Label: LA MER THE BROAD SPECTRUM SPF 50 UV PROTECTING FLUID- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion
- NDC Code(s): 65966-016-01
- Packager: MAX HUBER RESEARCH LAB INC
- 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 April 25, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
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Uses
- helps prevent sunburn
- if used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun
- Warnings
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Directions
For sunscreen use:
- apply liberally 15 minutes before sun exposure
- reapply every two 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-sleeved shirts, pants, hats and sunglasses
- children under 6 months of age: ask a doctor
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Ingredients
WATER\AQUA\EAU • BUTYLOCTYL SALICYLATE • METHYL TRIMETHICONE • NEOPENTYL GLYCOL DIHEPTANOATE • ALEURITES MOLUCCANA (KUKUI) SEED OIL • LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE • PEG 100 STEARATE • BUTYLENE GLYCOL • GLYCERYL STEARATE • DIPENTAERYTHRITYL TRI-POLYHYDROXYSTEARATE • POTASSIUM CETYL PHOSPHATE • ALGAE (SEAWEED) EXTRACT • SESAMUM INDICUM (SESAME) SEED OIL • MEDICAGO SATIVA (ALFALFA) SEED POWDER • HELIANTHUS ANNUUS (SUNFLOWER) SEEDCAKE • PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) SEED MEAL • EUCALYPTUS GLOBULUS (EUCALYPTUS) LEAF OIL • SODIUM GLUCONATE • COPPER GLUCONATE • CALCIUM GLUCONATE • MAGNESIUM GLUCONATE • ZINC GLUCONATE • TOCOPHERYL SUCCINATE • NIACIN • SESAMUM INDICUM (SESAME) SEED POWDER • LAMINARIA OCHROLEUCA EXTRACT • MALACHITE • CAFFEINE • SORBITOL • SODIUM HYALURONATE • CETYL ALCOHOL • STEARIC ACID • VP/EICOSENE COPOLYMER • ETHYLHEXYLGLYCERIN • SACCHARIDE ISOMERATE • CAPRYLIC/CAPRIC TRIGLYCERIDE • CAPRYLYL GLYCOL • AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER • DEHYDROXANTHAN GUM • SODIUM DEHYDROACETATE • CITRIC ACID • TOURMALINE • STYRENE/ACRYLATES COPOLYMER • SILICA • PEG-8 LAURATE • FRAGRANCE (PARFUM) • DISODIUM EDTA • PHENOXYETHANOL • LIMONENE • GERANIOL • HYDROXYCITRONELLAL • LINALOOL • CITRONELLOL • MICA • GREEN 5 (CI 61570) • TITANIUM DIOXIDE (CI 77891) <ILN40137>
- Other information
- PRINCIPAL DISPLAY PANEL - 50 ml Bottle Carton
-
INGREDIENTS AND APPEARANCE
LA MER THE BROAD SPECTRUM SPF 50 UV PROTECTING FLUID
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65966-016 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 50 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 27 mg in 1 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 30 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) METHYL TRIMETHICONE (UNII: S73ZQI0GXM) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) KUKUI NUT OIL (UNII: TP11QR7B8R) LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) PEG-100 STEARATE (UNII: YD01N1999R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) SESAME OIL (UNII: QX10HYY4QV) ALFALFA SEED (UNII: 67PHZ58858) HELIANTHUS ANNUUS SEEDCAKE (UNII: 482WYF7XLC) EUCALYPTUS OIL (UNII: 2R04ONI662) SODIUM GLUCONATE (UNII: R6Q3791S76) COPPER GLUCONATE (UNII: RV823G6G67) CALCIUM GLUCONATE (UNII: SQE6VB453K) MAGNESIUM GLUCONATE (UNII: T42NAD2KHC) ZINC GLUCONATE (UNII: U6WSN5SQ1Z) .ALPHA.-TOCOPHEROL SUCCINATE, D- (UNII: LU4B53JYVE) NIACIN (UNII: 2679MF687A) SESAME SEED (UNII: 7Y1255HVXR) LAMINARIA OCHROLEUCA (UNII: 4R2124HE76) CAFFEINE (UNII: 3G6A5W338E) SORBITOL (UNII: 506T60A25R) HYALURONATE SODIUM (UNII: YSE9PPT4TH) CETYL ALCOHOL (UNII: 936JST6JCN) STEARIC ACID (UNII: 4ELV7Z65AP) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) SACCHARIDE ISOMERATE (UNII: W8K377W98I) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CAPRYLYL GLYCOL (UNII: 00YIU5438U) AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) PEG-8 LAURATE (UNII: 762O8IWA10) EDETATE DISODIUM (UNII: 7FLD91C86K) PHENOXYETHANOL (UNII: HIE492ZZ3T) GERANIOL (UNII: L837108USY) HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR) LINALOOL, (+/-)- (UNII: D81QY6I88E) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) MICA (UNII: V8A1AW0880) D&C GREEN NO. 5 (UNII: 8J6RDU8L9X) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65966-016-01 1 in 1 CARTON 05/05/2013 1 50 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 05/05/2013 Labeler - MAX HUBER RESEARCH LAB INC (926708694) Registrant - Estee Lauder Companies Inc. (790802086) Establishment Name Address ID/FEI Business Operations PALC 078364654 label(65966-016) , pack(65966-016) Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics Ltd. 204132062 pack(65966-016) , label(65966-016) Establishment Name Address ID/FEI Business Operations Whitman Laboratories Ltd. 216866277 manufacture(65966-016) , pack(65966-016) , label(65966-016) Establishment Name Address ID/FEI Business Operations Estee Lauder N.V. 370151326 manufacture(65966-016) , pack(65966-016) , label(65966-016) Establishment Name Address ID/FEI Business Operations The Estee Lauder Inc 802599436 manufacture(65966-016) , pack(65966-016) , label(65966-016) Establishment Name Address ID/FEI Business Operations Northtec LLC 943871157 pack(65966-016) , label(65966-016) Establishment Name Address ID/FEI Business Operations PADC 1 949264774 pack(65966-016) , label(65966-016)