JAFRA LONG WEAR MAKEUP BROAD SPECTRUM SPF 20 BRONZE D2- octisalate, zinc oxide emulsion

Jafra Long Wear Makeup Broad Spectrum SPF 20 Bronze D2 by

Drug Labeling and Warnings

Jafra Long Wear Makeup Broad Spectrum SPF 20 Bronze D2 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]

Drug Facts

Active ingredients

Octisalate 3%

Zinc Oxide 6.82%

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 externel 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 sun 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 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, Dimethicone, Dimethicone Crosspolymer, Caprylic/Capric Triglyceride, Phenyl Dimethicone, Di-PPG-3 Myristyl Ether Adipate, Caprylyl Methicone, PEG-10 Dimethicone, Disteardimonium Hectorite, Propanediol, Sodium Chloride, Squalane, Boron Nitride, Synthetic Fluorophlogoplte, Aloe Barbadensis Leaf Juice, DMDM Hydantoin, Dextrin Palmitate, Oryza Sativa (Rice) Bran Extract, Rosmarinus Officinalis (Rosemary)Leaf Extract, Helianthus Anuus (Sunflower) Extract, Tocopherol, Tocopheryl Acetate, PEG-4 Laurate, Iodopropyl Butylcarbamate, Sodium Hyaluronate, Butylene Glycol, Glycyrrhiza Glabra (Licorice) Extract, Benzimidazole Diamond Amidoethyl Urea Carbamoyl Propyl Polymethylsllsesquioxane, Lentinu Edodes (Shiitake) Extract, Ipomoea Batatas Tuber Extract, Centella Asiatica Extract, Withanla Somnlferia Extract Butylene Glycol, Biosaccharide Gum-4, Smithsonite Extract, Chondrius Crispus (Carrageenan) Extract, Triethoxycaprylylsiliane[May Contain+/-:Titanium Dioxide, Iron Oxides/ CI 77492/ CI77491/CI 77499]

Other information

• Protect this product from excessive heat and direct sun

Package Labeling:

INGREDIENTS AND APPEARANCE

JAFRA LONG WEAR MAKEUP BROAD SPECTRUM SPF 20 BRONZE D2 
octisalate, zinc oxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70956-403
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	30 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	68.2 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CYCLOMETHICONE (UNII: NMQ347994Z)
HYDROXYPROPYLCOCOATE PEG-8 DIMETHICONE (UNII: 8TE0BZU36S)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
DI-PPG-3 MYRISTYL ETHER ADIPATE (UNII: T32481VTXW)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
PROPANEDIOL (UNII: 5965N8W85T)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SQUALANE (UNII: GW89575KF9)
BORON NITRIDE (UNII: 2U4T60A6YD)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
DMDM HYDANTOIN (UNII: BYR0546TOW)
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)
RICE BRAN (UNII: R60QEP13IC)
ROSEMARY (UNII: IJ67X351P9)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
TOCOPHEROL (UNII: R0ZB2556P8)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PEG-4 LAURATE (UNII: AYF4VM3N1Z)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
LENTINULA EDODES MYCELIUM (UNII: CU2S39TB8O)
SWEET POTATO (UNII: M9WGG9Z9GK)
CENTELLA ASIATICA (UNII: 7M867G6T1U)
BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90)
CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70956-403-00	1 in 1 BOX	11/29/2016
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	11/29/2016

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

Establishment
Name	Address	ID/FEI	Business Operations
Absara Cosmetics S.A.P.I DE C.V.		816161236	manufacture(70956-403)