FDA.reportPublic FDA data

Renove ROYAL PERFECT BB Cream SPF 30

Manufacturer
YS Health Corp. | Kolmar Korea Co. Ltd.
Effective date
2013-10-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:37:08

Label at a glance#

ProductRenove ROYAL PERFECT BB SPF 30
Active ingredientTITANIUM DIOXIDE, OCTINOXATE
Label structure8 sections

Indications and uses

helps prevent sunburn if used as directed with other sun protection measure (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: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours 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...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium dioxide 8%
Octyl methoxycinnamate 3%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • if used as directed with other sun protection measure (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

on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

keep out of eyes.  Rinse with water to remove

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

  • apply liberally 15 minutes before sun exposure
  • reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
  • 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 shirts, pants, hats and sunglasses
  • Children under 6 years of age:  Ask a doctor

Other information

SPL UNCLASSIFIED SECTION

  • protect this product from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, cyclomethicone, glycerin, titanium dioxide, c12-15 alkyl benzoate, phenyl trimethicone, prunus amygdalus dulcis (sweet almond) oil, talc, butylene glycol dicaprylate/dicaprate , ethylhexyl methoxycinnamate, isopropyl palmitate, cetyl peg/ppg-10/1 dimethicone, niacinamide, dipentaerythrityl hexahydroxystearate/hexastearate/hexarosinate, zinc oxide, polyglyceryl-4 isostearate, magnesium sulfate, iron oxides(ci77492), disteardimonium hectorite, portulaca oleracea extract, vinyl dimethicone/methicone silsesquioxane crosspolymer, dimethicone/vinyl dimethicone crosspolymer, phenoxyethanol, trihydroxystearin, iron oxides(ci77491), methicone, iron oxides(ci77499), dimethicone, ethylhexylglycerin, fragrance, silica, tocopheryl acetate , royal jelly extract, , aluminum hydroxide, aluminum stearate, adenosine, aminopropyl dimethicone, polymethylsilsesquioxane

Questions?

OTC - QUESTIONS SECTION

Call 1-877-727-5530

Renove ROYAL PERFECT BB Cream SPF 30 40ml (60782-000-00)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Renove Tube Label 1Renove Tube Label 1Renove Tube Label 2Renove Tube Label 2Renove Carton LabelRenove Carton Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
d676a241-be05-4740-b3ee-1a5f2ed422d2Product name420180615
dd8bd48f-20d6-43c7-b471-3ae872868afaProduct name320180125
d41954ff-bc63-4b2c-aba0-9146707659d7Product name220151117

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60782-000-002019-11-27C16284748780-19855e2a2-385e-60a7-e053-dbdaa90a05bdRenove ROYAL PERFECT BB Cream SPF 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60782-000-00Renove ROYAL PERFECT BB SPF 301 in 1 BOXCREAM11
60782-000-00Renove ROYAL PERFECT BB SPF 3040 mL in 1 TUBECREAM401

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60782-000RENOVE ROYAL PERFECT BB SPF 30 (TITANIUM DIOXIDE, OCTINOXATE) CREAM [YS HEALTH CORP.]1Legacy NDC, 2 package rows20131004_14c4f628-11c5-4e04-9d52-bb204369e1e2.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD511
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JP1
OCTINOXATEACTIVE MOIETY4Y5P7MUD511
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JP1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L01
ADENOSINEINACTIVE INGREDIENTK72T3FS5671
ALKYL (C12-15) BENZOATEINACTIVE INGREDIENTA9EJ3J61HQ1
ALMOND OILINACTIVE INGREDIENT66YXD4DKO91
ALUMINUM HYDROXIDEINACTIVE INGREDIENT5QB0T2IUN01
ALUMINUM STEARATEINACTIVE INGREDIENTU6XF9NP8HM1
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATEINACTIVE INGREDIENT75D21FL1PI1
CYCLOMETHICONEINACTIVE INGREDIENTNMQ347994Z1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O1
DISTEARDIMONIUM HECTORITEINACTIVE INGREDIENTX687XDK09L1
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3P1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G6751
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRT1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F3571
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
ISOPROPYL PALMITATEINACTIVE INGREDIENT8CRQ2TH63M1
MAGNESIUM SULFATEINACTIVE INGREDIENTDE08037SAB1
NIACINAMIDEINACTIVE INGREDIENT25X51I8RD41
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1
PHENYL TRIMETHICONEINACTIVE INGREDIENTDR0K5NOJ4R1
POLYGLYCERYL-4 ISOSTEARATEINACTIVE INGREDIENT820DPX33S71
PURSLANEINACTIVE INGREDIENTM6S840WXG51
TALCINACTIVE INGREDIENT7SEV7J4R1U1
TRIHYDROXYSTEARININACTIVE INGREDIENT06YD7896S31
WATERINACTIVE INGREDIENT059QF0KO0R1
ZINC OXIDEINACTIVE INGREDIENTSOI2LOH54Z1

