Label: JOUVALLE DEEP NOURISHING LUMINOSITY DAY- octinoxate, homosalate, octisilate, oxybenzone and avobenzone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 73191-125-19 - Packager: Florida Private Labeling LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated January 26, 2021
If you are a consumer or patient please visit this version.
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- Active Ingredients
- Purpose
- Uses
- Warnings
- Stop using this product and ask doctor if redness develops and lasts.
- Keep out of reach of children.
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Directions
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- After cleansing, apply liberally and evenly 15 minutes before sun exposure. Smooth over face and neck and chest daily for optimal results.
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- Reapply at least every two (2) hours.
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- Use water resistant sunscreen if swimming or sweating.
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:
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- limit time in the sun, especially from 10 a.m. – 2 p.m.
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- wear long-sleeved shirts, pants, hats and sunglasses
For children under 6 months of age: Ask doctor.
- Other Information
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Inactive Ingredients
Aqua, C12-15 Alkyl Benzoate, Glycerin, Glyceryl Stearate, Stearic Acid, PEG-100 Stearate, Tocopherol, Retinyl Palmitate, Sodium Hyaluronate, Euterpe Oleracea Fruit Extract, Aloe Barbadensis Leaf Extract, Camellia Sinensis Leaf Extract, Sodium PCA, Polysorbate 60, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Carbomer, Disodium EDTA, Phenoxyethanol, Ethylhexylglycerin.
- Package/Label Principal Display Panel
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INGREDIENTS AND APPEARANCE
JOUVALLE DEEP NOURISHING LUMINOSITY DAY
octinoxate, homosalate, octisilate, oxybenzone and avobenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73191-125 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.4 g in 100 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 6.2 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5.2 g in 100 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 3.1 g in 100 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1.5 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) MYRISTIC ACID (UNII: 0I3V7S25AW) PALMITIC ACID (UNII: 2V16EO95H1) STEARIC ACID (UNII: 4ELV7Z65AP) TOCOPHEROL (UNII: R0ZB2556P8) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) HYALURONATE SODIUM (UNII: YSE9PPT4TH) ACAI (UNII: 46AM2VJ0AW) ALOE VERA LEAF (UNII: ZY81Z83H0X) GREEN TEA LEAF (UNII: W2ZU1RY8B0) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) POLYSORBATE 60 (UNII: CAL22UVI4M) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) EDETATE DISODIUM (UNII: 7FLD91C86K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73191-125-19 1 in 1 CARTON 08/01/2019 1 50 g in 1 JAR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 08/01/2019 Labeler - Florida Private Labeling LLC (081081732)