Label: CELLULAR RADIANCE EMULSION SPF 30 LA PRAIRIE- avobenzone, octinoxate, octisalate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 68807-320-11 - Packager: Temmentec Ag
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 3, 2017
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
Active Ingredients Purpose
Octinoxate 7.5% Sunscreen
Octisalate 5.0% Sunscreen
Oxybenzone 3.0% Sunscreen
Uses
helps prevent sunburn
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Stop use and ask a doctor if rash occurs
Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.
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 daily after cleansing and toning
smooth over face and throat
apply liberally 15 minutes before sun exposure
children under 6 months of age: Ask a doctor
reapply at least every 2 hours
use a water resistant sunscreen if swimming or sweating
Inactive Ingredients:
Water (Aqua), C12-15 Alkyl Ethylhexanoate, Cetyl Alcohol, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Sea Water (Maris Aqua), Dimethicone, Behenyl Alcohol, Stearyl Alcohol, Butylene Glycol, Propylene Glycol, Caprylic/Capric Triglyceride, Cyclopentasiloxane, Batyl Alcohol, Glycoproteins, Panax Ginseng Root Extract, Equisetum Arvense (Horsetail) Extract, Phytosterols,
Salicornia Herbacea Extract, Niacinamide, Hydrolyzed Oat Protein, Alpinia Galanga Leaf Extract, Quartz,
Disodium Adenosine Triphosphate,Tocopherol, Carica Papaya (Papaya) Fruit Extract, Cholesteryl Nonanoate,
Cimicifuga Racemosa Root Extract, Zinc Gluconate, Hydrogenated Lecithin, Trifolium Pratense (Clover) Flower Extract, Copper Gluconate, Gold, PEG-20 Phytosterol, Actinidia Polygama Fruit Extract, Acetyl Heptapeptide, Colloidal Gold, Cholesteryl Oleate, Dimethylmethoxy Chromanyl Palmitate, Corallina Officinalis Extract, Carbomer, Cholsteryl Stearate, Acrylates Copolymer, Boswellia Serrata Resin Extract, Ammonium Acryloyldimethltaurate/VP Copolymer, Phormidium Persicinum Extract, Caprylyl Glycol, Dextran, Magnesium Asparate, Glyceryl Stearate, Disodium EDTA, Xanthan Gum, BHT, Fragrance (Parfum), Linalool, Hexyl Cinnamal, Hydroxycitronellal, Alpha-Isomethyl Ionone, Geraniol, Citronellol, Benzyl Benzoate, Butylphenyl Methylpropional, Evernia Furfuracea (Treemoss) Extract, Eugenol, Benzyl Salicylate, Limonene, Phenoxyethanol, Sorbic Acid, Methylparaben, Mica, Titanium Dioxide (CI 77891), Red (CI 14700), Yellow 5 (CI 19140) - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CELLULAR RADIANCE EMULSION SPF 30 LA PRAIRIE
avobenzone, octinoxate, octisalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68807-320 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 75 mg in 100 kg OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 50 mg in 100 kg OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 30 mg in 100 kg Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CETYL ALCOHOL (UNII: 936JST6JCN) GLYCERIN (UNII: PDC6A3C0OX) SUNFLOWER OIL (UNII: 3W1JG795YI) DIMETHICONE (UNII: 92RU3N3Y1O) DOCOSANOL (UNII: 9G1OE216XY) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) BATILOL (UNII: 39YR661C4U) ASIAN GINSENG (UNII: CUQ3A77YXI) EQUISETUM ARVENSE BRANCH (UNII: 1L0VKZ185E) SALICORNIA EUROPAEA (UNII: 6ADL50JAKW) NIACINAMIDE (UNII: 25X51I8RD4) ALPINIA GALANGA LEAF (UNII: GD58MI8TU5) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ADENOSINE TRIPHOSPHATE DISODIUM (UNII: 5L51B4DR1G) TOCOPHEROL (UNII: R0ZB2556P8) PAPAYA (UNII: KU94FIY6JB) CHOLESTERYL NONANOATE (UNII: 4313O7P4XW) BLACK COHOSH (UNII: K73E24S6X9) ZINC GLUCONATE (UNII: U6WSN5SQ1Z) TRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828) COPPER GLUCONATE (UNII: RV823G6G67) ACTINIDIA POLYGAMA FRUIT (UNII: CJA97047JF) GOLD (UNII: 79Y1949PYO) CHOLESTERYL OLEATE (UNII: 3DPK9KFN2M) CORALLINA OFFICINALIS (UNII: 4004498D06) CARBOMER 934 (UNII: Z135WT9208) CHOLESTERYL STEARATE (UNII: I1Q82N9DYQ) INDIAN FRANKINCENSE (UNII: 4PW41QCO2M) AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) PHORMIDIUM PERSICINUM (UNII: ZA983U4810) CAPRYLYL GLYCOL (UNII: 00YIU5438U) DEXTRAN 1 (UNII: I8LHQ0D645) MAGNESIUM ASPARTATE (UNII: R17X820ROL) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) EDETATE DISODIUM (UNII: 7FLD91C86K) XANTHAN GUM (UNII: TTV12P4NEE) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) LINALOOL, (+)- (UNII: F4VNO44C09) .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR) ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B) GERANIOL (UNII: L837108USY) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) BENZYL BENZOATE (UNII: N863NB338G) BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69) PSEUDEVERNIA FURFURACEA (UNII: 49ZMN09Q0K) EUGENOL (UNII: 3T8H1794QW) BENZYL SALICYLATE (UNII: WAO5MNK9TU) LIMONENE, (-)- (UNII: 47MAJ1Y2NE) PHENOXYETHANOL (UNII: HIE492ZZ3T) SORBIC ACID (UNII: X045WJ989B) METHYLPARABEN (UNII: A2I8C7HI9T) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FD&C RED NO. 4 (UNII: X3W0AM1JLX) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68807-320-11 78.4 kg in 1 DRUM; Type 0: Not a Combination Product 01/11/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 01/11/2013 Labeler - Temmentec Ag (480586411) Registrant - Temmentec Ag (480586411) Establishment Name Address ID/FEI Business Operations Temmentec Ag 480586411 manufacture(68807-320)
