Sun Oil-Free Facial Sunscreen Broad Spectrum SPF 50 by Jafra Cosmetics International Inc / Distribuidora Comercial Jafra, S.A. de C.V.

Sun Oil-Free Facial Sunscreen Broad Spectrum SPF 50 by

Drug Labeling and Warnings

Sun Oil-Free Facial 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]

SUN OIL-FREE FACIAL SUNSCREEN BROAD SPECTRUM SPF 50- avobenzone, homosalate, octisalate, octocrylene cream 
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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Active ingredient

Avobenzone 3%
Homosalate 10%
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 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

Water/Aqua, Glyceryl Stearate, PEG-100 Stearate, Styrene/Acrylates Copolymer, Aluminum Starch Octenylsuccinate, Lauroyl Lysine, Cyclopentasiloxane, Acrylates/Dimethicone Copolymer, Arachidyl Alcohol, Behenyl Alcohol, Arachidyl Glucoside, Bisabolol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Arginine, Disodium EDTA, Panthenol, Allantoin, Tocopheryl Acetate, Thermus Thermophillus Ferment, Glycerin, Ipomoea Batatas Tuber Extract, Withania Somniferia (Winter Cherry) Extract, Vigna Radiata (Mung Bean) Extract, Hydroxyacetophenone, 1,2-Hexanediol, Caprylyl Glycol

Other information

Protect this product from excessive heat and direct sun

Product label

SUN OIL-FREE FACIAL SUNSCREEN BROAD SPECTRUM SPF 50 
avobenzone, homosalate, octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-505
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	7 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
LAUROYL LYSINE (UNII: 113171Q70B)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
DOCOSANOL (UNII: 9G1OE216XY)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
ARGININE (UNII: 94ZLA3W45F)
LEVOMENOL (UNII: 24WE03BX2T)
SWEET POTATO (UNII: M9WGG9Z9GK)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
PEG-100 STEARATE (UNII: YD01N1999R)
ALLANTOIN (UNII: 344S277G0Z)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PANTHENOL (UNII: WV9CM0O67Z)
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-505-01	1 in 1 CARTON	09/06/2022	02/01/2023
1		50 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	09/06/2022	02/01/2023

Labeler - Jafra Cosmetics International Inc (041676479)

Establishment
Name	Address	ID/FEI	Business Operations
Distribuidora Comercial Jafra, S.A. de C.V.		951612777	manufacture(68828-505)

Revised: 7/2023

Document Id: 014f00f9-34d1-4aca-e063-6294a90a1019

34390-5

Set id: 7dc97218-27fb-4cf6-be38-c91d1d1079dd

Version: 2

Effective Time: 20230725