SUN FACE PROTECTOR SUNSCREEN BROAD SPECTRUM SPF 50- avobenzone, homosalate, octisalate, octocrylene cream

Sun face protector sunscreen broad spectrum SPF 50 by

Drug Labeling and Warnings

Sun face protector 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 Ingredients           Purpose

Avobenzone 3%..............Sunscreen

Homosalate 10%.............Sunscreen

Octisalate 5%..................Sunscreen

Octocrylene 10%.............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.

KEEP OUT OF REACH OF CHILDREN

INDICATIONS & USAGE

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.

Stop use and ask a doctor if rash occurs

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

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 time in the sun, especially from 10 a.m. - 2 p.m.
      wear long-sleeved shirts, pants, hats, and sunglasses

Other information

protect this product form excessive heat and direct sun

Inactive Ingredients

Water, Polyester-8, Styrene/Acrylates Copolymer, Cetyl Alcohol, VP/Eicosene Copolymer, Dicaprylyl Carbonate, Glyceryl Stearate, PEG -100 Stearate, Phenoxyethanol, Arginine, Bisabolol, Glycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Tocopheryl Acetate, Fragrance, Ethylhexylglycerin, Disodium EDTA, Panthenol, Sambucus Nigra Fruit Extract, Benzyl Salicylate, Coumarin, Butylphenyl Methylpropional, Linalool, Hydroxycitronellal

OTHER SAFETY INFORMATION

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

Product label

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-295
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
LEVOMENOL (UNII: 24WE03BX2T)
CETYL ALCOHOL (UNII: 936JST6JCN)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PEG-100 STEARATE (UNII: YD01N1999R)
PANTHENOL (UNII: WV9CM0O67Z)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
ARGININE (UNII: 94ZLA3W45F)
GLYCERIN (UNII: PDC6A3C0OX)
EUROPEAN ELDERBERRY (UNII: BQY1UBX046)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
WATER (UNII: 059QF0KO0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)
COUMARIN (UNII: A4VZ22K1WT)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-295-01	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/14/2021
2	NDC: 68828-295-02	7.5 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/14/2021	11/01/2024

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(68828-295)