REVITALIZING MOISTURIZING SUNSCREEN CREAM - SPF-20

Manufacturer
GENOME COSMETICS, LLC | RNA PHARMA, LLC
Effective date
2013-10-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:43:28

Label at a glance#

ProductREVITALIZING MOISTURIZING Sunscreen SPF 20
Active ingredientOCTOCRYLENE, OCTINOXATE, AVOBENZONE
Label structure11 sections

Indications and uses

helps prevent sunburn

Dosage and administration

Gently massage onto all areas of the face using a circular motion 15 minutes prior to sun exposure Reapply every two hours For children under 6 months of age, ask a doctor Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

OCTOCRYLENE 10.0%

OCTINOXATE 7.5%

AVOBENZONE 3.0%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn

Warnings

WARNINGS SECTION

For external use only.

Do not apply to

  • irritated or broken skin.

Warnings

OTC - ASK DOCTOR SECTION

Consult a doctor

  • Stop use and consult a doctor if rash occurs.

Warnings

OTC - STOP USE SECTION

Stop use

  • Stop use and consult a doctor if 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

  • Gently massage onto all areas of the face using a circular motion 15 minutes prior

    to sun exposure

  • Reapply every two hours
  • For children under 6 months of age, ask a doctor
  • Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging.

Other Information

SPL UNCLASSIFIED SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water (AQUA, EAU), Helianthus Annuus Seed Oil, Cetearyl Alcohol, Limnanthes Alba, Carthamus Tinctorius (SAFFLOWER) Seed Oil, Meadowfoam Estolide, Polysorbate-60, Crambe Abyssinica Seed Oil, Simmondsia Chinesis (JOJOBA) Seed Oil, Meadowfoam Delta-Lactone, Olea Europaea (OLIVE) Oil Unsaponifiables, PEG-40 Hydrogenated Castor Oil, Meadowfoamamidopropyl Betaine, Dimethicone PEG-8 Meadowfoamate, Steareth-20, Polysorbate-65, Phenoxyethanol, Carbomer, Panthenol, Phytosterol, Aminomethylpropanol, CI15985 (YELLOW 6), Tocopheryl Acetate, Fragrance (Parfum), Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Cholecalciferol, Calendula Officinalis Flower Extract, Anthemis Nobilis (CHAMOMILE) Flower Extract, Beta Sitosterol, Tripeptide-10 Citrulline, Ubiquinone Q10, Sea Salt, Glycine Soja (Soybean) Oil, Oenothera Biennis (EVENING PRIMROSE) Oil (OMEGA-3), Borago Officinalis (BORAGE) Seed Oil (OMEGA-6), Aloe Barbadensis Leaf Juice, Algae Extract, Hippophae Rhamnoides (SEA BUCKTHORN) Extract. PARABEN-FREE

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DARK & BEAUTY REVITALIZING MOISTURIZING CREAM SPF-20

Manufactured for and exclusively distributed by:

Genome Cosmetics LLC

Bensalem, PA 19020 USA

Made in the U.S.A

Age Control LabelAge Control Label

Carton Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61791-126-012020-01-31C16284748780-19d75b9cf-d5da-f424-e053-dadaa90a57ceREVITALIZING MOISTURIZING SUNSCREEN CREAM - SPF-20

