SOLAR PROTECTION FLUID BROAD SPECTRUM SPF 50- avobenzone, homosalate, octisalate, octocrylene cream

Solar Protection Fluid by

Drug Labeling and Warnings

Solar Protection Fluid by is a Otc medication manufactured, distributed, or labeled by JAFRA COSMETICS INTERNATIONAL, Jafra Manufacturing, S.A. de C.V. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients        Purpose

Avobenzone 3%         Sunscreen

Homosalate 10%        Suncreen

Octisalate 5%            Suncreen

Octocrylene 7%         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 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 children under 6 months: Ask a doctor
• Sun Protection Measures. Spending time in the sun icreases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Specturm SPF 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 INGREDIENT

Water/Aqual, Styrene/Acrylate Copolymer, Glyceryl Stearate, PEG-100 Stearate, Aluminum Starch Octenylsuccinate, Lauroyl Lysine, Arachidyl Alcohol, Behenyl Alcohol, Arachidyl Glucoside, Ethylhexylglycerin, Benzyl Alcohol, Bisabolol, Royal Jelly, Cyclopentasiloxane, Acrylates/Dimethicon Copolymer, Cocos Nucifera, Moringa Oleifera, Fragrance/Parfum, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Disodium EDTA, Allantoin, Arginine, Chlorphenesin, Cichorium Intybus (Chicory) Root Extract, Kappaphycus Alvarezii Extract, Glycerin, Polygonum Aviculare Extract, Sodium Ascorbyl Phosphate, Benzyl Salicylate, Limonene, Hydroxycitronellal, Butylphenyl Methylpropional (Lillial), Linalool

PRINCIPAL DISPLAY PANEL

JAFRA

Royal Jelly

Solar Protection Fluid

Broad Spectrum SPF 50

50 ml   1.7 FL OZ (US)

INGREDIENTS AND APPEARANCE

SOLAR PROTECTION FLUID  BROAD SPECTRUM SPF 50
avobenzone, homosalate, octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-240
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
WATER (UNII: 059QF0KO0R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
LAUROYL LYSINE (UNII: 113171Q70B)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
DOCOSANOL (UNII: 9G1OE216XY)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
BENZYL ALCOHOL (UNII: LKG8494WBH)
.ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)
ROYAL JELLY (UNII: L497I37F0C)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
COCOS NUCIFERA WHOLE (UNII: 245J88W96L)
MORINGA OLEIFERA WHOLE (UNII: 5JH60A416W)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALLANTOIN (UNII: 344S277G0Z)
ARGININE (UNII: 94ZLA3W45F)
CHLORPHENESIN (UNII: I670DAL4SZ)
CHICORY ROOT (UNII: 090CTY533N)
KAPPAPHYCUS ALVAREZII (UNII: T479H08K2O)
GLYCERIN (UNII: PDC6A3C0OX)
POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
LIMONENE, (+/-)- (UNII: 9MC3I34447)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
LINALOOL, (+/-)- (UNII: D81QY6I88E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-240-02	1 in 1 BOX	08/10/2015
1	NDC: 68828-240-01	50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 68828-240-03	1 mL in 1 PACKAGE; Type 0: Not a Combination Product	02/02/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	08/10/2015

Labeler - JAFRA COSMETICS INTERNATIONAL (041676479)

Registrant - JAFRA COSMETICS INTERNATIONAL (041676479)

Establishment
Name	Address	ID/FEI	Business Operations
Jafra Manufacturing, S.A. de C.V		814732061	manufacture(68828-240)