FLAWLESS SKIN MAKEUP BROAD SPECTRUM SPF 15

Manufacturer
PRESCRIPTIVES INC. | ESTEE LAUDER COMPANY, THE | ESTEE LAUDER COSMETICS, LTD | ESTEE LAUDER COSMETICS, LTD. | ESTEE LAUDER N.V. | LEN-RON MANUFACTURING DIVISION OF ARAMIS INC | NORTHTEC INC | PADC 1 | WHITMAN LABORATORIES, LTD.
Effective date
2018-12-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:44:03

Label at a glance#

ProductFLAWLESS SKIN MAKEUP BROAD SPECTRUM SPF 15
Active ingredientOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE
Label structure9 sections

Dosage and administration

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...

Storage and handling

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

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 4.10%
Titanium Dioxide 1.40%
Zinc Oxide 1.50%

OTC - PURPOSE SECTION

Sunscreen

Use

INDICATIONS & USAGE SECTION

helps prevent sunburn

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

water\aqua\eau ■ cyclopentasiloxane ■ phenyl trimethicone ■ dimethicone ■ dimethicone silylate ■ butylene glycol ■ peg/ppg-18/18 dimethicone ■ silica ■ micrococcus lysate ■ polygonum cuspidatum root extract ■ quaternium-90 bentonite ■ ethylhexylglycerin ■ rosmarinus officinalis (rosemary) extract ■ octyldodecyl neopentanoate ■ tocopheryl acetate ■ triethoxycaprylylsilane ■ polysilicone-11 ■ magnesium sulfate ■ disteardimonium hectorite ■ lecithin ■ polyglyceryl-6 polyricinoleate ■ trifluoromethyl c1-4 alkyl dimethicone ■ laureth-7 ■ isopropyl titanium triisostearate ■ propylene carbonate ■ chamomilla recutita (matricaria) ■ alumina ■ chloroxylenol ■ phenoxyethanol ■ [+/- titanium dioxide (ci 77891) ■ mica ■ iron oxides (ci 77491, ci 77492, ci 77499)] <iln33886>

Other information

STORAGE AND HANDLING SECTION

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

SPL UNCLASSIFIED SECTION

PRESCRIPTIVES CO., DIST.,
NEW YORK, N.Y. 10022

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRESCRIPTIVES

Flawless Skin

Makeup

Broad Spectrum SPF 15

1 FL. OZ./OZ. LIQ./30 ml e

Principal Display Panel - 30 ml Bottle Carton
Principal Display Panel - 30 ml Bottle Carton

