Drug Facts

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 oil 1, pelargonium 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, 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

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

DR ANDREW WEILS FOR ORIGINS MEGA-DEFENSE ADVANCED DAILY UV DEFENDER BROAD SPECTRUM SPF 45
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	63 mg in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	40 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, COLD PRESSED (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 Drug	M020	02/15/2016

Labeler - ORIGINS NATURAL RESOURCES INC. (611716283)

Registrant - Estee Lauder Companies Inc. (790802086)

Name	Address	ID/FEI	Business Operations
Establishment
The Estee Lauder Inc		802599436	manufacture(59427-113) , pack(59427-113) , label(59427-113)