Label: WHITE CAVIAR ILLUMINATING HAND SUNSCREEN BROAD SPECTRUM SPF 15 LA PRAIRIE- avobenzone, homosalate, octinoxate, octisalate, octocrylene cream
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Contains inactivated NDC Code(s)
NDC Code(s): 68807-315-11 - 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
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- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
Active Ingredients Purpose
Avobenzone 3.0% Sunscreen
Homosalate 5.0% Sunscreen
Octinoxate 4.0% Sunscreen
Octisalate 3.0% Sunscreen
Octocrylene 1.5% Sunscreen
Uses
helps prevent sunburnKeep 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
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 removeDirections
Apply liberally 15 minutes before sun exposureSmooth on hands front wrists to fingertips
Children under 6 months: Ask a doctor
Reapply at least every 2 hours
Use a 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 broad spectrum SPF of 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 sunglassesWater (Aqua), Butylene Glycol, Glycerin, Phenyl Trimethicone, Cetearyl Alcohol, SD Alcohol 40-B (Alcohol Denat), Triethylhexanoin, PEG-100 Stearate, Glyceryl Stearate, Cyclopentasiloxane, Dimethicone, Alumina, Butyrospermum Parkii (Shea Butter), Glycoproteins, Panax Ginseng Root Extract, Equisetum Arvense (Horsetail) Extract, Caviar Extract, Vegetable Oil, Sea Water (Maris Aqua), Phormidium Persicinium Extract, Sodium Carboxymethyl Beta-Glucan, Hibiscus Abelmoschus Seed Extract, Glycine Soja (Soybean) Sterols, Resveratrol, Lysine HCL, Hexanoyl Dipeptide-3 Norleucine Acetate, Threonine, Nelumbo Nucifera Flower Extract, Oligopeptide-68, Tryptophan, Lepidium Sativumm Sprout Extract, Histidine, Serine, Magnesium Sulfate, Dimethylmethoxy Chromanyl Palmitate, Sodium Phosphate, Folic Acid, Calcium Pantothenate, Leontopodium Alpinium Flower/Leaf Extract, Soluble Collagen, Carnosine, Synthetic Wax, Glycine, Arginine, Hydroxyethyl Behenamidopropyl Dimonium Chloride, Hydrolyzed Keratin, Glycyrrhiza Glabra (Licorice) Root Extract, Sodium Chloride, Lecithin, Polyquaternium-67, Sodium Stearoyl Lactylate, Chitosan, Sodium Chondroitin Sulfate, Glucose, Ethylhexylglycerin, Disodium EDTA, Sodium Hydroxide, Tocopheryl Acetate, Sodium Lactate, Potassium Sorbate, Cyclohexasiloxane, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Ascorbyl Glucoside, Cetyl Alcohol, Potassium Chloride, Calcium Chloride, Panthenol, Sodium Oleate, Ceteareth-20, Sodium Acrylates Copolymer, Xanthan Gum, Hydrogenated Lecithin, Sodium Citrate, Propylene Glycol, Butyl Stearate, Fragrance/Parfum, Linalool, citronellol, Geraniol, Limonene, Benzyl Benzoate, Benzyl Slicylate, Eugenol, Farnesol, Phenoxyethanol, Sodium Benzoate, Methylparaben, Ethylparaben, Propylparaben, Butylparaben, Isobutylparaben.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
WHITE CAVIAR ILLUMINATING HAND SUNSCREEN BROAD SPECTRUM SPF 15 LA PRAIRIE