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61791-126-01REVITALIZING MOISTURIZING Sunscreen SPF 2050 g in 1 JARCREAM501
61791-126-01REVITALIZING MOISTURIZING Sunscreen SPF 201 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61791-126REVITALIZING MOISTURIZING SUNSCREEN SPF 20 (OCTOCRYLENE AND OCTINOXATE AND AVOBENZONE) CREAM [GENOME COSMETICS, LLC]1Legacy NDC, 2 package rows20150902_b8d39629-8729-44ae-97d6-bbb219e3bdfd.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOX1
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD511
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WM1
AVOBENZONEACTIVE MOIETYG63QQF2NOX1
OCTINOXATEACTIVE MOIETY4Y5P7MUD511
OCTOCRYLENEACTIVE MOIETY5A68WGF6WM1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L01
.BETA.-SITOSTEROLINACTIVE INGREDIENTS347WMO6M41
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X1
AMINOMETHYLPROPANOLINACTIVE INGREDIENTLU49E6626Q1
BORAGE OILINACTIVE INGREDIENTF8XAG1755S1
CALENDULA OFFICINALIS FLOWERINACTIVE INGREDIENTP0M7O4Y7YD1
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438U1
CARBOMER 940INACTIVE INGREDIENT4Q93RCW27E1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1S1
CHAMAEMELUM NOBILE FLOWERINACTIVE INGREDIENTO2T154T6OG1
CHOLECALCIFEROLINACTIVE INGREDIENT1C6V77QF411
CRAMBE HISPANICA SUBSP. ABYSSINICA SEED OILINACTIVE INGREDIENT0QW9S92J3K1
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3P1
EVENING PRIMROSE OILINACTIVE INGREDIENT3Q9L08K71N1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A81
GLYCINEINACTIVE INGREDIENTTE7660XO1C1
HEXYLENE GLYCOLINACTIVE INGREDIENTKEH0A3F75J1
HIPPOPHAE RHAMNOIDES FRUIT JUICEINACTIVE INGREDIENTUC3P08EB3Y1
JOJOBA OILINACTIVE INGREDIENT724GKU717M1
LIMNANTHES ALBA WHOLEINACTIVE INGREDIENTDKY81513ER1
MEADOWFOAM SEED OIL FATTY ACIDSINACTIVE INGREDIENTMK2D1PBV6N1
MEADOWFOAMAMIDOPROPYL BETAINEINACTIVE INGREDIENTHNV0L650LG1
MEADOWLACTONEINACTIVE INGREDIENT3OY5Q13U9R1
NORIINACTIVE INGREDIENT477TV3P5UX1
OLIVE OILINACTIVE INGREDIENT6UYK2W1W1E1
PANTHENOLINACTIVE INGREDIENTWV9CM0O67Z1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1
POLYOXYL 40 HYDROGENATED CASTOR OILINACTIVE INGREDIENT7YC686GQ8F1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4M1
POLYSORBATE 65INACTIVE INGREDIENT14BGY2Y3MJ1
SAFFLOWER OILINACTIVE INGREDIENT65UEH262IS1
SEA SALTINACTIVE INGREDIENT87GE52P74G1
SOYBEAN OILINACTIVE INGREDIENT241ATL177A1
STEARETH-20INACTIVE INGREDIENTL0Q8IK9E081
SUNFLOWER OILINACTIVE INGREDIENT3W1JG795YI1
TRIPEPTIDE-10 CITRULLINEINACTIVE INGREDIENT2732R0E76W1
UBIDECARENONEINACTIVE INGREDIENTEJ27X76M461
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 2 · 43 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61791-12661791-126-01

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 41 matching rows.

