FDA.reportPublic FDA data

Drug Facts

Manufacturer
L'Oreal USA Products Inc | L'OREAL USA PRODUCTS, INC.
Effective date
2023-12-29
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:05:57

Label at a glance#

ProductLoreal Paris Age Perfect Rosy Tone SPF 30 Renew and revive healthy tone Visibly younger-looking skin
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure12 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

For sunscreen use: apply liberally 15 minutes before sun exposure reapply at least every 2 hours use a water resistant suncreen 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...

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

Avobenzone 3%

Homosalate 2.7%

Octisalate 5%

Octocrylene 7%

Purpose

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

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

OTC - STOP USE SECTION

rash occurs

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If 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 2 hours
  • use a water resistant suncreen 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 shrits, pants, hat and sunglasses
  • children under 6 months of age: Ask a doctor

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, glycerin, cetearyl alcohol, isohexadecane, glyceryl stearate, cyclohexasiloxane, isononyl isononanoate, butyrospermum parkii (shea) butter, PEG-100 stearate, butylene glycol, ceteareth-20, phenoxyethanol, synthetic fluorphlogopite, ammonium polyacryloyldimethyl taurate, caprylyl glycol, tocopherol, chlorphenesin, xanthan gum, disodium EDTA, titanium dioxide, mica, fragrance, p-anisic acid, paeonia albiflora root extract, bismuth oxychloride, iron oxides, adenosine, iris florentina root extract, sodium hydroxide, tin oxide, hexyl cinnamal, benzyl alcohol, hydroxycitrinellal, benzyl salicylate, linalool, citronellol, limonene, geraniol, alpha-isomethyl ionone, citric acid

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of a labelimage of a label

image of a label
image of a label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d676a241-be05-4740-b3ee-1a5f2ed422d2Product name420180615
dd8bd48f-20d6-43c7-b471-3ae872868afaProduct name320180125
d41954ff-bc63-4b2c-aba0-9146707659d7Product name220151117
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-394-01Loreal Paris Age Perfect Rosy Tone SPF 30 Renew and revive healthy tone Visibly younger-looking skin1 in 1 CARTONLOTION13
49967-394-01Loreal Paris Age Perfect Rosy Tone SPF 30 Renew and revive healthy tone Visibly younger-looking skin48 mL in 1 JARLOTION483
49967-394-02Loreal Paris Age Perfect Rosy Tone SPF 30 Renew and revive healthy tone Visibly younger-looking skin75 mL in 1 JARLOTION753
49967-394-02Loreal Paris Age Perfect Rosy Tone SPF 30 Renew and revive healthy tone Visibly younger-looking skin1 in 1 CARTONLOTION13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-394LOREAL PARIS AGE PERFECT ROSY TONE SPF 30 RENEW AND REVIVE HEALTHY TONE VISIBLY YOUNGER-LOOKING SKIN (AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE) LOTION [L'OREAL USA PRODUCTS INC]3Current NDC, Legacy NDC, 4 package rows20231230_1c83726b-f8ff-48d5-bf30-bc75e3fb149d.zip

Products#

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

DailyMed product names page 1 of 2 · 44 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49967-39449967-394-01, 49967-394-02

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 42 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CYCLOMETHICONE 6XHK3U310BAIACT
ISONONYL ISONONANOATES4V5BS6GCXIACT
ISOHEXADECANE918X1OUF1EIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
SHEA BUTTERK49155WL9YIACT
PEG-100 STEARATEYD01N1999RIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
PHENOXYETHANOLHIE492ZZ3TIACT
AMMONIUM POLYACRYLOYLDIMETHYL TAURATE (55000 MPA.S)F01RIY4371IACT
caprylyl glycol00YIU5438UIACT
TOCOPHEROLR0ZB2556P8IACT
CHLORPHENESINI670DAL4SZIACT
XANTHAN GUMTTV12P4NEEIACT
EDETATE DISODIUM7FLD91C86KIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
MICAV8A1AW0880IACT
P-ANISIC ACID4SB6Y7DMM3IACT
PAEONIA LACTIFLORA ROOT3Z3866YW6PIACT
BISMUTH OXYCHLORIDE4ZR792I587IACT
FERRIC OXIDE RED1K09F3G675IACT
ADENOSINEK72T3FS567IACT
IRIS X GERMANICA NOTHOVAR. FLORENTINA ROOTM30XO5X4XDIACT
SODIUM HYDROXIDE55X04QC32IIACT
STANNIC OXIDEKM7N50LOS6IACT
.ALPHA.-HEXYLCINNAMALDEHYDE7X6O37OK2IIACT
BENZYL ALCOHOLLKG8494WBHIACT
HYDROXYCITRONELLAL8SQ0VA4YURIACT
BENZYL SALICYLATEWAO5MNK9TUIACT
LINALOOL, (+/-)-D81QY6I88EIACT
.BETA.-CITRONELLOL, (R)-P01OUT964KIACT
LIMONENE, (+)-GFD7C86Q1WIACT
GERANIOLL837108USYIACT

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
Loreal Paris Age Perfect Rosy Tone SPF 30 Renew and revive healthy tone Visibly younger-looking skinAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc1c83726b-f8ff-48d5-bf30-bc75e3fb149d2023-12-29WarningsExact identifier
ndc (package): 49967-394-01
ndc (package): 49967-394-02
ndc (product): 49967-394
ndc11 (package): 49967039402
ndc11 (package): 49967039401
spl id: 15a1837f-664f-4ad3-b69b-dbe212b09a9c
spl set id: 1c83726b-f8ff-48d5-bf30-bc75e3fb149d

Reported adverse events (FAERS/openFDA)#

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