MOISTURE SURGE SPF- avobenzone,homosalate,octinoxate,octisalate cream

MOISTURE SURGE SPF by

Drug Labeling and Warnings

MOISTURE SURGE SPF by is a Otc medication manufactured, distributed, or labeled by CLINIQUE LABORATORIES LLC, Estee Lauder Companies Inc., LE PAPILLON, LTD., PALC, Estee Lauder Cosmetics Ltd., Whitman Laboratories Ltd., Estee Lauder N.V., NORTHTEC LLC, PADC 1, The Estee Lauder Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

Avobenzone 3.0%
Homosalate 7.0%
Octinoxate 7.0%
Octisalate 4.5%

PURPOSE

SUNSCREEN

USE

helps prevent sunburn

WARNINGS

WARNINGS

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 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 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\aqua\eau · butylene glycol · ethylhexyl methoxycrylene ·butyloctyl salicylate · dextrin palmitate · polymethylsilsesquioxane ·
glycerin · lactobacillus ferment lysate · aloe barbadensis leaf polysaccharides · sodium hyaluronate · caffeine · sodium
polyaspartate · 7-dehydrocholesterol · caprylyl glycol · acrylates copolymer · sorbitol · dimethicone · polyglyceryl-2 stearate · sucrose ·
saccharide isomerate · hydroxyethyl urea · ppg-8-ceteth-20 · sorbeth-30 tetraisostearate · glyceryl stearate · sorbitan
sesquiisostearate · potassium hydroxide · carbomer · dipropyleneglycol · dehydroxanthan gum · stearyl alcohol · sodium
polyacryloyldimethyl taurate · hexylene glycol · acrylates/beheneth-25 methacrylate copolymer · acrylates/c10-30 alkyl
acrylate crosspolymer · tocopheryl acetate · bht · disodium edta ·sodium citrate · citric acid · potassium sorbate · sodium
benzoate · phenoxyethanol · red 4 (ci 14700) [iln50856]

OTHER INFORMAITON

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

PRINCIPAL DISPLAY PANEL

CLINIQUE
moisture surge
broad spectrum SPF 28
sheer hydrator
ALOE BIOFERMENT + PRO-VIT D
POIDS NET WT. 1.7 OZ./50 ml e

INGREDIENTS AND APPEARANCE

MOISTURE SURGE SPF 
avobenzone,homosalate,octinoxate,octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49527-084
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	70 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	70 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	45 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF POLYSACCHARIDES (UNII: W21O437517)
7-DEHYDROCHOLESTEROL (UNII: BK1IU07GKF)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SORBITOL (UNII: 506T60A25R)
POLYGLYCERYL-2 STEARATE (UNII: 253MC0P0YV)
DISODIUM ASPARTATE (UNII: 48MC6MXP9X)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
DEHYDROXANTHAN GUM (UNII: 63ZP7I1BQO)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
DIMETHICONE (UNII: 92RU3N3Y1O)
SODIUM BENZOATE (UNII: OJ245FE5EU)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
SUCROSE (UNII: C151H8M554)
PPG-8-CETETH-20 (UNII: MAL0SND89Q)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CAFFEINE (UNII: 3G6A5W338E)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
LIMOSILACTOBACILLUS FERMENTUM (UNII: 2C1F12C6AP)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49527-084-01	1 in 1 CARTON	11/30/2022
1		50 mL in 1 JAR; Type 0: Not a Combination Product
2	NDC: 49527-084-02	1 in 1 CARTON	11/30/2022
2		30 mL in 1 JAR; Type 0: Not a Combination Product
3	NDC: 49527-084-03	1 in 1 CARTON	11/30/2022
3		5 mL in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 49527-084-04	1 mL in 1 PACKAGE; Type 0: Not a Combination Product	11/30/2022	12/31/2023
5	NDC: 49527-084-05	1 in 1 CARTON	11/07/2022
5		75 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 Drug	M020	11/07/2022

Labeler - CLINIQUE LABORATORIES LLC (044475127)

Registrant - Estee Lauder Companies Inc. (790802086)

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Cosmetics Ltd.		202952982	manufacture(49527-084)

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Cosmetics Ltd.		204132062	label(49527-084) , pack(49527-084)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC KEYSTONE		949264774	label(49527-084) , pack(49527-084)

Establishment
Name	Address	ID/FEI	Business Operations
PALC		078364654	label(49527-084) , pack(49527-084)