JAFRA SKIN GLOW FACE CREAM BROAD SPECTRUM SPF 15 SUNSCREEN- homosalate, octisalate, avobenzone,octocrylene cream

JAFRA SKIN Glow Face Cream Broad Spectrum SPF 15 Sunscreen by

Drug Labeling and Warnings

JAFRA SKIN Glow Face Cream Broad Spectrum SPF 15 Sunscreen by is a Otc medication manufactured, distributed, or labeled by Distribuidora Comercial Jafra, S.A. de C.V, Jafra Cosmetics International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients                      Purpose

Avobenzone 3%                         Sunscreen

Homosalate 7%                         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

Warnings

For external use only

Do not use ondamaged 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 product is swallowed, get medical help or contact a Poison Control Center right away.

KEEP OUT OF REACH OF CHILDREN

Directions

• shake well
• 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: 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 from excessive heat and direct sun

Inactive Ingredients

Water/Aqua, Glycerin, Ammonium Polyacryloyldimethyl Taurate, PEG-12 Dimethicone, Mica/CI 77019, Polysorbate 20, Niacinamide, Mica, Phenoxyethanol, Titanium Dioxide/CI 77891, Iron Oxides/CI 77491/CI 77499, Tocopheryl Acetate, Silica Dimethyl Silylate, Polyacrylamide, Ascorbyl Palmitate, Ethylhexylglycerin, Ceratonia Siliqua (Carob) Fruit Extract, C13-14 Isoalkane, Tetrasodium EDTA, Triethoxycaprylylsilane, Yeast Extract/Faex, Sodium Hyaluronate, Laureth-7, Silica, 1,2-Hexanediol, Caprylyl Glycol

Questions?

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

Product label

INGREDIENTS AND APPEARANCE

JAFRA SKIN GLOW FACE CREAM BROAD SPECTRUM SPF 15 SUNSCREEN 
homosalate, octisalate, avobenzone,octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-021
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	7 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
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
AMMONIUM POLYACRYLOYLDIMETHYL TAURATE (UNII: F01RIY4371)
PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)
MICA (UNII: V8A1AW0880)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
NIACINAMIDE (UNII: 25X51I8RD4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
SODIUM ACRYLOYLDIMETHYLTAURATE-ACRYLAMIDE COPOLYMER (1:1; 90000-150000 MPA.S) (UNII: 5F4963KLHS)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CAROB (UNII: 5MG5Z946UO)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
EDETATE SODIUM (UNII: MP1J8420LU)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
LAURETH-7 (UNII: Z95S6G8201)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-021-01	1 in 1 CARTON	02/14/2024
1		30 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	02/14/2024

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(68828-021)