JAFRA SUN SUNSCREEN BROAD SPECTRUM SPF 50- avobenzone, homosalate, octisalate, octocrylene spray

Jafra Sun sunscreen broad spectrum SPF 50 by

Drug Labeling and Warnings

Jafra Sun sunscreen broad spectrum SPF 50 by is a Otc medication manufactured, distributed, or labeled by Jafra Cosmetics International, Distribuidora Comercial Jafra, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients Purpose

Avobenzone 3% Sunscreen

Homosalate 10% Sunscreen

Octisalate 5% Sunscreen

Octocrylene 10% Sunscreen

PURPOSE

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.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

If product is swallowed, get medical help or contact a poison Control Center right away

INDICATIONS & USAGE

Stop use and ask a doctorif rash occurs

WARNINGS

Warnings

• 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.

DOSAGE & ADMINISTRATION

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 of age: ask a doctor.

• Sun Protection MeasuresSpending 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 your time in the sun, especially from 10
a.m. – 2 p.m.

wear long-sleeved shirts, pants, hats, and sunglasses

INACTIVE INGREDIENT

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Bisabolol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, Caprylyl Glycol, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Ethylhexyl Methoxycrylene, Fragrance/Parfum, Glycerin, Hexylene Glycol, Phenoxyethanol, Polyester-5, Polyester-8, Polysorbate 20, Potassium Cetyl Phosphate, Sambucus Nigra (Elderberry) Fruit Extract, Sodium Silicoaluminate, Styrene/Acrylates Copolymer, Tocopheryl Acetate, Triethanolamine, Water/Aqua

OTHER SAFETY INFORMATION

Other information

• protect this product from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL

Jafra Sun

Spray on Sunscreen Broad Spectrum SPF 50

WATER RESISTANT (40 MINUTES)

125 ml 4.2 FL OZ (US)

INGREDIENTS AND APPEARANCE

JAFRA SUN SUNSCREEN BROAD SPECTRUM SPF 50 
avobenzone, homosalate, octisalate, octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-296
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM ALUMINOSILICATE (UNII: 058TS43PSM)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TROLAMINE (UNII: 9O3K93S3TK)
POLYESTER-5 (TG-38) (UNII: 2L9351NW8W)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
DIMETHICONE (UNII: 92RU3N3Y1O)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
LEVOMENOL (UNII: 24WE03BX2T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
EUROPEAN ELDERBERRY (UNII: BQY1UBX046)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
SHEA BUTTER (UNII: K49155WL9Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-296-01	125 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	01/14/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/14/2021

Labeler - Jafra Cosmetics International (041676479)

Establishment
Name	Address	ID/FEI	Business Operations
Distribuidora Comercial Jafra, S.A. de C.V.		951612777	manufacture(68828-296)