FDA.reportPublic FDA data

RETEXTURIZING PRIMER BROAD SPECTRUM SPF 20

Manufacturer
PML NYC, LLC
Effective date
2026-04-17
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:54:12

Label at a glance#

ProductRETEXTURIZING PRIMER BROAD SPECTRUM SPF 20
Active ingredientAVOBENZONE, OCTINOXATE, OCTISALATE
Label structure10 sections

Indications and uses

Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and administration

Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. Use a water-resistant sunscreen if swimming or sweating. Sun Protection Measures: Spending time in the sun increases risk of skin cancer and early 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:...

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 2%

Octinoxate 7.5%

Octisalate 5%

USES

OTC - PURPOSE SECTION

Helps prevent sunburn.
If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

WARNINGS

WARNINGS SECTION

  • 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.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure.
  • Reapply at least every 2 hours.
  • Use a water-resistant sunscreen if swimming or sweating.
  • Sun Protection Measures:
  • Spending time in the sun increases risk of skin cancer and early 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 10:00 a.m. - 2:00 p.m.

  • wear long sleeved shirts, pants, hats and sunglasses.
  • Children under 6 months of age: ask a doctor.

OTHER INFORMATION

OTHER SAFETY INFORMATION

Protect the product in this container from excessive heat and direct sun.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Cyclopentasiloxane, Dimethicone Crosspolymer, Polysilicone-11, C12-15 Alkyl Benzoate, Polyglyceryl-4 Isostearate, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, Laureth-12, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Retinyl Palmitate, Salicylic Acid, Mica, Silica, Phenoxyethanol, Titanium Dioxide

INDICATIONS & USAGE SECTION

Stop use and ask a doctor if rash occurs.

RECENT MAJOR CHANGES SECTION

dosage & admin update

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.

PACKAGE LABELS.PRINCIPLE DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RETEXTURIZING PRIMER SPFRETEXTURIZING PRIMER SPF

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59735-800-09RETEXTURIZING PRIMER BROAD SPECTRUM SPF 2028 g in 1 TUBECREAM285
59735-800-10RETEXTURIZING PRIMER BROAD SPECTRUM SPF 201 in 1 BOXCREAM15

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59735-80059735-800-09, 59735-800-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
AVOBENZONEG63QQF2NOXACTIB
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)UF7620L1W6IACT
OCTINOXATE4Y5P7MUD51ACTIB
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)035JKJ76MTIACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
OCTISALATE4X49Y0596WACTIB
CYCLOMETHICONENMQ347994ZIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYGLYCERYL-4 ISOSTEARATE820DPX33S7IACT
HEXYL LAURATE4CG9F9W01QIACT
LAURETH-12OAH19558U1IACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
SALICYLIC ACIDO414PZ4LPZIACT
MICAV8A1AW0880IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TITANIUM DIOXIDE15FIX9V2JPIACT

Source Document#

Source XML

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
RETEXTURIZING PRIMER BROAD SPECTRUM SPF 20RETEXTURIZING PRIMER BROAD SPECTRUM SPF 20PML NYC, LLC316d905f-232c-d8a2-e063-6394a90adbc92026-04-17WarningsExact identifier
ndc (package): 59735-800-09
ndc (package): 59735-800-10
ndc (product): 59735-800
ndc11 (package): 59735080010
ndc11 (package): 59735080009
spl id: 4fafb975-37a0-0470-e063-6394a90aaf14
spl set id: 316d905f-232c-d8a2-e063-6394a90adbc9

Reported adverse events (FAERS/openFDA)#

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