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Olay Super Cream with Sunscreen Broad Spectrum SPF 30

Olay Super Cream with Sunscreen Broad Spectrum SPF 30

Approved
Approval ID

372819f1-0813-2cd5-e063-6294a90ac5bf

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jun 9, 2025

Manufacturers
FDA

The Procter & Gamble Manufacturing Company

DUNS: 004238200

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Avobenzone, Homosalate, Octisalate, and Octocrylene

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code84126-153
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
Avobenzone, Homosalate, Octisalate, and Octocrylene
Product Specifications
Route of AdministrationTOPICAL
Effective DateJune 9, 2025
FDA Product Classification

INGREDIENTS (28)

PALMITIC ACIDInactive
Code: 2V16EO95H1
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PEG-100 STEARATEInactive
Code: YD01N1999R
Classification: IACT
CETEARYL GLUCOSIDEInactive
Code: 09FUA47KNA
Classification: IACT
CETEARYL ALCOHOLInactive
Code: 2DMT128M1S
Classification: IACT
BEHENYL ALCOHOLInactive
Code: 9G1OE216XY
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
CAPRYLYL GLYCOLInactive
Code: 00YIU5438U
Classification: IACT
NIACINAMIDEInactive
Code: 25X51I8RD4
Classification: IACT
ZEA MAYS (CORN) STARCHInactive
Code: O8232NY3SJ
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT
PANTHENOLInactive
Code: WV9CM0O67Z
Classification: IACT
PALMITOYL PENTAPEPTIDE-4Inactive
Code: KK181SM5JG
Classification: IACT
OCTISALATEActive
Quantity: 4.5 g in 100 g
Code: 4X49Y0596W
Classification: ACTIB
1,2-HEXANEDIOLInactive
Code: TR046Y3K1G
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
AVOBENZONEActive
Quantity: 3 g in 100 g
Code: G63QQF2NOX
Classification: ACTIB
HOMOSALATEActive
Quantity: 9 g in 100 g
Code: V06SV4M95S
Classification: ACTIB
DIMETHICONOL (50000 CST)Inactive
Code: R2285D73YT
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SODIUM HYALURONATEInactive
Code: YSE9PPT4TH
Classification: IACT
SODIUM POLYACRYLATE STARCH (12 MICROMETER PARTICLE)Inactive
Code: 3F3VT8K8DM
Classification: IACT
3-O-ETHYL ASCORBIC ACIDInactive
Code: 6MW60CB71P
Classification: IACT
ALPHA-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0
Classification: IACT
OCTOCRYLENEActive
Quantity: 6 g in 100 g
Code: 5A68WGF6WM
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 1/30/2025

PRINCIPAL DISPLAY PANEL - Carton

OLAY

SUPER

CREAM

WITH SUNSCREEN

BROAD SPECTRUM SPF 30

50 g (1.7 OZ)

Olay

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/24/2015

Uses

  • helps prevent sunburn
  • if used as directed with other sun protection measures (seeDirections), decreases the risk of skin cancer and early skin aging caused by the sun

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 8/24/2015

Distr. by PROCTER & GAMBLE,
CINCINNATI, OH 45202

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/1/2024

AVOBENZONE 3.0%

HOMOSALATE 9.0%

OCTISALATE 4.5%

OCTOCRYLENE 6.0%

Sunscreen

WARNINGS SECTION

LOINC: 34071-1Updated: 8/24/2015

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.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/24/2015

Directions

  • 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

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 8/24/2015

Other information

  • protect this product from excessive heat and direct sun

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 1/30/2025

Inactive ingredients

Water, zea mays (corn) starch, glycerin, niacinamide, dimethicone, 3-O-ethyl ascorbic acid, sodium hyaluronate, tocopheryl acetate, palmitoyl pentapeptide-4, panthenol, caprylyl glycol, dimethiconol, cetearyl alcohol, cetearyl glucoside, palmitic acid, stearic acid, behenyl alcohol, stearyl alcohol, cetyl alcohol, disodium EDTA, PEG-100 stearate, 1,2-hexanediol, sodium polyacrylate starch, phenoxyethanol, fragrance

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 8/24/2015

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Olay Super Cream with Sunscreen Broad Spectrum SPF 30 - FDA Drug Approval Details