OTC Medication Information: Jafra Long Wear Makeup Broad Spectrum SPF 20 Bronze D2

JAFRA LONG WEAR MAKEUP BROAD SPECTRUM SPF 20 BRONZE D2- octisalate and 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.

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:

LongWare
(click image for full-size original)

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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTISALATE (OCTISALATE) OCTISALATE 30 mg in 1 mL
ZINC OXIDE (ZINC CATION) ZINC CATION 68.2 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
MEDIUM-CHAIN TRIGLYCERIDES
CYCLOMETHICONE
HYDROXYPROPYLCOCOATE PEG-8 DIMETHICONE
PHENYL TRIMETHICONE
ALKYL (C12-15) BENZOATE
DIMETHICONE
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)
DI-PPG-3 MYRISTYL ETHER ADIPATE
CAPRYLYL TRISILOXANE
PEG-10 DIMETHICONE (600 CST)
DISTEARDIMONIUM HECTORITE
PROPANEDIOL
SODIUM CHLORIDE
SQUALANE
BORON NITRIDE
ALOE VERA LEAF
DMDM HYDANTOIN
DEXTRIN PALMITATE (CORN; 20000 MW)
RICE BRAN
ROSEMARY
HELIANTHUS ANNUUS FLOWERING TOP
TOCOPHEROL
.ALPHA.-TOCOPHEROL ACETATE
PEG-4 LAURATE
IODOPROPYNYL BUTYLCARBAMATE
HYALURONATE SODIUM
BUTYLENE GLYCOL
LENTINULA EDODES MYCELIUM
SWEET POTATO
CENTELLA ASIATICA
BIOSACCHARIDE GUM-4
CHONDRUS CRISPUS CARRAGEENAN
TRIETHOXYCAPRYLYLSILANE
TITANIUM DIOXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70956-403-00 1 BOTTLE in 1 BOX contains a BOTTLE
1 30 mL in 1 BOTTLE This package is contained within the BOX (70956-403-00)
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 Operations
Absara Cosmetics S.A.P.I DE C.V. 816161236 manufacture (70956-403)

Revised: 01/2021 Absara Cosmetics S.A.P.I DE C.V.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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