YOUTH SURGE SPF 15 AGE DECELERATING MOISTURIZER ANTI RIDES HYDRATANT- octinoxate and titanium dioxide cream

YOUTH SURGE by

Drug Labeling and Warnings

YOUTH SURGE by is a Otc medication manufactured, distributed, or labeled by CLINIQUE LABORATORIES 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]

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Drug Facts

Active ingredients

Octinoxate 7.5%

Titanium dioxide 1.4%

Purpose

Sunscreen

Use

helps prevent sunburn

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 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

Inactive ingredients

water cetyl ethylhexanoate butylene glycol octyldodecyl neopentanoate glyceryl stearate peg-100 stearate glycerin olea europaea (olive) fruit extract coleus barbatus extract sigesbeckia orientalis (st. paul's wort) extract triticum vulgare (wheat bran) extract polygonum cuspidatum root extract saccharomyces lysate extract algae extract hydrolyzed rice extract betula alba (birch) bark extract padina pavonica thallus extract coffea robusta seed extract astrocaryum murumuru seed butter citrus reticulata (tangerine) peel extract laurdimonium hydroxypropyl hydrolyzed soy protein hydrogenated lecithin creatine ethylhexyl palmitate polyethylene pentylene glycol caffeine behenyl alcohol linoleic acid cetyl alcohol isoniacinamide cholesterol lecithin sorbitol trehalose silica sodium rna dipalmitoyl hydroxyproline disodium nadh sodium hyaluronate aminopropyl ascorbyl phosphate methicone caprylyl glycol decarboxy carnosine hcl potassium sulfate adenosine phosphate ethylhexyl stearate glycine phytosphingosine acrylates copolymer propylene glycol dicaprate acetyl hexapeptide-8 hydroxyproline proline xanthan gum alumina sodium dna potassium hydroxide hexylene glycol carbomer disodium edta phenoxyethanol potassium sorbate [iln36979]

Other information

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

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© CLINIQUE LABORATORIES, DIST. NEW YORK, N.Y. 10022

PRINCIPAL DISPLAY PANEL - 50 ml Carton

C
CLINIQUE

youth surge
age decelerating moisturizer
broad spectrum SPF 15

COMBINATION OILY TO OILY

POIDS NET WT. 1.7 OZ./50 ml e

INGREDIENTS AND APPEARANCE

YOUTH SURGE   SPF 15 AGE DECELERATING MOISTURIZER ANTI RIDES HYDRATANT
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49527-731
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	1.4 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
GLYCERIN (UNII: PDC6A3C0OX)
BLACK OLIVE (UNII: 2M6QWV94OC)
PLECTRANTHUS BARBATUS ROOT (UNII: V5741391RG)
WHEAT BRAN (UNII: 6L966A1IMR)
POLYGONUM CUSPIDATUM ROOT (UNII: 7TRV45YZF7)
SACCHAROMYCES LYSATE (UNII: R85W246Z1C)
BETULA PUBESCENS BARK (UNII: 3R504894L9)
PADINA PAVONICA (UNII: 177U06NHZI)
ROBUSTA COFFEE BEAN (UNII: V5032728L7)
ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)
TANGERINE PEEL (UNII: JU3D414057)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
CREATINE (UNII: MU72812GK0)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
CAFFEINE (UNII: 3G6A5W338E)
DOCOSANOL (UNII: 9G1OE216XY)
LINOLEIC ACID (UNII: 9KJL21T0QJ)
CETYL ALCOHOL (UNII: 936JST6JCN)
ISONIACINAMIDE (UNII: 4H3BH6YX9Q)
CHOLESTEROL (UNII: 97C5T2UQ7J)
SORBITOL (UNII: 506T60A25R)
PIMAGEDINE HYDROCHLORIDE (UNII: A2Z7G2RGAH)
TREHALOSE (UNII: B8WCK70T7I)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
AMINOPROPYL ASCORBYL PHOSPHATE (UNII: 290O2PQ83R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
POTASSIUM SULFATE (UNII: 1K573LC5TV)
ADENOSINE PHOSPHATE (UNII: 415SHH325A)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
GLYCINE (UNII: TE7660XO1C)
PROPYLENE GLYCOL DICAPRATE (UNII: U783H9JHWY)
HYDROXYPROLINE (UNII: RMB44WO89X)
PROLINE (UNII: 9DLQ4CIU6V)
XANTHAN GUM (UNII: TTV12P4NEE)
ALUMINUM OXIDE (UNII: LMI26O6933)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49527-731-01	1 in 1 CARTON
1		50 mL in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	02/24/2009

Labeler - CLINIQUE LABORATORIES INC. (173047747)

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