Tinted Sun Face Protector Sunscreen Broad Spectrum SPF 50 by Jafra Cosmetics International Inc / Distribuidora Comercial Jafra, S.A. de C.V.

Tinted Sun Face Protector Sunscreen Broad Spectrum SPF 50 by

Drug Labeling and Warnings

Tinted Sun Face Protector Sunscreen Broad Spectrum SPF 50 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]

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

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Active ingredient

Avobenzone 3%
Homosalate 10%
Octisalate 5%
Octocrylene 10%

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

Stop use and ask a doctorif rash occurs

When using this productkeep out of eyes. Rinse with water to remove

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: 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-sleeve shirts, pants, hats and sunglasses

Inactive ingredients

Acrylates/Ammonium Methacrylate Copolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Arginine, Bisabolol, Cellulose Acetate,Cetyl Alcohol, Dicaprylyl Carbonate, Disodium EDTA, Ethylhexylglycerin,Fragrance/Parfum, Glycerin, Glyceryl Stearate, Iron Oxides/CI 77491/CI 77492/CI 77499, Magnesium Stearate, Propylene Glycol Stearate, Panthenol, PEG-100 Stearate, Phenoxyethanol, Polyester-8, Sambucus Nigra (Elderberry) Fruit Extract, Styrene/Acrylates Copolymer, Titanium Dioxide (CI 77891), Tocopheryl Acetate, VP/Eicosene Copolymer, Water/Aqua

Other information

Protect this product from excessive heat and direct sun

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-508
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	10 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
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
ARGININE (UNII: 94ZLA3W45F)
LEVOMENOL (UNII: 24WE03BX2T)
CELLULOSE ACETATE (UNII: 3J2P07GVB6)
CETYL ALCOHOL (UNII: 936JST6JCN)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MAGNESIUM STEARATE (UNII: 70097M6I30)
PROPYLENE GLYCOL MONOSTEARATE (UNII: MZM1I680W0)
PANTHENOL (UNII: WV9CM0O67Z)
PEG-100 STEARATE (UNII: YD01N1999R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
EUROPEAN ELDERBERRY (UNII: BQY1UBX046)
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-508-01	1 in 1 CARTON	08/29/2022	12/31/2023
1		7.5 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	08/29/2022	12/31/2023

Labeler - Jafra Cosmetics International Inc (041676479)

Establishment
Name	Address	ID/FEI	Business Operations
Distribuidora Comercial Jafra, S.A. de C.V.		951612777	manufacture(68828-508)

Revised: 1/2024

Document Id: 0e36f174-0357-37ad-e063-6394a90a29b6

34390-5

Set id: 29dd690c-0ec5-4980-a832-75e32212e623

Version: 2

Effective Time: 20240105