Label: SUN PROTECTION BODY SUNSCREEN BROAD SPECTRUM SPF 30 LA PRAIRIE- avobenzone, homosalate, octisalate, oxybenzone lotion
-
Contains inactivated NDC Code(s)
NDC Code(s): 68807-322-11 - 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 25, 2016
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
Active Ingredients Purpose
Avobenzone 3.0% Sunscreen
Homosalate 7.0 % Sunscreen
Octisalate 5.0% Sunscreen
Oxybenzone 5.0% Sunscreen
Uses
helps prevent sunburn
warning
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away
indications
Stop use and ask a doctor if rash occurs.
warnings
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 body
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, Undecrylene Dimethicone, Polyester-8, Polyglyceryl-3 Methylglucose Distearate, Butylene Glycol, Pentylene Glycol, Steareth-21, Glycoproteins, Panax Ginseng Root Extract, Equisetum Arvense (Horsetail) Extract, Sodium Hyaluronate, Octyldodecyl Olivate, Allantoin, Porphyra Umbilicalis Extract, Tocopheryl Acetate, Benzylidene Dimethoxydimethylindanone, Sea Water (Maris Aqua), Diethylhexyl Syringyldenemalonate, Polyacrylamide, Pelvetia Canaliculata Extract, Lecithin, Caprylic/Capric Triglyceride, Palmaria Palmata Extract, Ethylhexylglycerin, Algae Extract, Steareth-2, Disodium EDTA, Hydroxypropyl Starch Phosphate, Alcohol, C13-14 Isoparaffin, Sodium Lactate, Stearyl Alcohol, Dipropylene Glycol, Laureth-7, Fragrance (Parfum), Benzyl Alcohol, Phenoxyethanol, Chlorphenesin, Methylparaben, Propylparaben
- display panel
-
INGREDIENTS AND APPEARANCE
SUN PROTECTION BODY SUNSCREEN BROAD SPECTRUM SPF 30 LA PRAIRIE
avobenzone, homosalate, octisalate, oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68807-322 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3.0 g in 100 kg HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 7.0 g in 100 kg OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5.0 g in 100 kg OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 5.0 g in 100 kg Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) DIMETHICONE (UNII: 92RU3N3Y1O) POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) PENTYLENE GLYCOL (UNII: 50C1307PZG) STEARETH-21 (UNII: 53J3F32P58) ASIAN GINSENG (UNII: CUQ3A77YXI) HYALURONATE SODIUM (UNII: YSE9PPT4TH) ALLANTOIN (UNII: 344S277G0Z) PORPHYRA UMBILICALIS (UNII: 14AN0J70WO) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) BENZYLIDENE DIMETHOXYDIMETHYLINDANONE (UNII: 75HIF3C97L) SODIUM CHLORIDE (UNII: 451W47IQ8X) DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248) POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV) PELVETIA CANALICULATA (UNII: 8U1M44KESN) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) DULSE (UNII: 7832HOY4ZQ) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) STEARETH-2 (UNII: V56DFE46J5) EDETATE DISODIUM (UNII: 7FLD91C86K) ALCOHOL (UNII: 3K9958V90M) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) SODIUM LACTATE (UNII: TU7HW0W0QT) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) DIPROPYLENE GLYCOL (UNII: E107L85C40) LAURETH-7 (UNII: Z95S6G8201) BENZYL ALCOHOL (UNII: LKG8494WBH) PHENOXYETHANOL (UNII: HIE492ZZ3T) CHLORPHENESIN (UNII: I670DAL4SZ) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68807-322-11 78.4 kg in 1 DRUM; Type 0: Not a Combination Product 04/05/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 04/05/2013 Labeler - Temmentec Ag (480586411) Registrant - Temmentec Ag (480586411) Establishment Name Address ID/FEI Business Operations Temmentec Ag 480586411 manufacture(68807-322)