avobenzone, homosalate, octinoxate, octisalate, octocrylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68807-315 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 kg HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 5 g in 100 kg OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 4 g in 100 kg OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 3 g in 100 kg OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 1.5 g in 100 kg Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERIN (UNII: PDC6A3C0OX) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K) PEG-100 STEARATE (UNII: YD01N1999R) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DIMETHICONE (UNII: 92RU3N3Y1O) ALUMINUM OXIDE (UNII: LMI26O6933) SHEA BUTTER (UNII: K49155WL9Y) ASIAN GINSENG (UNII: CUQ3A77YXI) EQUISETUM ARVENSE TOP (UNII: 1DP6Y6B65Z) CAVIAR, UNSPECIFIED (UNII: 020K6HLU0O) SODIUM CHLORIDE (UNII: 451W47IQ8X) PHORMIDIUM PERSICINUM (UNII: ZA983U4810) ABELMOSCHUS MOSCHATUS SEED (UNII: UN2QZ55I88) RESVERATROL (UNII: Q369O8926L) LYSINE HYDROCHLORIDE (UNII: JNJ23Q2COM) THREONINE (UNII: 2ZD004190S) NELUMBO NUCIFERA FLOWER (UNII: 61W322NLDV) TRYPTOPHAN (UNII: 8DUH1N11BX) GARDEN CRESS SPROUT (UNII: PWQ18YNR62) HISTIDINE (UNII: 4QD397987E) SERINE (UNII: 452VLY9402) MAGNESIUM SULFATE (UNII: DE08037SAB) SODIUM PHOSPHATE (UNII: SE337SVY37) FOLIC ACID (UNII: 935E97BOY8) CALCIUM PANTOTHENATE (UNII: 568ET80C3D) LEONTOPODIUM ALPINUM FLOWERING TOP (UNII: QQC1AK06RK) CARNOSINE (UNII: 8HO6PVN24W) SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099) GLYCINE (UNII: TE7660XO1C) ARGININE (UNII: 94ZLA3W45F) HYDROXYETHYL BEHENAMIDOPROPYL DIMONIUM CHLORIDE (UNII: 9CO8OUL4TH) LICORICE (UNII: 61ZBX54883) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN) SODIUM CHONDROITIN SULFATE (PORCINE; 5500 MW) (UNII: H5BJH23Z9A) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) EDETATE DISODIUM (UNII: 7FLD91C86K) SODIUM HYDROXIDE (UNII: 55X04QC32I) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) SODIUM LACTATE (UNII: TU7HW0W0QT) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) CYCLOMETHICONE 6 (UNII: XHK3U310BA) CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L) ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW) CETYL ALCOHOL (UNII: 936JST6JCN) POTASSIUM CHLORIDE (UNII: 660YQ98I10) CALCIUM CHLORIDE (UNII: M4I0D6VV5M) PANTHENOL (UNII: WV9CM0O67Z) SODIUM OLEATE (UNII: 399SL044HN) XANTHAN GUM (UNII: TTV12P4NEE) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) SODIUM CITRATE (UNII: 1Q73Q2JULR) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) BUTYL STEARATE (UNII: 6Y0AI5605C) LINALOOL, (+)- (UNII: F4VNO44C09) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) GERANIOL (UNII: L837108USY) LIMONENE, (+)- (UNII: GFD7C86Q1W) BENZYL BENZOATE (UNII: N863NB338G) BENZYL SALICYLATE (UNII: WAO5MNK9TU) EUGENOL (UNII: 3T8H1794QW) FARNESOL (UNII: EB41QIU6JL) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM BENZOATE (UNII: OJ245FE5EU) METHYLPARABEN (UNII: A2I8C7HI9T) ETHYLPARABEN (UNII: 14255EXE39) PROPYLPARABEN (UNII: Z8IX2SC1OH) BUTYLPARABEN (UNII: 3QPI1U3FV8) ISOBUTYLPARABEN (UNII: 0QQJ25X58G) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68807-315-11 78.4 kg in 1 DRUM; Type 0: Not a Combination Product 03/01/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 03/01/2013 Labeler - Temmentec AG (480586411) Registrant - Temmentec AG (480586411) Establishment Name Address ID/FEI Business Operations Temmentec AG 480586411 manufacture(68807-315)
