OTC Medication Information: Jafra Sun Tinted Face Protector Sunscreen Broad Spectrum 50

JAFRA SUN TINTED FACE PROTECTOR SUNSCREEN BROAD SPECTRUM 50- avobenzone, octocrylene, homosalate and octisalate cream
Jafra Cosmetics Internationl

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.

Avobenzone 3%…………..Sunscreen

Homosalate 10%………….Sunscreen

Octisalate 5%………………Sunscreen

Octocrylene 10%………….Sunscreen

• 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

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if rash occurs.

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

• 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 a Broad Spectrum SPF value 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

Acrylates/Ammonium Methacrylate Copolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Arginine, Bisabolol, Cellulose Acetate, Cetyl Alcohol, Dicaprylyl Carbonate, Disodium EDTA, Ethylhexylglycerin, Fragrance/Parfum, Glycerin, Glyceryl Stearate, Iron Oxides/CI 77491/CI 77492/CI 77499, Magnesium Stearate, Propylene Glycol Stearate, Panthenol, PEG-100 Stearate, Phenoxyethanol, Polyester-8, Sambucus Nigra (Elderberry) Fruit Extract, Styrene/Acrylates Copolymer, Titanium Dioxide (CI 77891 ), Tocopheryl Acetate, VP/Eicosene Copolymer, Water/Aqua

Protect this product from excessive heat and direct sun

JAFRA

SUN

50+

tinted face protector suncreen broad spectrum SPF 50+

Water Resistant (40 minutes)

50 ml e 1.7 FL OZ (US)

JAFRA SUN TINTED FACE PROTECTOR SUNSCREEN BROAD SPECTRUM 50 avobenzone, homosalate, octisalate, octocrylene cream

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68828-293 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (AVOBENZONE) AVOBENZONE 3 g in 100 mL OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 10 g in 100 mL HOMOSALATE (HOMOSALATE) HOMOSALATE 10 g in 100 mL OCTISALATE (OCTISALATE) OCTISALATE 5 g in 100 mL

Inactive Ingredients Ingredient Name Strength GLYCERYL MONOSTEARATE POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) EUROPEAN ELDERBERRY FERRIC OXIDE RED PEG-100 STEARATE MAGNESIUM STEARATE CELLULOSE ACETATE CETYL ALCOHOL .ALPHA.-TOCOPHEROL ACETATE VINYLPYRROLIDONE/EICOSENE COPOLYMER WATER EDETATE DISODIUM ANHYDROUS GLYCERIN FERRIC OXIDE YELLOW CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) PANTHENOL PHENOXYETHANOL DICAPRYLYL CARBONATE PROPYLENE GLYCOL STEARATE STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) TITANIUM DIOXIDE ARGININE LEVOMENOL ETHYLHEXYLGLYCERIN

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68828-293-01 50 mL in 1 BOTTLE None 2 NDC:68828-293-02 7.5 mL in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 01/14/2021

Labeler — Jafra Cosmetics Internationl (041676479)

Establishment
Name	Address	ID/FEI	Operations
Distribuidora Comercial Jafra, S.A. de C.V.		951612777	manufacture (68828-293)

Revised: 05/2022 Jafra Cosmetics Internationl