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD511
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JP1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z1
OCTINOXATEACTIVE MOIETY4Y5P7MUD511
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JP1
ZINC OXIDEACTIVE MOIETYSOI2LOH54Z1
.alpha.-tocopherol acetateINACTIVE INGREDIENT9E8X80D2L01
aluminum oxideINACTIVE INGREDIENTLMI26O69331
butylene glycolINACTIVE INGREDIENT3XUS85K0RA1
chloroxylenolINACTIVE INGREDIENT0F32U78V2Q1
cyclomethicone 5INACTIVE INGREDIENT0THT5PCI0R1
dimethiconeINACTIVE INGREDIENT92RU3N3Y1O1
ethylhexylglycerinINACTIVE INGREDIENT147D247K3P1
ferric oxide redINACTIVE INGREDIENT1K09F3G6751
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRT1
ferrosoferric oxideINACTIVE INGREDIENTXM0M87F3571
isopropyl titanium triisostearateINACTIVE INGREDIENT949E3KBJ1I1
laureth-7INACTIVE INGREDIENTZ95S6G82011
magnesium sulfateINACTIVE INGREDIENTDE08037SAB1
matricaria recutitaINACTIVE INGREDIENTG0R4UBI2ZZ1
micaINACTIVE INGREDIENTV8A1AW08801
octyldodecyl neopentanoateINACTIVE INGREDIENTX8725R883T1
peg/ppg-18/18 dimethiconeINACTIVE INGREDIENT9H0AO7T7941
phenoxyethanolINACTIVE INGREDIENTHIE492ZZ3T1
phenyl trimethiconeINACTIVE INGREDIENTDR0K5NOJ4R1
polygonum cuspidatum rootINACTIVE INGREDIENT7TRV45YZF71
propylene carbonateINACTIVE INGREDIENT8D08K3S51E1
rosemaryINACTIVE INGREDIENTIJ67X351P91
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU41
triethoxycaprylylsilaneINACTIVE INGREDIENTLDC331P08E1
waterINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59158-76059158-760-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 127 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4TABLET / ORAL750 mgExact identifier — unii candidate
49 equally ranked IID candidates
ferric oxide yellowFERRIC OXIDE YELLOWEX438O2MRTCAPSULE, COATED / ORAL0.01 mgExact identifier — unii candidate
20 equally ranked IID candidates
aluminum oxideALUMINUM OXIDELMI26O6933SPONGE / TOPICALNAExact identifier — unii candidate
2 equally ranked IID candidates
ferric oxide redFERRIC OXIDE RED1K09F3G675TABLET, EXTENDED RELEASE / ORAL7 mgExact identifier — unii candidate
21 equally ranked IID candidates
ferric oxide yellowFERRIC OXIDE YELLOWEX438O2MRTTABLET / SUBLINGUAL1 mgExact identifier — unii candidate
20 equally ranked IID candidates
ferric oxide redFERRIC OXIDE RED1K09F3G675CAPSULE, COATED PELLETS / ORAL2 mgExact identifier — unii candidate
21 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4TABLET, FILM COATED, EXTENDED RELEASE / ORAL336 mgExact identifier — unii candidate
49 equally ranked IID candidates
ferrosoferric oxideFERROSOFERRIC OXIDEXM0M87F357TABLET, COATED / ORALNAExact identifier — unii candidate
10 equally ranked IID candidates
ferric oxide yellowFERRIC OXIDE YELLOWEX438O2MRTTABLET, ORALLY DISINTEGRATING / ORAL2 mgExact identifier — unii candidate
20 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4TABLET, FOR SUSPENSION / ORAL220 mgExact identifier — unii candidate
49 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4GRANULE, FOR SUSPENSION / ORAL200 mgExact identifier — unii candidate
49 equally ranked IID candidates
ferric oxide redFERRIC OXIDE RED1K09F3G675SUSPENSION, EXTENDED RELEASE / ORAL2.7 mgExact identifier — unii candidate
21 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4CREAM / VAGINAL51 mgExact identifier — unii candidate
49 equally ranked IID candidates
ferric oxide redFERRIC OXIDE RED1K09F3G675CREAM / TOPICALNAExact identifier — unii candidate
21 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
49 equally ranked IID candidates
phenoxyethanolPHENOXYETHANOLHIE492ZZ3TCREAM, AUGMENTED / TOPICAL10 mgExact identifier — unii candidate
6 equally ranked IID candidates
ferric oxide redFERRIC OXIDE RED1K09F3G675TABLET, CHEWABLE / ORAL2 mgExact identifier — unii candidate
21 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4CAPSULE / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
49 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4TABLET, EXTENDED RELEASE / ORAL450 mgExact identifier — unii candidate
49 equally ranked IID candidates
ferrosoferric oxideFERROSOFERRIC OXIDEXM0M87F357CAPSULE, DELAYED RELEASE / ORAL6 mgExact identifier — unii candidate
10 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4GRANULE, FOR SOLUTION / ORAL1.8 mg/120mlExact identifier — unii candidate
49 equally ranked IID candidates
ferric oxide redFERRIC OXIDE RED1K09F3G675CAPSULE, EXTENDED RELEASE / ORAL5 mgExact identifier — unii candidate
21 equally ranked IID candidates
ferric oxide redFERRIC OXIDE RED1K09F3G675TABLET, COATED / ORAL1 mgExact identifier — unii candidate
21 equally ranked IID candidates
ferrosoferric oxideFERROSOFERRIC OXIDEXM0M87F357POWDER, FOR SUSPENSION / ORALNAExact identifier — unii candidate
