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

INDICATIONS & USAGE

WARNINGS

Warnings

• For external use only
• Do not useon damaged or broken skin
• When using this productkeep out of eyes. Rinse with water to remove.
• Stop use and ask a doctor if rash occurs
• Keep out of reach of children.If swallowed, get medical help or contact a poison Control Center right away

DOSAGE & ADMINISTRATION

Directions

• Apply liberally and evenly 15 minutes before sun exposure
• reapply:

    after 40 minutes of swimming or sweating
    immediately after towel drying
    at least every 2 hours

• Children under 6 months of age: 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 your time in the sun, especially from 10a.m. – 2 p.m.

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

OTHER SAFETY INFORMATION

Other information

• protect this product from excessive heat and direct sun

INACTIVE INGREDIENT

Inactive Ingredients

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

SPL UNCLASSIFIED SECTION

Questions?Call 1-800-551-2345 or visit www.jafra.com

Product label

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 COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)
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)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
COUMARIN (UNII: A4VZ22K1WT)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)

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 - Distribuidora Comercial Jafra, S.A. de C.V. (951612777)

Registrant - Jafra cosmetics international Inc. (031183599)

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