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

Spa Niacinamide And Vitamin E Hand Cream Broad Spectrum SPF 15 by

Drug Labeling and Warnings

Spa Niacinamide And Vitamin E Hand Cream Broad Spectrum SPF 15 by is a Otc medication manufactured, distributed, or labeled by Jafra Cosmetics International Inc, Distribuidora Comercial Jafra, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

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

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 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 swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply liberally and evenly 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

KEEP OUT OF REACH OF CHILDREN

Other information

• protect this product from excessive heat and direct sun

Inactive ingredients

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

SPL UNCLASSIFIED SECTION

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

Product label

INGREDIENTS AND APPEARANCE

SPA NIACINAMIDE AND VITAMIN E HAND CREAM BROAD SPECTRUM SPF 15 
avobenzone, homosalate, octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-003
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	5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	7 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)
.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)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
.BETA.-CITRONELLOL, (+/-)- (UNII: 565OK72VNF)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
GERANIOL (UNII: L837108USY)
EUGENOL (UNII: 3T8H1794QW)
CITRAL (UNII: T7EU0O9VPP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-003-01	1 in 1 CARTON	06/01/2022
1		75 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 68828-003-02	1 in 1 CARTON	06/01/2022	07/01/2025
2		7 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	06/01/2022

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(68828-003)