OTC Medication Information: Jafra Royal Luna Bright Kit

JAFRA ROYAL LUNA BRIGHT KIT- avobenzone, homosalate, octisalate, octocrylene
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.

Active Ingredients Purpose

Avobenzone 3% Sunscreen

Homosalate 10% Sunscreen

Octisalate 5% Sunscreen

Oxybenzone 7% 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

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

Stop use and ask a doctor if rash occurs.

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.

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 skin aging. to decrease

this risk, regularly use a sunscreen with a Broad Spectrum SPFvalue of 15 or higher and other sun 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/C10-30 Alkyl Acrylate Crosspolymer, Acrylates/Dimethicone Copolymer, Allantoin, Aluminum Starch octenylsuccinate, Arachidyl Alcohol, Behenyl Alcohol, Arachidyl Glucoside, Arginine, Benzyl Alcohol, Bisabolol, Butyrospermum Parkii (Shea) Butter, Butylene Glycol, Chlorphenesin, Cyclopentasiloxane, Dipropylene Glycol, Disodium EDTA, Ethylhexylglycerin, Fragrance/Parfum, Glycerin, Glyceryl Stearate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Lauroyl Lysine, Hydrogenated Lecithin, Lecithin, Maltodextrin, PEG-100 stearate, Palmaria Palmata (red seaweed) extract, Phenoxyethanol, Phenenthyl Alcohol, Polysorbate, Royal Jelly, Royal Jelly Powder, Silica, Sorbitan Isostearate, Styrene/Acrylates Copolymer, Tetrapeptide-45 , Theobroma Cacao (Cocoa) Seed Extract, Water/Aqua, Yeast Extract

