OTC Medication Information: DOUBLE WEAR CUSHION BB ALL DAY WEAR COMPACT BROAD SPECTRUM SPF 50

DOUBLE WEAR CUSHION BB ALL DAY WEAR COMPACT BROAD SPECTRUM SPF 50- titanium dioxide and zinc oxide paste
ESTEE LAUDER INC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active ingredients Purpose
Titanium Dioxide 7.6 % Sunscreen
Zinc Oxide 5.1% 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 • dimethicone • butyloctyl salicylate • isononyl isononanoate • octyldodecyl neopentanoate • butylene glycol • phenyl trimethicone • lauryl peg-9 polydimethylsiloxyethyl dimethicone • diethylhexyl succinate • methyl trimethicone • silica • dimethicone silylate • tocopheryl acetate • dipentaerythrityl tri-polyhydroxystearate • magnesium sulfate • porphyra yezoensis (algae) extract • laminaria saccharina extract • lens esculenta (lentil) fruit extract • silk powder\serica\poudre de soie • litchi chinensis seed extract • palmaria palmata extract • pyrus malus (apple) fruit extract • citrullus vulgaris (watermelon) fruit extract • acetyl hexapeptide-8 • caffeine • caprylyl methicone • tourmaline • sodium lactate • thermus thermophillus ferment • cetyl peg/ppg-10/1 dimethicone • ascorbyl glucoside • glycerin • hydrolyzed wheat protein/pvp crosspolymer • triethoxycaprylylsilane • caprylyl glycol • sodium pca • polyhydroxystearic acid • sodium hyaluronate • dimethicone crosspolymer-3 • dipropylene glycol • laureth-4 • dimethicone/peg-10/15 crosspolymer • dextrin • sodium benzoate • citric acid • pentylene glycol • phenoxyethanol • chlorphenesin • [+/- mica • titanium dioxide (ci 77891) • iron oxides (ci 77492) • iron oxides (ci 77491) • iron oxides (ci 77499)] <iln42860>

Other information

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

PRINCIPAL DISPLAY PANEL — 12 g Container Carton

ESTĒE LAUDER

Double Wear Cushion

B•B

All Day Wear Liquid Compact Broad Spectrum SPF 50

NET WT. .42 OZ./12g e

PRINCIPAL DISPLAY PANEL -- 12 g Container Carton
(click image for full-size original)
DOUBLE WEAR CUSHION BB ALL DAY WEAR COMPACT BROAD SPECTRUM SPF 50
titanium dioxide and zinc oxide paste
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11559-047
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 7.6 g in 100 g
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 5.1 g in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER
DIMETHICONE
BUTYLOCTYL SALICYLATE
ISONONYL ISONONANOATE
OCTYLDODECYL NEOPENTANOATE
BUTYLENE GLYCOL
PHENYL TRIMETHICONE
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE
DIETHYLHEXYL SUCCINATE
METHYL TRIMETHICONE
SILICON DIOXIDE
.ALPHA.-TOCOPHEROL ACETATE
DIPENTAERYTHRITYL TRI-POLYHYDROXYSTEARATE
MAGNESIUM SULFATE, UNSPECIFIED FORM
SACCHARINA LATISSIMA
LENS CULINARIS FRUIT
LITCHI CHINENSIS SEED
PALMARIA PALMATA
APPLE
WATERMELON
ACETYL HEXAPEPTIDE-8
CAFFEINE
CAPRYLYL TRISILOXANE
SODIUM LACTATE
ASCORBYL GLUCOSIDE
GLYCERIN
TRIETHOXYCAPRYLYLSILANE
CAPRYLYL GLYCOL
SODIUM PYRROLIDONE CARBOXYLATE
HYALURONATE SODIUM
DIPROPYLENE GLYCOL
LAURETH-4
SODIUM BENZOATE
CITRIC ACID MONOHYDRATE
PENTYLENE GLYCOL
PHENOXYETHANOL
CHLORPHENESIN
MICA
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
FERROSOFERRIC OXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:11559-047-01 1 CONTAINER in 1 CARTON contains a CONTAINER
1 12 g in 1 CONTAINER This package is contained within the CARTON (11559-047-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 07/01/2016
Labeler — ESTEE LAUDER INC (005914387)
Registrant — Estee Lauder Companies Inc. (790802086)
Establishment
Name Address ID/FEI Operations
Whitman Laboratories Ltd. 216866277 MANUFACTURE (11559-047), REPACK (11559-047), RELABEL (11559-047)
Establishment
Name Address ID/FEI Operations
ESTEE LAUDER COMPANY, THE 828534516 REPACK (11559-047), RELABEL (11559-047)
Establishment
Name Address ID/FEI Operations
Estee Lauder Cosmetics Ltd. 202952982 MANUFACTURE (11559-047), REPACK (11559-047), RELABEL (11559-047)
Establishment
Name Address ID/FEI Operations
Estee Lauder Cosmetics Ltd. 204132062 RELABEL (11559-047), REPACK (11559-047)
Establishment
Name Address ID/FEI Operations
Estee Lauder N.V. 370151326 MANUFACTURE (11559-047), REPACK (11559-047), RELABEL (11559-047)
Establishment
Name Address ID/FEI Operations
NORTHTEC INC 943871157 REPACK (11559-047), RELABEL (11559-047)
Establishment
Name Address ID/FEI Operations
NORTHTEC PALC 102631997 REPACK (11559-047), RELABEL (11559-047)
Establishment
Name Address ID/FEI Operations
Len-Ron Manufacturing Division of Aramis Inc. 809771152 MANUFACTURE (11559-047), REPACK (11559-047), RELABEL (11559-047)
Establishment
Name Address ID/FEI Operations
PADC 1 949264774 REPACK (11559-047), RELABEL (11559-047)
Establishment
Name Address ID/FEI Operations
Nippon Shikizai,inc. 692076308 MANUFACTURE (11559-047)

Revised: 07/2021 ESTEE LAUDER INC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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