Label: DR. ANDREW WEIL FOR ORIGINS MEGA-BRIGHT SPF 30 SKIN TONE CORRECTING OIL FREE MOISTURIZER BROAD SPECTRUM SPF 30- homosalate, octisalate, avobenzone, and octocrylene cream
- NDC Code(s): 59427-112-01
- Packager: ORIGINS NATURAL RESOURCES 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 September 11, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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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 generously and evenly 15 minutes before sun exposure
- reapply at least every two hours
- use a water resistant sunscreen if swimming or sweating
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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 10am – 2pm
- 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 • behenyl alcohol • nylon-12 • octyldodecyl neopentanoate • dimethicone • butylene glycol • myristyl myristate • cetyl esters • ascorbyl glucoside • polyethylene • ammonium acryloyldimethyltaurate/vp copolymer • citrus aurantium dulcis (orange) peel oil 1, pelargonium graveolens flower oil 1, cananga odorata flower oil 1, eugenia caryophyllus (clove) bud oil 1, rosa damascena flower oil 1, jasminum officinale (jasmine) oil 1, viola odorata flower/leaf extract, polianthes tuberosa extract, farnesol, eugenol, benzyl salicylate, citronellol, citral, benzyl benzoate, geraniol • rosa roxburghii fruit extract • paeonia albiflora (peony) root extract • molasses extract\saccharum officinarum\extrait de mélasse • citrus grandis (grapefruit) peel extract • triticum vulgare (wheat) germ extract • hordeum vulgare (barley) extract\extrait d'orge • palmaria palmata extract • punica granatum (pomegranate) fruit juice • hydrolyzed rice bran extract • gentiana lutea (gentian) root extract • curcuma longa (turmeric) root extract • sucrose 2 • glyceryl stearate • peg-100 stearate • peg-6 • glycerin • linoleic acid • salicylic acid • di-ppg-2 myreth-10 adipate • sodium hyaluronate • betaine • dipotassium glycyrrhizate • steareth-21 • trehalose • tocopheryl acetate • myristyl laurate • trisiloxane • di-c12-18 alkyl dimonium chloride • caprylyl glycol • squalane • myristyl alcohol • tromethamine • sodium dehydroacetate • hexylene glycol • sodium hydroxide • phenoxyethanol • mica <iln44031>
- Other information
- PRINCIPAL DISPLAY PANEL - 50 ml Jar Carton
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INGREDIENTS AND APPEARANCE
DR. ANDREW WEIL FOR ORIGINS MEGA-BRIGHT SPF 30 SKIN TONE CORRECTING OIL FREE MOISTURIZER BROAD SPECTRUM SPF 30
homosalate, octisalate, avobenzone, and octocrylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59427-112 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 50 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 27 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) DOCOSANOL (UNII: 9G1OE216XY) NYLON-12 (UNII: 446U8J075B) OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) DIMETHICONE (UNII: 92RU3N3Y1O) MYRISTYL MYRISTATE (UNII: 4042ZC00DY) CETYL ESTERS WAX (UNII: D072FFP9GU) ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) ORANGE OIL, COLD PRESSED (UNII: AKN3KSD11B) PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC) YLANG-YLANG OIL (UNII: 8YOY78GNNX) CLOVE OIL (UNII: 578389D6D0) ROSA X DAMASCENA FLOWER OIL (UNII: 18920M3T13) JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432) VIOLA ODORATA FLOWERING TOP (UNII: 04BPC87I4H) FARNESOL (UNII: EB41QIU6JL) EUGENOL (UNII: 3T8H1794QW) BENZYL SALICYLATE (UNII: WAO5MNK9TU) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) CITRAL (UNII: T7EU0O9VPP) BENZYL BENZOATE (UNII: N863NB338G) GERANIOL (UNII: L837108USY) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P) MOLASSES (UNII: LSU3YX0KZO) CITRUS MAXIMA FRUIT RIND (UNII: 5NX3G75CA6) WHEAT GERM (UNII: YR3G369F5A) BARLEY (UNII: 5PWM7YLI7R) PALMARIA PALMATA (UNII: 7832HOY4ZQ) POMEGRANATE JUICE (UNII: 99S671U9KB) RICE BRAN (UNII: R60QEP13IC) GENTIANA LUTEA ROOT (UNII: S72O3284MS) TURMERIC (UNII: 856YO1Z64F) SUCROSE (UNII: C151H8M554) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) PEG-6 STEARATE (UNII: 8LQC57C6B0) GLYCERIN (UNII: PDC6A3C0OX) LINOLEIC ACID (UNII: 9KJL21T0QJ) SALICYLIC ACID (UNII: O414PZ4LPZ) DI-PPG-2 MYRETH-10 ADIPATE (UNII: 4IN301M0KJ) HYALURONATE SODIUM (UNII: YSE9PPT4TH) BETAINE (UNII: 3SCV180C9W) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) STEARETH-21 (UNII: 53J3F32P58) TREHALOSE (UNII: B8WCK70T7I) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) MYRISTYL LAURATE (UNII: 58U0NZN2BT) TRISILOXANE (UNII: 9G1ZW13R0G) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SQUALANE (UNII: GW89575KF9) MYRISTYL ALCOHOL (UNII: V42034O9PU) TROMETHAMINE (UNII: 023C2WHX2V) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) HEXYLENE GLYCOL (UNII: KEH0A3F75J) SODIUM HYDROXIDE (UNII: 55X04QC32I) PHENOXYETHANOL (UNII: HIE492ZZ3T) MICA (UNII: V8A1AW0880) N-DIALKYL METHYL BENZYL AMMONIUM CHLORIDE (C12-C18) (UNII: 00MFZ4H95Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59427-112-01 1 in 1 CARTON 11/01/2013 1 50 mL in 1 JAR; 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 11/01/2013 Labeler - ORIGINS NATURAL RESOURCES INC. (611716283) Registrant - Estee Lauder Companies Inc. (790802086) Establishment Name Address ID/FEI Business Operations The Estee Lauder Inc 802599436 manufacture(59427-112) , pack(59427-112) , label(59427-112)
