SUPERDEFENSE BROAD SPECTRUM SPF 25 FATIGUE PLUS 1ST SIGNS OF AGE MULTI-CORRECTING- avobenzone and octisalate cream

SUPERDEFENSE BROAD SPECTRUM SPF 25 FATIGUE plus 1ST SIGNS OF AGE MULTI-CORRECTING by

Drug Labeling and Warnings

SUPERDEFENSE BROAD SPECTRUM SPF 25 FATIGUE plus 1ST SIGNS OF AGE MULTI-CORRECTING by is a Otc medication manufactured, distributed, or labeled by CLINIQUE LABORATORIES LLC, Estee Lauder Companies Inc., PALC, NORTHTEC LLC, Estee Lauder Cosmetics Ltd., Whitman Laboratories Ltd., Estee Lauder N.V., The Estee Lauder Inc, PADC 1. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Avobenzone 3.0%
Octisalate 5.0%

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\aqua\eau glycerin neopentyl glycol diheptanoate polyester-8 dimethicone sorbitan stearate butyloctyl salicylate polysorbate 60 butylene glycol sodium acrylates copolymer silica cetyl alcohol niacinamide pentylene glycol brassica oleracea gemmifera (brussels sprouts) extract vaccinium angustifolium (blueberry) fruit extract brassica oleracea italica (broccoli) extract daucus carota sativa (carrot) root extract brassica oleracea acephala (kale) leaf extract spinacia oleracea (spinach) leaf extract resveratrol plankton extract oryza sativa (rice) bran extract vaccinium macrocarpon (cranberry) fruit extract cucumis sativus (cucumber) fruit extract adenosine phosphate salicylic acid laminaria saccharina extract creatine arabidopsis thaliana extract lactobacillus ferment ergothioneine micrococcus lysate biosaccharide gum-4 algae extract acetyl carnitine hcl caffeine hordeum vulgare (barley) extract\extrait d'orge albizia julibrissin bark extract sigesbeckia orientalis (st. paul's wort) extract sodium rna sodium hyaluronate 7-dehydrocholesterol styrene/acrylates copolymer isohexadecane tocopheryl acetate peg-100 stearate trehalose ethylhexylglycerin lecithin propylene glycol dicaprate polyethylene helianthus annuus (sunflower) seedcake yeast extract\faex\extrait de levure capryloyl glycine peg-8 laurate polysorbate 80 acrylamide/sodium acryloyldimethyltaurate copolymer phytic acid sea whip extract tetrahexyldecyl ascorbate propylene glycol caprylate disodium edta bht chlorphenesin phenoxyethanol titanium dioxide (ci 77891) mica [iln44660]

Other information

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

PRINCIPAL DISPLAY PANEL - 50 ml Jar Carton

de-aging

CLINIQUE

superdefense
broad spectrum SPF 25

fatigue + 1st signs of age
multi-correcting cream

COMBINATION OILY TO OILY

NET WT. 1.7 OZ./50 ml e

INGREDIENTS AND APPEARANCE

SUPERDEFENSE BROAD SPECTRUM SPF 25 FATIGUE PLUS 1ST SIGNS OF AGE MULTI-CORRECTING 
avobenzone and octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49527-075
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.0306 g  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.051 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
glycerin (UNII: PDC6A3C0OX)
neopentyl glycol diheptanoate (UNII: 5LKW3C543X)
polyester-8 (1400 mw, cyanodiphenylpropenoyl capped) (UNII: T9296U138P)
dimethicone (UNII: 92RU3N3Y1O)
sorbitan monostearate (UNII: NVZ4I0H58X)
butyloctyl salicylate (UNII: 2EH13UN8D3)
polysorbate 60 (UNII: CAL22UVI4M)
butylene glycol (UNII: 3XUS85K0RA)
silicon dioxide (UNII: ETJ7Z6XBU4)
cetyl alcohol (UNII: 936JST6JCN)
niacinamide (UNII: 25X51I8RD4)
pentylene glycol (UNII: 50C1307PZG)
brussels sprout (UNII: KHX46H31F8)
lowbush blueberry (UNII: G90PX41VP0)
broccoli (UNII: UOI4FT57BZ)
carrot (UNII: L56Z1JK48B)
kale (UNII: 0Y3L4J38H1)
spinach (UNII: 6WO75C6WVB)
resveratrol (UNII: Q369O8926L)
rice bran (UNII: R60QEP13IC)
cranberry (UNII: 0MVO31Q3QS)
cucumber (UNII: YY7C30VXJT)
adenosine phosphate (UNII: 415SHH325A)
salicylic acid (UNII: O414PZ4LPZ)
saccharina latissima (UNII: 68CMP2MB55)
creatine (UNII: MU72812GK0)
arabidopsis thaliana (UNII: AI3L60HQ81)
lactobacillus reuteri (UNII: 9913I24QEE)
ergothioneine (UNII: BDZ3DQM98W)
biosaccharide gum-4 (UNII: 9XRL057X90)
acetylcarnitine hydrochloride (UNII: NDW10MX58T)
caffeine (UNII: 3G6A5W338E)
barley (UNII: 5PWM7YLI7R)
albizia julibrissin bark (UNII: 0J9G6W44DV)
hyaluronate sodium (UNII: YSE9PPT4TH)
7-dehydrocholesterol (UNII: BK1IU07GKF)
isohexadecane (UNII: 918X1OUF1E)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
peg-100 stearate (UNII: YD01N1999R)
trehalose (UNII: B8WCK70T7I)
ethylhexylglycerin (UNII: 147D247K3P)
propylene glycol dicaprate (UNII: U783H9JHWY)
high density polyethylene (UNII: UG00KM4WR7)
helianthus annuus seedcake (UNII: 482WYF7XLC)
yeast, unspecified (UNII: 3NY3SM6B8U)
capryloyl glycine (UNII: 8TY5YO42NJ)
peg-8 laurate (UNII: 762O8IWA10)
polysorbate 80 (UNII: 6OZP39ZG8H)
fytic acid (UNII: 7IGF0S7R8I)
pseudopterogorgia elisabethae (UNII: UDY3H1OUX5)
tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)
propylene glycol caprylate (UNII: RT9P9S09QI)
edetate disodium anhydrous (UNII: 8NLQ36F6MM)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
chlorphenesin (UNII: I670DAL4SZ)
phenoxyethanol (UNII: HIE492ZZ3T)
titanium dioxide (UNII: 15FIX9V2JP)
mica (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49527-075-01	1 in 1 CARTON	11/21/2019
1		50 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 NOT FINAL	part352	11/21/2019

Labeler - CLINIQUE LABORATORIES LLC (044475127)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(49527-075) , REPACK(49527-075)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(49527-075)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(49527-075)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(49527-075)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(49527-075)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(49527-075) , REPACK(49527-075)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(49527-075) , REPACK(49527-075)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(49527-075)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(49527-075)