FDA.reportPublic FDA data

Avobenzone, Homosalate, Octisalate, and Octocrylene

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2026-03-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:48:48

Label at a glance#

ProductOlay Complete plus Principle Invisible Facial Primer plus Sunscreen Broad Spectrum SPF 35
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
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 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 sun, especially from 1...

Storage and handling

protect this product from excessive heat and direct sun

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.0%

Homosalate 10.0%

Octisalate 5.0%

Octocrylene 10.0%

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE 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

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

  • apply liberally 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use 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 sun, especially from 10 a.m. – 2 p.m.
    • wear long-sleeved shirts, pants, hats, and sunglasses
  • children under 6 months: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • protect this product from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

Isododecane, dimethicone crosspolymer, dimethicone/bis-isobutyl PPG-20 crosspolymer, aloe barbadensis leaf extract*, tetrahexyldecyl ascorbate**, tocopheryl acetate***, neopentyl glycol diheptanoate, brassica campestris (rapeseed) seed oil, caprylyl glycol, silica silylate, polyester-7

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-285-5170

SPL UNCLASSIFIED SECTION

Dist. by PROCTER & GAMBLE,
CINCINNATI, OH 45202

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OLAY

COMPLETE +

INVISIBLE FACIAL

PRIMER + SUNSCREEN

Broad Spectrum SPF 35

VITAMIN C & E

60 mL (2.0 FL OZ)

OLAYOLAY

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeData Matrix21353131OLAY.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84126-330-60Olay Complete plus Principle Invisible Facial Primer plus Sunscreen Broad Spectrum SPF 3560 mL in 1 TUBELOTION601
84126-330-60Olay Complete plus Principle Invisible Facial Primer plus Sunscreen Broad Spectrum SPF 351 in 1 CARTONLOTION11

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84126-33084126-330-60

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
ISODODECANEA8289P68Y2IACT
POLYESTER-70841698D2FIACT
ALOE BARBADENSIS LEAFZY81Z83H0XIACT
DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMERO4I3UFO6ZFIACT
SILICA DIMETHYL SILYLATEEU2PSP0G0WIACT
CAPRYLYL GLYCOL00YIU5438UIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
BRASSICA CAMPESTRIS (RAPESEED) SEED OILN4G8379626IACT
NEOPENTYL GLYCOL DIHEPTANOATE5LKW3C543XIACT
DIMETHICONE CROSSPOLYMERUF7620L1W6IACT

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
Olay Complete plus Principle Invisible Facial Primer plus Sunscreen Broad Spectrum SPF 35AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company4c231aa1-75eb-c171-e063-6294a90a8b8b2026-03-03WarningsExact identifier
ndc (package): 84126-330-60
ndc (product): 84126-330
ndc11 (package): 84126033060
spl id: 4c231a7f-aa68-db0c-e063-6294a90aceee
spl set id: 4c231aa1-75eb-c171-e063-6294a90a8b8b

Reported adverse events (FAERS/openFDA)#

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