CLEAR SMART SHINE CONTROL SUNSCREEN BROAD SPECTRUM SPF 25- avobenzone,homosalate,octisalate,octocrylene cream

Clear Smart Shine Control Sunscreen Broad Spectrum SPF 25 by

Drug Labeling and Warnings

Clear Smart Shine Control Sunscreen Broad Spectrum SPF 25 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 INGREDIENT

Active Ingredients Purpose

Avobenzone 3% Sunscreen

Homosalate 10% Sunscreen

Octisalate 5% Sunscreen

Octocrylene 9% 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.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If product is swallowed, get medical help or contact a poison Control Center right away

INDICATIONS & USAGE

Stop use and ask a doctor if rash occurs.

WARNINGS

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.

DOSAGE & ADMINISTRATION

Directions

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

Inactive ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Acrylates/ Dimethicone Copolymer, Alcohol, Allantoin, Aluminum Starch Octenylsuccinate, Arachidyl Alcohol, Arachidyl Glucoside, Arginine, Behenyl Alcohol, Benzyl Alcohol, Bisabolol, Butyrospermum Parkii (Shea) Butter, Chlorphenesin, Cyclopentasiloxane, Dipropylene Glycol, Disodium EDTA, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Honey Extract, Hydrogenated Lecithin, Hydroxyethyl Acrylate/ Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Lauroyl Lysine, Lecithin, Maltodextrin, Menthyl Lactate, PEG-100 Stearate, Phenethyl Alcohol, Polyester-8, Polysorbate 60, Royal Jelly, Royal Jelly Powder, Sorbitan Isostearate, Styrene/Acrylates Copolymer, Tetrapeptide-45, Water/Aqua, Zymomonas Ferment Extract

PRINCIPAL DISPLAY PANEL

Royal Jelly

Clear Smart

Shine Control Sunscreen Broad Spectrum SPF 25 Protector

50ml e 1.7 FL OZ (US)

INGREDIENTS AND APPEARANCE

CLEAR SMART SHINE CONTROL SUNSCREEN BROAD SPECTRUM SPF 25 
avobenzone,homosalate,octisalate,octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-290
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	9 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)
ALLANTOIN (UNII: 344S277G0Z)
ARGININE (UNII: 94ZLA3W45F)
DOCOSANOL (UNII: 9G1OE216XY)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
LEVOMENOL (UNII: 24WE03BX2T)
WATER (UNII: 059QF0KO0R)
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SHEA BUTTER (UNII: K49155WL9Y)
GLYCERIN (UNII: PDC6A3C0OX)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
ISOHEXADECANE (UNII: 918X1OUF1E)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
POLYSORBATE 60 (UNII: CAL22UVI4M)
BENZYL ALCOHOL (UNII: LKG8494WBH)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PEG-100 STEARATE (UNII: YD01N1999R)
HONEY (UNII: Y9H1V576FH)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
ROYAL JELLY (UNII: L497I37F0C)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
ALCOHOL (UNII: 3K9958V90M)
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
CHLORPHENESIN (UNII: I670DAL4SZ)
LAUROYL LYSINE (UNII: 113171Q70B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-290-01	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/11/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	05/11/2020

Labeler - Jafra Cosmetics International Inc (041676479)

Establishment
Name	Address	ID/FEI	Business Operations
Jafra Manufacturing, S.A. de C.V.		814732061	manufacture(68828-290)