FDA.reportPublic FDA data

Olay Sun Facial Sunscreen Antioxidants Makeup Primer SPF 35

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2021-01-15
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:56:16

Label at a glance#

ProductOlay Sun Facial Sunscreen Antioxidants Makeup Primer 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

OTC - PURPOSE SECTION

Active IngredientsPurpose
AVOBENZONE 3.0%Sunscreen
HOMOSALATE 9.0%Sunscreen
OCTISALATE 4.5%

Sunscreen

OCTOCRYLENE 8.50%

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

Water, tapioca starch, dimethicone, niacinamide*, tocopheryl acetate**, BHT, caprylyl glycol, dimethiconol, cetearyl glucoside, cetearyl alcohol, camellia sinensis leaf extract***, stearic acid, palmitic acid, disodium EDTA, PEG-100 stearate, polymethylsilsesquioxane, sodium polyacrylate starch, 1,2-hexanediol, phenoxyethanol, iodopropynyl butylcarbamate, fragrance

*Vitamin B3, **Vitamin E, ***Green Tea

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-285-5170

SPL UNCLASSIFIED SECTION

Distr. by PROCTER & GAMBLE,

CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL 40mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OLAY

SUN

Facial Sunscreen

+ Antioxidants

+ Makeup Primer

Broad Spectrum SPF 35 Lotion

40 mL (1.3 FL OZ)

OlayOlay

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69423-33569423-335-40

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
STARCH, TAPIOCA24SC3U704IIACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT
CAPRYLYL GLYCOL00YIU5438UIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
PHENOXYETHANOLHIE492ZZ3TIACT
WATER059QF0KO0RIACT
NIACINAMIDE25X51I8RD4IACT
DIMETHICONE92RU3N3Y1OIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
EDETATE DISODIUM7FLD91C86KIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
STEARIC ACID4ELV7Z65APIACT
PALMITIC ACID2V16EO95H1IACT
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)59Z907ZB69IACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
GREEN TEA LEAFW2ZU1RY8B0IACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
PEG-100 STEARATEYD01N1999RIACT
DIMETHICONOL GUM4MJ9GU3T1PIACT

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
b8f5fcd7-ac69-5671-e053-2995a90a7e637f70ff87-50df-d54c-e053-2991aa0a32f92021-01-15WarningsExact identifier
spl id: b8f5fcd7-ac69-5671-e053-2995a90a7e63
spl set id: 7f70ff87-50df-d54c-e053-2991aa0a32f9

Reported adverse events (FAERS/openFDA)#

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