Sun Face Protector Broad Spectrum 50+

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 Inc, Jafra Manufacturing, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SUN FACE PROTECTOR SUNSCREEN BROAD SPECTRUM SPF 50- avobenzone, homosalate, octisalate,octocrylene, oxybenzone lotion 
Jafra Cosmetics International Inc

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.

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Sun Face Protector Broad Spectrum 50+

Active ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 10%

Oxybenzone 5%

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 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 doctorif rash occurs

Keep out of reach of children.If 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 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 10 a.m. – 2 p.m.
wear long-sleeved shirts, pants, hats, and sunglasses

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Acrylates/Dimethicone Copolymer, Acrylates/Octylacrylamide Copolymer, Adipic Acid/Diglycol Crosspolymer, Allantoin, Aluminum Starch Octenylsuccinate, Arachidyl Alcohol, Arachidyl Glucoside, Arginine, Avena Sativa (Oat) Kernel Extract, Azadirachta Indica Extract, Behenyl Alcohol, Bisabolol, Butylene Glycol, Chlorphenesin, Cyclopentasiloxane, Dimethicone Copolyol, Disodium EDTA, Ethoxylated Castor Oil, Ethylhexylglycerin, Fragrance/Parfum, Glyceryl Stearate, Glycyrrhiza Glabra (Licorice) Extract, Ipomoea Batatas Tuber Extract, Iron Oxides/CI 77491/CI 77492/CI 77499, Lauroyl Lysine, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Methylisothiazolinone, Mica, Moringa Oleifera Extract, Panthenol, PEG-100 Stearate, PEG-12 Dimethicone, Polysorbate 20, Silica, Styrene/Acrylates Copolymer, Tagetes Erecta (African Marigold) Extract, Tocopheryl Acetate, Vetiveria Zizanoides (Khus Root) Extract, Water/Aqua, Withania Somnifera (Winter Cherry) Extract

Other information

Protect this product form excessive heat and direct sun

Product label

image descriptionimage descriptionimage descriptionimage description

SUN FACE PROTECTOR SUNSCREEN BROAD SPECTRUM SPF 50 
avobenzone, homosalate, octisalate,octocrylene, oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 68828-752
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)  
TAGETES ERECTA WHOLE (UNII: C7YOV7LU4Q)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CHRYSOPOGON ZIZANIOIDES ROOT (UNII: 37TB8LUP9Z)  
WATER (UNII: 059QF0KO0R)  
WITHANIA SOMNIFERA ROOT (UNII: V038D626IF)  
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
ADIPIC ACID/DIGLYCOL CROSSPOLYMER (20000 MPA.S) (UNII: R9TPS68K19)  
ALLANTOIN (UNII: 344S277G0Z)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
ARGININE (UNII: 94ZLA3W45F)  
OAT (UNII: Z6J799EAJK)  
AZADIRACHTA INDICA BARK (UNII: G580B439YI)  
DOCOSANOL (UNII: 9G1OE216XY)  
LEVOMENOL (UNII: 24WE03BX2T)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
LICORICE (UNII: 61ZBX54883)  
SWEET POTATO (UNII: M9WGG9Z9GK)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
LAUROYL LYSINE (UNII: 113171Q70B)  
TEA TREE OIL (UNII: VIF565UC2G)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
MICA (UNII: V8A1AW0880)  
MORINGA OLEIFERA BARK (UNII: 1X2218R709)  
PANTHENOL (UNII: WV9CM0O67Z)  
PEG-100 STEARATE (UNII: YD01N1999R)  
PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 68828-752-011 in 1 CARTON01/11/202202/01/2023
150 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC: 68828-752-021 in 1 CARTON01/11/202202/01/2023
275 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/11/202202/01/2023
Labeler - Jafra Cosmetics International Inc (041676479)
Registrant - Jafra Cosmetics International Inc (041676479)
Establishment
NameAddressID/FEIBusiness Operations
Distribuidora Comercial Jafra, S.A. de C.V.951612777manufacture(68828-752)

Revised: 7/2023