SPA NIACINAMIDE AND VITAMIN E HAND CREAM BROAD SPECTRUM SPF 15- avobenzone, homosalate, octisalate, octocrylene cream 
Jafra Cosmetics International Inc

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Active ingredients

Avobenzone 3%
Homosalate 5%
Octisalate 5%
Octocrylene 7%

Purpose

Sunscreen

Uses

Warning

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.

Direction

• Apply liberally 15 minutes before sun exposure
• Reapply at least every 2 hours
• Use a water resistant sunscreen if swimming or sweating
• 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

Water, Glycerin, Polyester-8, Butyrospermum Parkii (Shea) Butter, Dimethicone, Styrene/Acrylates Copolymer, Ethylhexylglycerin, Benzyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Arachidyl Alcohol, Saccharide Isomerate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Behenyl Alcohol, Isohexadecane, Niacinamide, Hydroxyethyl Urea, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Tocopheryl Acetate, Arginine, Chlorphenesin, Arachidyl Glucoside, Disodium EDTA, Panthenol, Persea Gratissima (Avocado) Oil, Phytosterols, Sorbitan Isostearate, Polysorbate 60, Olea Europaea (Olive) Fruit Oil, Fragrance

Other information

Protect this product from excessive heat and direct sun

Product label

image description
SPA NIACINAMIDE AND VITAMIN E HAND CREAM BROAD SPECTRUM SPF 15 
avobenzone, homosalate, octisalate, octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-003
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) HOMOSALATE5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE7 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
SHEA BUTTER (UNII: K49155WL9Y)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
DOCOSANOL (UNII: 9G1OE216XY)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
NIACINAMIDE (UNII: 25X51I8RD4)  
HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ARGININE (UNII: 94ZLA3W45F)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
PANTHENOL (UNII: WV9CM0O67Z)  
AVOCADO OIL (UNII: 6VNO72PFC1)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68828-003-011 in 1 CARTON06/01/2022
175 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:68828-003-021 in 1 CARTON06/01/2022
27 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02006/01/2022
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(68828-003)

Revised: 12/2023
Document Id: 0daa8799-54e9-25fc-e063-6294a90ac46a
Set id: 865057ce-f617-4232-a60e-e23c120b0a73
Version: 3
Effective Time: 20231229
 
Jafra Cosmetics International Inc