Jafra Royal

Royal Jelly

Luna Bright

Contains 4 samples

1 Refining Gel Cleanser

7.5ml .25 FL OZ

1 Brightening Hydrogel Moisturizer

7.5ml .25 FL OZ

1 Brightening Serum Concentrate

7.5ml .25 FL OZ

1 Brightening Daily Protector Broad SpectrumSPF 30

7.5ml .25 FL OZ

Total Contents 30ml 1 FL OZ

luna bright kit front
(click image for full-size original)
luna bright kit back
(click image for full-size original)
Established Pharmacological Class
Substance Pharmacological Class
Brightening Serum Concentrate Other Skin Care Preparations
Brightening Hydrogel Moisturizer Face and Neck (excluding shaving preparations)
Refining Gel Cleanser Face and Neck (excluding shaving preparations)
JAFRA ROYAL LUNA BRIGHT KIT
avobenzone, homosalate, octisalate, octocrylene kit
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68828-285
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68828-285-01 1 KIT in 1 KIT None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 TUBE 7.5
Part 2 1 TUBE 7.5
Part 3 1 TUBE 7.5
Part 4 1 TUBE 7.5 mL
Part 1 of 4
BRIGHTENING SERUM CONCENTRATE
Product Information
Ingredients
Ingredient Name Quantity
WATER
GLYCERIN
CAPRYLHYDROXAMIC ACID
1,2-HEXANEDIOL
PROPANEDIOL
SODIUM POLYACRYLATE (8000 MW)
DIMETHICONE
CYCLOMETHICONE 5
TRIDECETH-6
PEG/PPG-18/18 DIMETHICONE
HYDROGENATED SOYBEAN LECITHIN
SHEA BUTTER
DULSE
HYALURONATE SODIUM
TREHALOSE
SODIUM PYRROLIDONE CARBOXYLATE
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7)
UREA
TRIACETIN
TOCOPHEROL
EDETATE TRISODIUM
PHENYLETHYL ALCOHOL
ETHYLHEXYLGLYCERIN
MALTODEXTRIN
LECITHIN, SOYBEAN
DIPROPYLENE GLYCOL
ROYAL JELLY
PHENOXYETHANOL
ISOMETHYL-.ALPHA.-IONONE
BUTYLPHENYL METHYLPROPIONAL
.BETA.-CITRONELLOL, (R)-
.ALPHA.-HEXYLCINNAMALDEHYDE
HYDROXYCITRONELLAL
LIMONENE, (+)-
LINALOOL, (+)-
Packaging
# Item Code Package Description Multilevel Packaging
1 7.5 in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Cosmetic
Part 2 of 4
BRIGHTENING HYDROGEL MOISTURIZER
Product Information
Ingredients
Ingredient Name Quantity
WATER
GLYCERIN
DULSE
CYCLOMETHICONE 5
CYCLOMETHICONE 6
SILICON DIOXIDE
HYALURONATE SODIUM
TREHALOSE
SODIUM PYRROLIDONE CARBOXYLATE
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7)
UREA
TRIACETIN
DIMETHICONE
PEG-10 DIMETHICONE (600 CST)
DISTEARDIMONIUM HECTORITE
BIS-PEG-18 METHYL ETHER DIMETHYL SILANE
HYDROGENATED SOYBEAN LECITHIN
SHEA BUTTER
PHENOXYETHANOL
CAPRYLYL GLYCOL
HEXYLENE GLYCOL
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)
MEDIUM-CHAIN TRIGLYCERIDES
HYDROXYETHYL UREA
TROLAMINE
PHENYLETHYL ALCOHOL
ETHYLHEXYLGLYCERIN
MALTODEXTRIN
LECITHIN, SOYBEAN
DIPROPYLENE GLYCOL
ROYAL JELLY
Packaging
# Item Code Package Description Multilevel Packaging
1 7.5 in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Cosmetic
Part 3 of 4
REFINING GEL CLEANSER
Product Information
Ingredients
Ingredient Name Quantity
WATER
COCAMIDOPROPYL BETAINE
DECYL GLUCOSIDE
PEG-7 GLYCERYL COCOATE
COCO GLUCOSIDE
SODIUM LAUROYL SARCOSINATE
GLYCERIN
HYDROGENATED SOYBEAN LECITHIN
SHEA BUTTER
PEG-150 PENTAERYTHRITYL TETRASTEARATE
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)
GLYCOL STEARATE
WINE GRAPE JUICE
XANTHAN GUM
POTASSIUM SORBATE
TROLAMINE
MICA
BISMUTH OXYCHLORIDE
CARMINIC ACID
PHENYLETHYL ALCOHOL
ETHYLHEXYLGLYCERIN
MALTODEXTRIN
LECITHIN, SOYBEAN
DIPROPYLENE GLYCOL
ROYAL JELLY
PHENOXYETHANOL
HYALURONATE SODIUM
ISOMETHYL-.ALPHA.-IONONE
BUTYLPHENYL METHYLPROPIONAL
.BETA.-CITRONELLOL, (R)-
.ALPHA.-HEXYLCINNAMALDEHYDE
HYDROXYCITRONELLAL
LIMONENE, (+)-
LINALOOL, (+)-
Packaging
# Item Code Package Description Multilevel Packaging
1 7.5 in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Cosmetic
Part 4 of 4
BRIGHTENING DAILY PROTECTOR BROAD SPECTRUM SPF 30
avobenzone, homosalate, octisalate, octocrylene jelly
Product Information
Item Code (Source) NDC:68828-286
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE (AVOBENZONE) AVOBENZONE 3 g in 100 mL
HOMOSALATE (HOMOSALATE) HOMOSALATE 10 g in 100 mL
OCTISALATE (OCTISALATE) OCTISALATE 5 g in 100 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 7 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)
LAUROYL LYSINE
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)
ARACHIDYL ALCOHOL
DOCOSANOL
ARGININE
LEVOMENOL
SHEA BUTTER
BUTYLENE GLYCOL
CHLORPHENESIN
ETHYLHEXYLGLYCERIN
PHENOXYETHANOL
ALLANTOIN, (+)-
ALUMINUM STARCH OCTENYLSUCCINATE
ARACHIDYL GLUCOSIDE
BENZYL ALCOHOL
CYCLOMETHICONE 5
EDETATE DISODIUM
ISOHEXADECANE
HYDROGENATED SOYBEAN LECITHIN
LECITHIN, SOYBEAN
MALTODEXTRIN
PEG-100 STEARATE
DULSE
POLYSORBATE 60
ROYAL JELLY
SILICON DIOXIDE
PEG-20 SORBITAN ISOSTEARATE
COCOA
GLYCERYL MONOSTEARATE
GLYCERIN
WATER
DIPROPYLENE GLYCOL
PHENYLETHYL ALCOHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68828-286-01 7.5 mL in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 01/09/2019
Labeler — JAFRA COSMETICS INTERNATIONAL INC (041676479)
Establishment
Name Address ID/FEI Operations
Jafra Manufacturing, S.A. de C.V. 814732061 manufacture (68828-285), manufacture (68828-286)

Revised: 01/2019 JAFRA COSMETICS INTERNATIONAL INC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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