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
60782-00060782-000-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
TITANIUM DIOXIDE15FIX9V2JPACTIB
OCTINOXATE4Y5P7MUD51ACTIB
WATER059QF0KO0RIACT
CYCLOMETHICONENMQ347994ZIACT
GLYCERINPDC6A3C0OXIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
PHENYL TRIMETHICONEDR0K5NOJ4RIACT
ALMOND OIL66YXD4DKO9IACT
TALC7SEV7J4R1UIACT
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE75D21FL1PIIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
NIACINAMIDE25X51I8RD4IACT
ZINC OXIDESOI2LOH54ZIACT
POLYGLYCERYL-4 ISOSTEARATE820DPX33S7IACT
MAGNESIUM SULFATEDE08037SABIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
PURSLANEM6S840WXG5IACT
PHENOXYETHANOLHIE492ZZ3TIACT
TRIHYDROXYSTEARIN06YD7896S3IACT
FERRIC OXIDE RED1K09F3G675IACT
FERROSOFERRIC OXIDEXM0M87F357IACT
DIMETHICONE92RU3N3Y1OIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
ALUMINUM STEARATEU6XF9NP8HMIACT
ADENOSINEK72T3FS567IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 4 · 211 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357TABLET / ORAL2 mgExact identifier — unii candidate
10 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, CHEWABLE / ORAL202 mgExact identifier — unii candidate
35 equally ranked IID candidates
ALUMINUM STEARATEALUMINUM STEARATEU6XF9NP8HMTABLET / ORAL6 mgExact identifier — unii candidate
5 equally ranked IID candidates
ALMOND OILALMOND OIL66YXD4DKO9CREAM / TOPICAL2 %w/wExact identifier — unii candidate
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTCAPSULE, EXTENDED RELEASE / ORAL7 mgExact identifier — unii candidate
20 equally ranked IID candidates
TALCTALC7SEV7J4R1UGRANULE, FOR SUSPENSION / ORAL296 mgExact identifier — unii candidate
35 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS225 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / BUCCAL34 mgExact identifier — unii candidate
75 equally ranked IID candidates
ZINC OXIDEZINC OXIDESOI2LOH54ZINJECTION / SUBCUTANEOUS0.02 %w/vExact identifier — unii candidate
6 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET / BUCCAL0.4 mgExact identifier — unii candidate
21 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRAVENOUS33750 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, EMULSION / INTRAVENOUS24100 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / OPHTHALMIC12 mgExact identifier — unii candidate
75 equally ranked IID candidates
CYCLOMETHICONECYCLOMETHICONENMQ347994ZAEROSOL, FOAM / TOPICAL5.26 %w/wExact identifier — unii candidate
5 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357CAPSULE, DELAYED RELEASE / ORAL6 mgExact identifier — unii candidate
10 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357TABLET, COATED / ORALNAExact identifier — unii candidate
10 equally ranked IID candidates
TALCTALC7SEV7J4R1UELIXIR / ORAL4.5 mg/5mlExact identifier — unii candidate
35 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL2 mgExact identifier — unii candidate
20 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE / ORAL3487 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii candidate
75 equally ranked IID candidates
ISOPROPYL PALMITATEISOPROPYL PALMITATE8CRQ2TH63MAEROSOL / TOPICAL397 mgExact identifier — unii candidate
8 equally ranked IID candidates
ZINC OXIDEZINC OXIDESOI2LOH54ZINJECTION, SUSPENSION / SUBCUTANEOUSNAExact identifier — unii candidate
6 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675CAPSULE, COATED / ORAL0.12 mgExact identifier — unii candidate
21 equally ranked IID candidates
ALUMINUM STEARATEALUMINUM STEARATEU6XF9NP8HMOINTMENT / TOPICAL0.01 %w/wExact identifier — unii candidate
5 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675CAPSULE, DELAYED RELEASE / ORAL14 mgExact identifier — unii candidate
21 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTCAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
