![LA MER THE REPARATIVE BODY SUN BROAD SPECTRUM SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [MAX HUBER RESEARCH LAB INC]](https://medic.hrt.org//dailymed/images/00bbdaa3-b364-4bc3-b85a-6d6621df0896/la-mer-01.jpg)
| NDC | 65966-014-01 |
| Set ID | 00bbdaa3-b364-4bc3-b85a-6d6621df0896 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | MAX HUBER RESEARCH LAB INC |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
- 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 at least 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 • neopentyl glycol diheptanoate • butyrospermum parkii (shea butter) • lauryl peg-9 polydimethylsiloxyethyl dimethicone • peg-100 stearate • butylene glycol • glyceryl stearate • methyl trimethicone • dipentaerythrityl tri-polyhydroxystearate • dimethicone • stearic acid • 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 • rosmarinus officinalis (rosemary) extract • citrus aurantifolia (lime) peel extract • cucumis sativus (cucumber) fruit extract • pyrus malus (apple) fruit extract • scutellaria baicalensis root extract • plankton extract • thermus thermophillus ferment • laurdimonium hydroxypropyl hydrolyzed soy protein • acetyl hexapeptide-8 • caffeine • arginine ferulate • lecithin • cholesterol • yeast extract\faex\extrait de levure • sucrose • sorbitol • trehalose • phytosphingosine • polyquaternium-51 • phenyl trimethicone • cetyl alcohol • vp/eicosene copolymer • glycerin • polysilicone-11 • caprylyl glycol • ethylhexylglycerin • saccharide isomerate • caprylic/capric triglyceride • ammonium acryloyldimethyltaurate /vp copolymer • sodium pca • sodium hyaluronate • urea • dehydroxanthan gum • tocopheryl acetate • citric acid • styrene/acrylates copolymer • xanthan gum • peg-8 laurate • ascorbyl tocopheryl maleate • malachite • tourmaline • nordihydroguaiaretic acid • fragrance (parfum) • hexylene glycol • alcohol denat. • disodium edta • sodium dehydroacetate • phenoxyethanol • hydroxycitronellal • linalool • hexyl cinnamal • amyl cinnamal • benzyl benzoate • coumarin • limonene • citronellol • geraniol • citral • mica <iln39608>
- Other information
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 200 ml Tube Carton
-
INGREDIENTS AND APPEARANCE
LA MER THE REPARATIVE BODY SUN BROAD SPECTRUM SPF 30
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65966-014 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 0.0312 g in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 0.052 g in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 0.052 g in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 0.02808 g in 1 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0312 g in 1 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) butyloctyl salicylate (UNII: 2EH13UN8D3) neopentyl glycol diheptanoate (UNII: 5LKW3C543X) shea butter (UNII: K49155WL9Y) peg-100 stearate (UNII: YD01N1999R) butylene glycol (UNII: 3XUS85K0RA) glyceryl monostearate (UNII: 230OU9XXE4) methyl trimethicone (UNII: S73ZQI0GXM) dimethicone (UNII: 92RU3N3Y1O) stearic acid (UNII: 4ELV7Z65AP) 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) rosemary (UNII: IJ67X351P9) lime peel (UNII: 544EQK5Q0W) cucumber (UNII: YY7C30VXJT) apple (UNII: B423VGH5S9) scutellaria baicalensis root (UNII: 7J95K7ID2S) thermus thermophilus lysate (UNII: 775R692494) acetyl hexapeptide-8 (UNII: L4EL31FWIL) caffeine (UNII: 3G6A5W338E) cholesterol (UNII: 97C5T2UQ7J) yeast, unspecified (UNII: 3NY3SM6B8U) sucrose (UNII: C151H8M554) sorbitol (UNII: 506T60A25R) trehalose (UNII: B8WCK70T7I) phytosphingosine (UNII: GIN46U9Q2Q) phenyl trimethicone (UNII: DR0K5NOJ4R) cetyl alcohol (UNII: 936JST6JCN) glycerin (UNII: PDC6A3C0OX) caprylyl glycol (UNII: 00YIU5438U) ethylhexylglycerin (UNII: 147D247K3P) saccharide isomerate (UNII: W8K377W98I) medium-chain triglycerides (UNII: C9H2L21V7U) ammonium acryloyldimethyltaurate/vp copolymer (UNII: W59H9296ZG) sodium pyrrolidone carboxylate (UNII: 469OTG57A2) hyaluronate sodium (UNII: YSE9PPT4TH) urea (UNII: 8W8T17847W) .alpha.-tocopherol acetate (UNII: 9E8X80D2L0) citric acid monohydrate (UNII: 2968PHW8QP) xanthan gum (UNII: TTV12P4NEE) peg-8 laurate (UNII: 762O8IWA10) ascorbyl tocopheryl maleate (UNII: D2G6259XR5) masoprocol (UNII: 7BO8G1BYQU) hexylene glycol (UNII: KEH0A3F75J) edetate sodium (UNII: MP1J8420LU) sodium dehydroacetate (UNII: 8W46YN971G) phenoxyethanol (UNII: HIE492ZZ3T) hydroxycitronellal (UNII: 8SQ0VA4YUR) linalool, (+/-)- (UNII: D81QY6I88E) .alpha.-hexylcinnamaldehyde (UNII: 7X6O37OK2I) .alpha.-amylcinnamaldehyde (UNII: WC51CA3418) benzyl benzoate (UNII: N863NB338G) coumarin (UNII: A4VZ22K1WT) .beta.-citronellol, (r)- (UNII: P01OUT964K) geraniol (UNII: L837108USY) citral (UNII: T7EU0O9VPP) mica (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65966-014-01 1 in 1 CARTON 01/01/2013 1 200 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 NOT FINAL part352 01/01/2013 Labeler - MAX HUBER RESEARCH LAB INC (926708694) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COMPANY, THE 828534516 RELABEL(65966-014) , REPACK(65966-014) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 244669714 MANUFACTURE(65966-014) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD. 202952982 MANUFACTURE(65966-014) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER N.V. 370151326 MANUFACTURE(65966-014) Establishment Name Address ID/FEI Business Operations LEN-RON MANUFACTURING DIVISION OF ARAMIS INC 809771152 MANUFACTURE(65966-014) Establishment Name Address ID/FEI Business Operations NORTHTEC INC 943871157 RELABEL(65966-014) , REPACK(65966-014) Establishment Name Address ID/FEI Business Operations PADC 1 949264774 RELABEL(65966-014) , REPACK(65966-014) Establishment Name Address ID/FEI Business Operations WHITMAN LABORATORIES, LTD. 216866277 MANUFACTURE(65966-014) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 255175580 MANUFACTURE(65966-014)