10 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4FILM, SOLUBLE / ORAL2 mgExact identifier — unii candidate
49 equally ranked IID candidates
ferrosoferric oxideFERROSOFERRIC OXIDEXM0M87F357CAPSULE, COATED / ORAL0.11 mgExact identifier — unii candidate
10 equally ranked IID candidates
ferrosoferric oxideFERROSOFERRIC OXIDEXM0M87F357TABLET / ORAL2 mgExact identifier — unii candidate
10 equally ranked IID candidates
ferrosoferric oxideFERROSOFERRIC OXIDEXM0M87F357TABLET, FILM COATED / ORAL0.2 mgExact identifier — unii candidate
10 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4CAPSULE, COATED PELLETS / ORAL69 mgExact identifier — unii candidate
49 equally ranked IID candidates
magnesium sulfateMAGNESIUM SULFATEDE08037SABTABLET, COATED / ORALNAExact identifier — unii candidate
6 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4PELLET / ORAL34 mgExact identifier — unii candidate
49 equally ranked IID candidates
peg/ppg-18/18 dimethiconePEG/PPG-18/18 DIMETHICONE9H0AO7T794GEL / TOPICAL1 %w/wExact identifier — unii candidate
2 equally ranked IID candidates
ferric oxide redFERRIC OXIDE RED1K09F3G675CAPSULE, COATED / ORAL0.12 mgExact identifier — unii candidate
21 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4SUSPENSION / ORAL400 mgExact identifier — unii candidate
49 equally ranked IID candidates
aluminum oxideALUMINUM OXIDELMI26O6933TABLET / ORALNAExact identifier — unii candidate
2 equally ranked IID candidates
magnesium sulfateMAGNESIUM SULFATEDE08037SABSOAP / TOPICAL0.2 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4POWDER, FOR SOLUTION / ORAL280 mgExact identifier — unii candidate
49 equally ranked IID candidates
ferrosoferric oxideFERROSOFERRIC OXIDEXM0M87F357TABLET, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
10 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4TABLET / BUCCAL3 mgExact identifier — unii candidate
49 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4GEL / NASAL20 mgExact identifier — unii candidate
49 equally ranked IID candidates
ferric oxide yellowFERRIC OXIDE YELLOWEX438O2MRTCAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
20 equally ranked IID candidates
ferric oxide yellowFERRIC OXIDE YELLOWEX438O2MRTPOWDER, FOR SUSPENSION / ORAL3 mgExact identifier — unii candidate
20 equally ranked IID candidates
ferric oxide redFERRIC OXIDE RED1K09F3G675POWDER, FOR SUSPENSION / ORAL1 mgExact identifier — unii candidate
21 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4POWDER / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
49 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4SUPPOSITORY / RECTAL14 mgExact identifier — unii candidate
49 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4CAPSULE, DELAYED RELEASE / ORAL40 mgExact identifier — unii candidate
49 equally ranked IID candidates
phenoxyethanolPHENOXYETHANOLHIE492ZZ3TGEL / TOPICAL14 mgExact identifier — unii candidate
6 equally ranked IID candidates
ferric oxide redFERRIC OXIDE RED1K09F3G675TABLET / BUCCAL0.4 mgExact identifier — unii candidate
21 equally ranked IID candidates
propylene carbonatePROPYLENE CARBONATE8D08K3S51EOINTMENT / TOPICAL3000 mgExact identifier — unii candidate
ferric oxide redFERRIC OXIDE RED1K09F3G675CAPSULE / ORAL5 mgExact identifier — unii candidate
21 equally ranked IID candidates
phenoxyethanolPHENOXYETHANOLHIE492ZZ3TAEROSOL, FOAM / TOPICAL72 mgExact identifier — unii candidate
6 equally ranked IID candidates
magnesium sulfateMAGNESIUM SULFATEDE08037SABTABLET / ORAL2.9 mgExact identifier — unii candidate
6 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL69 mgExact identifier — unii candidate
49 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4CAPSULE / ORAL300 mgExact identifier — unii candidate
49 equally ranked IID candidates
ferric oxide yellowFERRIC OXIDE YELLOWEX438O2MRTTABLET, CHEWABLE / ORAL14 mgExact identifier — unii candidate
20 equally ranked IID candidates
magnesium sulfateMAGNESIUM SULFATEDE08037SABCAPSULE / ORALNAExact identifier — unii candidate
6 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4TABLET, CHEWABLE / ORAL254 mgExact identifier — unii candidate
49 equally ranked IID candidates
cyclomethicone 5CYCLOMETHICONE 50THT5PCI0RCREAM, AUGMENTED / TOPICAL260 mgExact identifier — unii candidate
3 equally ranked IID candidates
ferric oxide yellowFERRIC OXIDE YELLOWEX438O2MRTGRANULE, FOR SUSPENSION / ORAL11 mgExact identifier — unii candidate
20 equally ranked IID candidates
phenoxyethanolPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii candidate
6 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
6327e6cb-6c9e-4338-8111-6ad8ded682a0696cb885-2bfb-426b-8284-1ec888b1090a2018-12-06WarningsExact identifier
spl set id: 696cb885-2bfb-426b-8284-1ec888b1090a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.