Label: ANTI-AGING DAY BROAD SPECTRUM SPF 30 LA PRAIRIE GROUP AG- avobenzone, octinoxate, octisalate, octocrylene cream
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Contains inactivated NDC Code(s)
NDC Code(s): 68807-316-11 - 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 5, 2017
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- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
Active ingredients purpose
Avobenzone 3.0% Sunscreen
Octinoxate 7.5% Sunscreen
Octisalate 5.0% Sunscreen
Octocrylene 2.5% Sunscreen
Uses
- helps prevent sunburn
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 daily after cleansing and toning
• smooth over face & 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
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:
• Limit time in the sun, especially from 10 a.m. – 2 p.m.
• Wear long-sleeve shirts, pants, hats, and sunglasses
Water (Aqua), C12-15 Alkyl Ethylhexanoate, Glycerin, Dimethicone/Vinyl DimethiconeCrosspolymer, Polyglyceryl-3 Methylglucose Distearate, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Steareth-21, Behenyl Alcohol, Butylene Glycol, Glycoproteins, Panax Ginseng Root Extract, Equisetum Arvense (Horsetail) Extract, Sodium Hyaluronate, Caprooyl Tetrapeptide-3, Salicornia Herbacea Extract, Sodium PCA, Tocopheryl Acetate, Resveratrol, Acetyl Decapeptide-3, Trehalose, Urea, Larix Sibirica Wood Extract, Palmitoyl Tripeptide-8, Carnosine, Potato Starch Modified, Disodium EDTA, Myrothamnus Flabellifolia Leaf/Stem Extract, Kefiran, Sodium Hydroxide, Glyceryl Stearate, Chlorella Vulgaris Extract, Silica, Panthenol, Polyquaternium-51, Glycine Soja (Soybean) Oil, PEG-100 Stearate, Hydrogenated Lecithin, Allantoin, Hydroxyethyl Behenamidopropyl Dimonium Chloride, C13-14 Isoparaffin, Dextran, Caprylic/Capric Triglyceride, Polysorbate 80, Sodium Oleate, Laureth-7, Cetyl Dimethicone, Caprylyl Glycol, Polyquaternium-67, Steareth-2, Polyacrylamide, Carbomer, Synthetic Wax, Alcohol, 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, Chlorphenesin, Methylparaben, Benzoic Acid, Yellow 5 (CI 19140), Red 4 (CI 14700)
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ANTI-AGING DAY BROAD SPECTRUM SPF 30 LA PRAIRIE GROUP AG
avobenzone, octinoxate, octisalate, octocrylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68807-316 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 OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g in 100 kg OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 kg OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 2.5 g in 100 kg Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) STEARETH-21 (UNII: 53J3F32P58) DOCOSANOL (UNII: 9G1OE216XY) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) ASIAN GINSENG (UNII: CUQ3A77YXI) HYALURONATE SODIUM (UNII: YSE9PPT4TH) SALICORNIA EUROPAEA (UNII: 6ADL50JAKW) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) RESVERATROL (UNII: Q369O8926L) TREHALOSE (UNII: B8WCK70T7I) UREA (UNII: 8W8T17847W) LARIX SIBIRICA WOOD (UNII: KSC3PGF73L) CARNOSINE (UNII: 8HO6PVN24W) EDETATE DISODIUM (UNII: 7FLD91C86K) MYROTHAMNUS FLABELLIFOLIA LEAF (UNII: 6Y9E0R40J5) SODIUM HYDROXIDE (UNII: 55X04QC32I) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) CHLORELLA VULGARIS (UNII: RYQ4R60M02) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) PANTHENOL (UNII: WV9CM0O67Z) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) SOYBEAN OIL (UNII: 241ATL177A) PEG-100 STEARATE (UNII: YD01N1999R) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) ALLANTOIN (UNII: 344S277G0Z) HYDROXYETHYL BEHENAMIDOPROPYL DIMONIUM CHLORIDE (UNII: 9CO8OUL4TH) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SODIUM OLEATE (UNII: 399SL044HN) LAURETH-7 (UNII: Z95S6G8201) CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB) CAPRYLYL GLYCOL (UNII: 00YIU5438U) STEARETH-2 (UNII: V56DFE46J5) POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV) CARBOMER 934 (UNII: Z135WT9208) SYNTHETIC WAX (1800 MW) (UNII: 248P1AUJ90) ALCOHOL (UNII: 3K9958V90M) LINALOOL, (+/-)- (UNII: D81QY6I88E) .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: GFD7C86Q1W) PHENOXYETHANOL (UNII: HIE492ZZ3T) SORBIC ACID (UNII: X045WJ989B) CHLORPHENESIN (UNII: I670DAL4SZ) METHYLPARABEN (UNII: A2I8C7HI9T) BENZOIC ACID (UNII: 8SKN0B0MIM) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) FD&C RED NO. 4 (UNII: X3W0AM1JLX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68807-316-11 78.4 kg in 1 DRUM; Type 0: Not a Combination Product 01/16/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 01/16/2013 Labeler - Temmentec AG (480586411) Registrant - Temmentec AG (480586411) Establishment Name Address ID/FEI Business Operations Temmentec AG 480586411 manufacture(68807-316)