Jafra Royal Luna Bright Kit

Jafra Royal Luna Bright Kit
SPL v3
SPL
SPL Set ID a0082f86-5e5a-49d3-9dae-30b88117f70c
Route
TOPICAL
Published
Effective Date 2023-07-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3 g) Homosalate (10 g) Octisalate (5 g) Octocrylene (7 g)
Inactive Ingredients
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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Completed Since 2022-01-12 Until 2023-05-01

Description

Avobenzone 3% Homosalate 10% Octisalate 5% Octocrylene 7%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3% Homosalate 10% Octisalate 5% Octocrylene 7%

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.

Section 50565-1

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

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.

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 measures including:
  • limit time in the sun, especially from 10 a.m. - 2 p.m.
  • wear long-sleeve shirts, pants, hats, and sunglasses
Product Label

Other Information

Protect this product from excessive heat and direct sun

Active Ingredient(s)

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 7%

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, Phenethyl Alcohol, Polysorbate 60, Royal Jelly, Royal Jelly Powder, Silica, Sorbitan Isostearate, Styrene/Acrylates Copolymer, Tetrapeptide-45, Theobroma Cacao (Cocoa) Seed Extract, Water/Aqua, Yeast Extract


Structured Label Content

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.

Section 50565-1 (50565-1)

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

Purpose

Sunscreen

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.

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 measures including:
  • limit time in the sun, especially from 10 a.m. - 2 p.m.
  • wear long-sleeve shirts, pants, hats, and sunglasses
Product Label (Product label)

Other Information (Other information)

Protect this product from excessive heat and direct sun

Active Ingredient(s)

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 7%

Inactive Ingredients (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, Phenethyl Alcohol, Polysorbate 60, Royal Jelly, Royal Jelly Powder, Silica, Sorbitan Isostearate, Styrene/Acrylates Copolymer, Tetrapeptide-45, Theobroma Cacao (Cocoa) Seed Extract, Water/Aqua, Yeast Extract


Advanced Ingredient Data


Raw Label Data

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