DR WEILS MEGA-DEFENSE ADVANCED DAILY UV DEFENDER BROAD SPECTRUM SPF 45 SUNCREEN- titanium dioxide and zinc oxide lotion

DR ANDREW WEILS FOR ORIGINS by

Drug Labeling and Warnings

DR ANDREW WEILS FOR ORIGINS by is a Otc medication manufactured, distributed, or labeled by ORIGINS NATURAL RESOURCES INC., Estee Lauder Companies Inc., PALC, Estee Lauder Cosmetics Ltd., Northtec LLC, PADC 1, The Estee Lauder Inc, Whitman Laboratories Ltd., Estee Lauder N.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts
ACTIVE INGREDIENT

Active ingredients Purpose

titanium dioxide 6.3% Sunscreen

zinc oxide 4.0% Sunscreen
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

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.

Stop use and ask a doctor if rash occurs

Keep out of reach of children.
If product is swallowed, get medical help or contact a Poison Control Center right away.
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
- 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
Inactive ingredients

water\aqua\eau dimethicone butyloctyl salicylate c12-15 alkyl benzoate methyl trimethicone isononyl isononanoate diethylhexyl succinate neopentyl glycol diheptanoate butylene glycol dipentaerythrityl tri-polyhydroxystearate lauryl peg-9 polydimethylsiloxyethyl dimethicone silica citrus aurantium dulcis(orange) peel oil1, pelargonium odorata flower oil1, eugenia caryophyllus (clove) bud oil1, rosa damascena flower oil1, jasminum officinale (jasmine) oil1, viola odorata flower/leaf extract, polianthes tuberosa extract, geraniol, benzyl benzoate, citronellol, eugenol epilobium angustifolium flower\leaf\stem extract hordeum vulgare (barley) extract\extrait d'orge triticum vulgare (wheat) germ extract vaccinium angustifolium (blueberry) fruit extract vaccinium macrocarpon (cranberry) fruit extract lycium chinense (wolfberry) fruit extract rosa roxburghii fruit extract opuntia tuna extract trimethylsiloxysilicate hydroxyapatite cetyl peg/ppg-10/1 dimethicone glycerin scutellaria baicalensis root extract squalane yeast extract\faex\extrait de levure dimethicone/peg-10/15 crosspolymer dimethicone silylate tocopheryl acetate hydrolyzed wheat protein/pvp crosspolymer dimethicone crosspolymer-3 isostearic acid caprylyl glycol polyhydroxystearic acid bht phenoxyethanol <iln41804>

1 essential oil

Active ingredients	Purpose
titanium dioxide 6.3%	Sunscreen
zinc oxide 4.0%	Sunscreen

Other information

protect the product in this container from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton

Dr. Andrew
WEIL for Origins™

Mega-Defense
SPF 45
Advanced Daily
UV Defender
Broad Spectrum SPF 45

1 fl. oz./oz. liq./30 ml e

Principal Display Panel - 30 ml Bottle Carton

INGREDIENTS AND APPEARANCE

DR WEILS MEGA-DEFENSE ADVANCED DAILY UV DEFENDER BROAD SPECTRUM SPF 45 SUNCREEN
titanium dioxide and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59427-113
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	66.78 mg in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	14.96 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIPENTAERYTHRITYL TRI-POLYHYDROXYSTEARATE (UNII: D21K655H52)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ORANGE OIL (UNII: AKN3KSD11B)
CLOVE OIL (UNII: 578389D6D0)
ROSA X DAMASCENA FLOWER OIL (UNII: 18920M3T13)
JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)
VIOLA ODORATA FLOWERING TOP (UNII: 04BPC87I4H)
GERANIOL (UNII: L837108USY)
BENZYL BENZOATE (UNII: N863NB338G)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
EUGENOL (UNII: 3T8H1794QW)
EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP (UNII: 08H094218D)
BARLEY (UNII: 5PWM7YLI7R)
WHEAT GERM (UNII: YR3G369F5A)
LOWBUSH BLUEBERRY (UNII: G90PX41VP0)
CRANBERRY (UNII: 0MVO31Q3QS)
LYCIUM CHINENSE FRUIT (UNII: TG711Q7A1Q)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)
GLYCERIN (UNII: PDC6A3C0OX)
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
SQUALANE (UNII: GW89575KF9)
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ISOSTEARIC ACID (UNII: X33R8U0062)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 59427-113-01	1 in 1 CARTON	02/15/2016
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	02/15/2016

Labeler - ORIGINS NATURAL RESOURCES INC. (611716283)

Name	Address	ID/FEI	Business Operations
Establishment
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(59427-113) , REPACK(59427-113)

Name	Address	ID/FEI	Business Operations
Establishment
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(59427-113)

Name	Address	ID/FEI	Business Operations
Establishment
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(59427-113)

Name	Address	ID/FEI	Business Operations
Establishment
ESTEE LAUDER N.V		370151326	MANUFACTURE(59427-113)

Name	Address	ID/FEI	Business Operations
Establishment
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(59427-113)

Name	Address	ID/FEI	Business Operations
Establishment
NORTHTEC INC		943871157	RELABEL(59427-113) , REPACK(59427-113)

Name	Address	ID/FEI	Business Operations
Establishment
PADC 1		949264774	RELABEL(59427-113) , REPACK(59427-113)

Name	Address	ID/FEI	Business Operations
Establishment
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(59427-113)

Name	Address	ID/FEI	Business Operations
Establishment
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(59427-113)