20 equally ranked IID candidates
ZINC OXIDEZINC OXIDESOI2LOH54ZSUPPOSITORY / RECTAL375 mgExact identifier — unii candidate
6 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, EXTENDED RELEASE / ORAL7 mgExact identifier — unii candidate
75 equally ranked IID candidates
ISOPROPYL PALMITATEISOPROPYL PALMITATE8CRQ2TH63MAEROSOL, SPRAY / TOPICAL397 mgExact identifier — unii candidate
8 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii candidate
6 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / AURICULAR (OTIC)25 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUPPOSITORY / RECTAL440 mgExact identifier — unii candidate
75 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL, FOAM / TOPICAL72 mgExact identifier — unii candidate
6 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYSTEM / TOPICAL18144 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET / ORAL42 mgExact identifier — unii candidate
75 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357CAPSULE / ORAL11 mgExact identifier — unii candidate
10 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDOUCHE / VAGINAL1 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET, EXTENDED RELEASE / ORAL15 mgExact identifier — unii candidate
20 equally ranked IID candidates
ZINC OXIDEZINC OXIDESOI2LOH54ZLOTION / TOPICAL16 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357POWDER, FOR SUSPENSION / ORALNAExact identifier — unii candidate
10 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRAMUSCULAR450 mgExact identifier — unii candidate
75 equally ranked IID candidates
TALCTALC7SEV7J4R1UGUM, CHEWING / BUCCALNAExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UGRANULE / ORAL322 mgExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, EXTENDED RELEASE / ORAL300 mgExact identifier — unii candidate
35 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE, DENTIFRICE / DENTAL18 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXELIXIR / ORAL5621 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION, CONCENTRATE / ORAL200 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
ZINC OXIDEZINC OXIDESOI2LOH54ZSOLUTION / RESPIRATORY (INHALATION)3.11 %w/vExact identifier — unii candidate
6 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET / SUBLINGUAL32.4 mgExact identifier — unii candidate
35 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, COATED / ORAL1 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION, EXTENDED RELEASE / ORAL2000 mgExact identifier — unii candidate
75 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, DELAYED RELEASE / ORAL349 mgExact identifier — unii candidate
35 equally ranked IID candidates
NIACINAMIDENIACINAMIDE25X51I8RD4INJECTION / INTRAVENOUS2.5 %w/vExact identifier — unii candidate
4 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXOINTMENT / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
TALCTALC7SEV7J4R1USUSPENSION, EXTENDED RELEASE / ORAL46 mgExact identifier — unii candidate
35 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPRAY, METERED / NASAL13 mgExact identifier — unii candidate
75 equally ranked IID candidates
CYCLOMETHICONECYCLOMETHICONENMQ347994ZSOLUTION / TOPICAL11.57 %w/vExact identifier — unii candidate
5 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCLOTH / TOPICAL0.05 mg/mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / DENTAL15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates

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
bc35985e-98b8-489e-bf73-7b6f3bc466de14c4f628-11c5-4e04-9d52-bb204369e1e22013-10-03WarningsExact identifier
spl id: bc35985e-98b8-489e-bf73-7b6f3bc466de
spl set id: 14c4f628-11c5-4e04-9d52-bb204369e1e2

Reported adverse events (FAERS/openFDA)#

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