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 3 · 123 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
STEARETH-20STEARETH-20L0Q8IK9E08CREAM / TOPICAL4.15 %w/wExact identifier — unii candidate
GLYCINEGLYCINETE7660XO1CINJECTION / INTRAVENOUS200 mgExact identifier — unii candidate
20 equally ranked IID candidates
SOYBEAN OILSOYBEAN OIL241ATL177ACAPSULE / ORAL1318 mgExact identifier — unii candidate
7 equally ranked IID candidates
GLYCINEGLYCINETE7660XO1CSOLUTION / ORAL50 mgExact identifier — unii candidate
20 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8LOTION / TOPICALNAExact identifier — unii candidate
34 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8POWDER, FOR SUSPENSION / ORAL6 mgExact identifier — unii candidate
34 equally ranked IID candidates
GLYCINEGLYCINETE7660XO1CPOWDER, FOR SUSPENSION / ORAL400 mgExact identifier — unii candidate
20 equally ranked IID candidates
AMINOMETHYLPROPANOLAMINOMETHYLPROPANOLLU49E6626QLOTION / TOPICAL0.3 %w/wExact identifier — unii candidate
2 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8SOLUTION / RECTAL0.5 %w/vExact identifier — unii candidate
34 equally ranked IID candidates
AMINOMETHYLPROPANOLAMINOMETHYLPROPANOLLU49E6626QCREAM / TOPICAL1 %w/wExact identifier — unii candidate
2 equally ranked IID candidates
GLYCINEGLYCINETE7660XO1CINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS200 mgExact identifier — unii candidate
20 equally ranked IID candidates
HEXYLENE GLYCOLHEXYLENE GLYCOLKEH0A3F75JCREAM / TOPICAL385 mgExact identifier — unii candidate
4 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8TABLET, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
34 equally ranked IID candidates
GLYCINEGLYCINETE7660XO1CTABLET, ORALLY DISINTEGRATING / ORAL60 mgExact identifier — unii candidate
20 equally ranked IID candidates
POLYOXYL 40 HYDROGENATED CASTOR OILPOLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FTABLET, EXTENDED RELEASE / ORAL50 mgExact identifier — unii candidate
9 equally ranked IID candidates
SOYBEAN OILSOYBEAN OIL241ATL177AINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS10 %w/vExact identifier — unii candidate
7 equally ranked IID candidates
CARBOMER 940CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EGEL / OPHTHALMIC4 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MSUSPENSION / ORAL125 mgExact identifier — unii candidate
13 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ESOLUTION / ORAL425 mg/1mlExact identifier — unii candidate
5 equally ranked IID candidates
CARBOMER 940CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EEMULSION / TOPICAL6 mgExact identifier — unii candidate
9 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MSUSPENSION / TOPICAL2.85 %w/wExact identifier — unii candidate
13 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8CAPSULE, DELAYED RELEASE / ORAL0.02 mgExact identifier — unii candidate
34 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8SYRUP / ORAL4 mg/5mlExact identifier — unii candidate
34 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8CONCENTRATE / ORAL0.03 mg/5mlExact identifier — unii candidate
34 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MTABLET, COATED / ORALNAExact identifier — unii candidate
13 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ELOTION / TOPICAL32468 mgExact identifier — unii candidate
5 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8TABLET / SUBLINGUAL1 mgExact identifier — unii candidate
34 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8TABLET, CHEWABLE / ORAL0.41 mgExact identifier — unii candidate
34 equally ranked IID candidates
GLYCINEGLYCINETE7660XO1CINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR40 mgExact identifier — unii candidate
20 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8CAPSULE, COATED PELLETS / ORALNAExact identifier — unii candidate
34 equally ranked IID candidates
SOYBEAN OILSOYBEAN OIL241ATL177AINJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS223 mgExact identifier — unii candidate
7 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8CAPSULE, EXTENDED RELEASE / ORAL4.59 mgExact identifier — unii candidate
34 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MGUM, CHEWING / BUCCAL5 mgExact identifier — unii candidate
13 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8SOAP / TOPICAL0.2 %w/wExact identifier — unii candidate
34 equally ranked IID candidates
HEXYLENE GLYCOLHEXYLENE GLYCOLKEH0A3F75JGEL / TOPICAL280 mgExact identifier — unii candidate
4 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MAEROSOL, FOAM / TOPICAL30 mgExact identifier — unii candidate
13 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TGEL / TOPICAL14 mgExact identifier — unii candidate
6 equally ranked IID candidates
POLYOXYL 40 HYDROGENATED CASTOR OILPOLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FCAPSULE, COATED / ORAL101.25 mgExact identifier — unii candidate
9 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MEMULSION / ORAL20 mg/1mlExact identifier — unii candidate
13 equally ranked IID candidates
POLYOXYL 40 HYDROGENATED CASTOR OILPOLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FCAPSULE / ORAL3319 mgExact identifier — unii candidate
9 equally ranked IID candidates
GLYCINEGLYCINETE7660XO1CCAPSULE / ORAL62 mgExact identifier — unii candidate
20 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8ELIXIR / ORAL5.4 mg/5mlExact identifier — unii candidate
34 equally ranked IID candidates
GLYCINEGLYCINETE7660XO1CINJECTABLE, LIPOSOMAL / INTRAVENOUS0.38 %w/vExact identifier — unii candidate
20 equally ranked IID candidates
POLYOXYL 40 HYDROGENATED CASTOR OILPOLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FSOLUTION/ DROPS / OPHTHALMIC0.53 %w/vExact identifier — unii candidate
9 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
3 equally ranked IID candidates
POLYOXYL 40 HYDROGENATED CASTOR OILPOLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FCREAM / TOPICAL1 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8SPONGE / TOPICAL0.01 %w/wExact identifier — unii candidate
34 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii candidate
6 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8SOLUTION / ORAL75.3 mg/15mlExact identifier — unii candidate
34 equally ranked IID candidates
GLYCINEGLYCINETE7660XO1CTABLET / ORAL163.31 mgExact identifier — unii candidate
20 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8TABLET, ORALLY DISINTEGRATING / ORAL12 mgExact identifier — unii candidate
34 equally ranked IID candidates
SAFFLOWER OILSAFFLOWER OIL65UEH262ISLOTION / TOPICAL3510 mgExact identifier — unii candidate
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SAEROSOL, FOAM / TOPICAL21 mgExact identifier — unii candidate
9 equally ranked IID candidates
CARBOMER 940CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EGEL / TOPICAL85 mgExact identifier — unii candidate
9 equally ranked IID candidates
CARBOMER 940CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EGEL, METERED / TRANSDERMAL50 mgExact identifier — unii candidate
9 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ESOAP / TOPICALNAExact identifier — unii candidate
5 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
3 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SSUPPOSITORY / VAGINALNAExact identifier — unii candidate
9 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SCAPSULE, EXTENDED RELEASE / ORAL9.43 mgExact identifier — unii candidate
9 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MOINTMENT / TOPICAL2 %w/wExact identifier — unii candidate
13 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
55bcafbe-c613-4ab5-809d-d601838882b3b8d39629-8729-44ae-97d6-bbb219e3bdfd2013-10-22WarningsExact identifier
spl id: 55bcafbe-c613-4ab5-809d-d601838882b3
spl set id: b8d39629-8729-44ae-97d6-bbb219e3bdfd

Reported adverse events (FAERS/openFDA)#

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