8 DIMETHICONE (UNII: 8TE0BZU36S)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70956-225-01	1 in 1 BOX	09/26/2016	01/18/2022
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	09/26/2016	01/18/2022

Labeler - Absara Cosmetics S.A.P.I DE C.V. (816161236)

Revised: 7/2022

Document Id: e45de792-4b2d-05e3-e053-2a95a90afbc3

34390-5

Set id: 683a0e58-1fec-4690-b334-a6af79c940bb

Version: 3

Effective Time: 20220722