SUPERDEFENSE BROAD SPECTRUM SPF 25 FATIGUE PLUS 1ST SIGNS OF AGE MULTI-CORRECTING VERY DRY TO DRY COMBINATION- avobenzone, homosalate, and octisalate cream

SUPERDEFENSE BROAD SPECTRUM SPF 25 FATIGUE PLUS 1ST SIGNS OF AGE MULTI-CORRECTING VERY DRY TO DRY COMBINATION by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Avobenzone 3.0%
Homosalate 5.0%
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 butyloctyl salicylate dimethicone polyester-8 cetearyl alcohol glyceryl stearate peg-100 stearate shea butter ethyl esters butylene glycol petrolatum styrene/acrylates copolymer glycerin niacinamide trehalose vp/eicosene copolymer daucus carota sative (carrot) root extract brassica oleracea gemmifera (brussels sprouts) extract vaccinium macrocarpon (cranberry) fruit extract resveratrol brassica oleracea italica (broccoli) extract acetyl carnitine hcl vaccinium angustifolium (blueberry) fruit extract salicylic acid brassica oleracea acephala (kale) leaf extract creatine spinacia oleracea (spinach) leaf extract cucumis sativus (cucumber) fruit extract lactobacillus ferment adenosine phosphate hordeum vulgare (barley) extract\extrait d'orge sigesbeckia orientalis (st. paul's wort) extract albizia julibrissin bark extract arabidopsis thaliana extract plankton extract isohexadecane oryza sativa (rice) bran extract potassium cetyl phosphate tocopheryl acetate caffeine ethylhexylglycerin algae extract micrococcus lysate ergothioneine sodium hyaluronate 7-dehydrocholesterol caprylyl glycol biosaccharide gum-4 hydrogenated palm glycerides acrylates/c10-30 alkyl acrylate crosspolymer propylene glycol dicaprate peg-8 laurate helianthus annuus (sunflower) seedcake polyethylene yeast extract\faex\extrait de levure tromethamine dimethiconol sodium rna polysorbate 80 lecithin sea whip extract xanthan gum acrylamide/sodium acryloyldimethyltaurate copolymer tetrahexyldecyl ascorbate propylene glycol caprylate phytic acid disodium edta bht phenoxyethanol mica titanium dioxide (ci 77891) [iln44658]

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

VERY DRY TO DRY COMBINATION

NET WT. 1.7 OZ./50 ml e

INGREDIENTS AND APPEARANCE

SUPERDEFENSE BROAD SPECTRUM SPF 25 FATIGUE PLUS 1ST SIGNS OF AGE MULTI-CORRECTING VERY DRY TO DRY COMBINATION 
avobenzone, homosalate, and octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49527-077
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	50 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
butyloctyl salicylate (UNII: 2EH13UN8D3)
dimethicone (UNII: 92RU3N3Y1O)
polyester-8 (1400 mw, cyanodiphenylpropenoyl capped) (UNII: T9296U138P)
cetostearyl alcohol (UNII: 2DMT128M1S)
glyceryl monostearate (UNII: 230OU9XXE4)
peg-100 stearate (UNII: YD01N1999R)
butylene glycol (UNII: 3XUS85K0RA)
petrolatum (UNII: 4T6H12BN9U)
styrene/acrylamide copolymer (500000 mw) (UNII: 5Z4DPO246A)
glycerin (UNII: PDC6A3C0OX)
niacinamide (UNII: 25X51I8RD4)
trehalose (UNII: B8WCK70T7I)
carrot (UNII: L56Z1JK48B)
brussels sprout (UNII: KHX46H31F8)
cranberry (UNII: 0MVO31Q3QS)
resveratrol (UNII: Q369O8926L)
broccoli (UNII: UOI4FT57BZ)
Acetylcarnitine Hydrochloride (UNII: NDW10MX58T)
lowbush blueberry (UNII: G90PX41VP0)
salicylic acid (UNII: O414PZ4LPZ)
kale (UNII: 0Y3L4J38H1)
creatine (UNII: MU72812GK0)
spinach (UNII: 6WO75C6WVB)
cucumber (UNII: YY7C30VXJT)
adenosine phosphate (UNII: 415SHH325A)
barley (UNII: 5PWM7YLI7R)
albizia julibrissin bark (UNII: 0J9G6W44DV)
arabidopsis thaliana (UNII: AI3L60HQ81)
isohexadecane (UNII: 918X1OUF1E)
rice bran (UNII: R60QEP13IC)
potassium cetyl phosphate (UNII: 03KCY6P7UT)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
caffeine (UNII: 3G6A5W338E)
ethylhexylglycerin (UNII: 147D247K3P)
ergothioneine (UNII: BDZ3DQM98W)
hyaluronate sodium (UNII: YSE9PPT4TH)
7-dehydrocholesterol (UNII: BK1IU07GKF)
caprylyl glycol (UNII: 00YIU5438U)
biosaccharide gum-4 (UNII: 9XRL057X90)
hydrogenated palm glycerides (UNII: YCZ8EM144Q)
carbomer interpolymer type a (allyl sucrose crosslinked) (UNII: 59TL3WG5CO)
propylene glycol dicaprate (UNII: U783H9JHWY)
peg-8 laurate (UNII: 762O8IWA10)
helianthus annuus seedcake (UNII: 482WYF7XLC)
high density polyethylene (UNII: UG00KM4WR7)
tromethamine (UNII: 023C2WHX2V)
polysorbate 80 (UNII: 6OZP39ZG8H)
pseudopterogorgia elisabethae (UNII: UDY3H1OUX5)
xanthan gum (UNII: TTV12P4NEE)
tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)
propylene glycol caprylate (UNII: RT9P9S09QI)
fytic acid (UNII: 7IGF0S7R8I)
edetate disodium anhydrous (UNII: 8NLQ36F6MM)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
phenoxyethanol (UNII: HIE492ZZ3T)
mica (UNII: V8A1AW0880)
titanium dioxide (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49527-077-01	1 in 1 CARTON	01/28/2020
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	01/28/2020

Labeler - CLINIQUE LABORATORIES LLC (044475127)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(49527-077) , REPACK(49527-077)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(49527-077)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(49527-077)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(49527-077)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(49527-077)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(49527-077) , REPACK(49527-077)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(49527-077) , REPACK(49527-077)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(49527-077)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(49527-077)