HAVE A NICE DAY- octinoxate and titanium dioxide cream

HAVE A NICE DAY by

Drug Labeling and Warnings

HAVE A NICE DAY by is a Otc medication manufactured, distributed, or labeled by ORIGINS NATURAL RESOURCES INC., ELGC Kabushiki Kaisha, Estee Lauder Pennsylvania Distribution Center 2 (PADC 2), ARAMIS, INC, ESTEE LAUDER COSMETICS DISTRIBUTION CENTER, ESTEE LAUDER COSMETICS, LTD, ESTEE LAUDER COSMETICS, LTD., ESTEE LAUDER N.V., LEN-RON MANUFACTURING DIVISION OF ARAMIS INC, NORTEC KEYSTONE, NORTHTEC BRISTOL, NORTHTEC KEYSTONE, WHITMAN LABORATORIES, LTD., Aveda Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

octinoxate 7.50% titanium dioxide 1.00%

Ingredients

water\aqua\eau; mentha piperita (peppermint) leaf water, myrtus communis (myrtle) leaf water cyclopentasiloxane butylene glycol peg-100 stearate phenyl trim ethicone myristyl lactate polysorbate 60 tocopheryl acetate dicaprylyl maleate sorbitan palmitate potassium stearate stearyl alcohol betula alba (white birch) extract centella asiatica (hydrocotyl) extract adenosine phosphate citrus limonum medica (lemon) peel oil1, citrus paradisi (grapefruit) peel oil1, mentha viridis (spearmint) leaf oil1, limonene phytosqualane phytosterols hordeum vulgare (barley) extract\extrait d'orge glycine soja (soybean) phospholipid triticum vulgare (wheat) germ extract squalane linoleic acid caffeine magnesium ascorbyl phosphate pantethine tocopherol glyceryl stearate ppg-20 methyl glucose ether aluminum stearate octyldodecyl neopentanoate pentylene glycol glyceryl isostearate potassium carbomer bht disodium edta sodium dehydroacetate phenoxyethanol chlorphenesin <iln33348>

1 essential oil

PURPOSE

Fortifying skin supplements, including firming White Birch Extract and nourishing Soybean, plus potent UV protectors fortify skin with everything it needs to face the day.

WARNING

Keep out of eyes.

Stop use if irritation occurs.

Keep out of reach of children.

SPL UNCLASSIFIED SECTION

©Origins Nat. Res., Dist. NY, NY 10022

PRINCIPAL DISPLAY PANEL - 50 ml Jar Carton

ORIGINS

Have A Nice Day™

Super-charged moisture cream
SPF 15 Sunscreen

net wt. 1.7 oz./50 ml e

INGREDIENTS AND APPEARANCE

HAVE A NICE DAY   SUPER CHARGED SPF 15
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59427-783
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
octinoxate (UNII: 4Y5P7MUD51) (octinoxate - UNII:4Y5P7MUD51)	octinoxate	7.5 mL  in 100 mL
titanium dioxide (UNII: 15FIX9V2JP) (titanium dioxide - UNII:15FIX9V2JP)	titanium dioxide	1 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
peppermint oil (UNII: AV092KU4JH)
myrtle leaf oil (UNII: 4ZP3Q1OY08)
cyclomethicone 5 (UNII: 0THT5PCI0R)
butylene glycol (UNII: 3XUS85K0RA)
peg-100 stearate (UNII: YD01N1999R)
phenyl trimethicone (UNII: DR0K5NOJ4R)
myristyl lactate (UNII: 1D822OC34X)
polysorbate 60 (UNII: CAL22UVI4M)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
dioctyl maleate (UNII: OD88G8439L)
sorbitan monopalmitate (UNII: 77K6Z421KU)
potassium stearate (UNII: 17V812XK50)
stearyl alcohol (UNII: 2KR89I4H1Y)
betula pubescens bark (UNII: 3R504894L9)
centella asiatica leaf (UNII: 6810070TYD)
adenosine phosphate (UNII: 415SHH325A)
lemon oil (UNII: I9GRO824LL)
grapefruit oil (UNII: YR377U58W9)
spearmint oil (UNII: C3M81465G5)
barley (UNII: 5PWM7YLI7R)
soybean (UNII: L7HT8F1ZOD)
wheat germ (UNII: YR3G369F5A)
squalane (UNII: GW89575KF9)
linoleic acid (UNII: 9KJL21T0QJ)
caffeine (UNII: 3G6A5W338E)
magnesium ascorbyl phosphate (UNII: 0R822556M5)
pantethine (UNII: 7K81IL792L)
tocopherol (UNII: R0ZB2556P8)
glyceryl monostearate (UNII: 230OU9XXE4)
aluminum stearate (UNII: U6XF9NP8HM)
octyldodecyl neopentanoate (UNII: X8725R883T)
pentylene glycol (UNII: 50C1307PZG)
glyceryl isostearate (UNII: HYE7O27HAO)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
edetate disodium (UNII: 7FLD91C86K)
sodium dehydroacetate (UNII: 8W46YN971G)
phenoxyethanol (UNII: HIE492ZZ3T)
chlorphenesin (UNII: I670DAL4SZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59427-783-01	1 in 1 CARTON
1		50 mL in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	01/01/2000

Labeler - ORIGINS NATURAL RESOURCES INC. (611716283)

Establishment
Name	Address	ID/FEI	Business Operations
ELGC Kabushiki Kaisha		712808195	RELABEL, REPACK

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)		828534516	MANUFACTURE, RELABEL, REPACK

Establishment
Name	Address	ID/FEI	Business Operations
ARAMIS, INC		042918826	MANUFACTURE

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS DISTRIBUTION CENTER		208579636	REPACK, RELABEL

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		253616536	MANUFACTURE

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		205952385	MANUFACTURE

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE

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

Establishment
Name	Address	ID/FEI	Business Operations
NORTEC KEYSTONE		787336577	MANUFACTURE, RELABEL, REPACK

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC BRISTOL		949264774	MANUFACTURE, RELABEL, REPACK

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC KEYSTONE		618107429	MANUFACTURE, RELABEL, REPACK

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE

Establishment
Name	Address	ID/FEI	Business Operations
Aveda Corporation		071352058	MANUFACTURE