Label: SUN PROTECTION EMULSION FACE BROAD SPECTRUM SPF 30 LA PRAIRIE GROUP- avobenzone, homosalate, octisalate, octocrylene, oxybenzone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 68807-307-01, 68807-307-02 - 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 18, 2016
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- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
Active ingredients Purpose
Avobenzone 3.0% Sunscreen
Homosalate 10.0% Sunscreen
Octisalate 2.6% Sunscreen
Octocrylene 2.4% Sunscreen
Oxybenzone 5.0% 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
Inactive Ingredients
Water (Aqua), Caprylyl Methicone, Hexyldecanol, Dimethicone, Polyglyceryl-3 Methylglucose Distearate, Undercrylene Dimethicone, Aluminum Starch Octenylsuccinate, Steareth-21, Octyldodecyl Olivate, Cetyl Alcohol, Silica, Glycerin, Glycoproteins, Panax Ginseng Root Extract, Equisetum Arvense (Horsetail) Extract, Sodium Hyalu-ronate, Corallina Officinalis Extract, Sea Water (Maris Aqua), Algae Extract, Aloe Barbadensis Leaf Juice, Steareth-2, Ethylhexyl Glycerin, Disodium EDTA, Benzylidene Dime- thoxydimethylindanone, Sodium Hydroxide, Porphyra Umbilicalis Extract, Squalane, Carbomer, Potassium Sorbate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Palmaria Palmata Extract, Tocopheryl Acetate, Diethylhexyl Syringyldenemalonate, Pelvetia Canaliculata Extract, Polysorbate 60, Lecithin, Caprylic/Capric Triglyceride, Sodium Lactate, Caprylyl Glycol, Alcohol, Benzyl Alcohol, Fragrance (Parfum), Phenoxyethanol, Chlorphenesin, Sodium Benzoate, Methylparaben, Ethylparaben, Propylparaben.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SUN PROTECTION EMULSION FACE BROAD SPECTRUM SPF 30 LA PRAIRIE GROUP
avobenzone, homosalate, octisalate, octocrylene, oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68807-307 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 10 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 2.6 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 2.4 g in 100 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 5 g in 100 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) HEXYLDECANOL (UNII: 151Z7P1317) DIMETHICONE (UNII: 92RU3N3Y1O) STEARETH-21 (UNII: 53J3F32P58) CETYL ALCOHOL (UNII: 936JST6JCN) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) GLYCERIN (UNII: PDC6A3C0OX) ASIAN GINSENG (UNII: CUQ3A77YXI) HYALURONATE SODIUM (UNII: YSE9PPT4TH) CORALLINA OFFICINALIS (UNII: 4004498D06) SODIUM CHLORIDE (UNII: 451W47IQ8X) ALOE VERA LEAF (UNII: ZY81Z83H0X) STEARETH-2 (UNII: V56DFE46J5) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) EDETATE DISODIUM (UNII: 7FLD91C86K) BENZYLIDENE DIMETHOXYDIMETHYLINDANONE (UNII: 75HIF3C97L) SODIUM HYDROXIDE (UNII: 55X04QC32I) SQUALANE (UNII: GW89575KF9) CARBOMER 934 (UNII: Z135WT9208) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4) DULSE (UNII: 7832HOY4ZQ) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248) PELVETIA CANALICULATA (UNII: 8U1M44KESN) POLYSORBATE 60 (UNII: CAL22UVI4M) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) SODIUM LACTATE (UNII: TU7HW0W0QT) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ALCOHOL (UNII: 3K9958V90M) BENZYL ALCOHOL (UNII: LKG8494WBH) PHENOXYETHANOL (UNII: HIE492ZZ3T) CHLORPHENESIN (UNII: I670DAL4SZ) SODIUM BENZOATE (UNII: OJ245FE5EU) METHYLPARABEN (UNII: A2I8C7HI9T) ETHYLPARABEN (UNII: 14255EXE39) PROPYLPARABEN (UNII: Z8IX2SC1OH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68807-307-02 1 in 1 CARTON 1 NDC:68807-307-01 125 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 02/14/2011 Labeler - Temmentec Ag (480586411) Registrant - Temmentec Ag (480586411) Establishment Name Address ID/FEI Business Operations Temmentec Ag 480586411 manufacture(68807-307)
