FDA.reportPublic FDA data

Broad Spectrum SPF 30 Up The Anti

Product NDC
42485-005
11-digit product format
424850005
Labeler code
42485
Product ID
42485-005_0c5b3fe9-1841-0f34-e063-6294a90ad802
Type
HUMAN OTC DRUG
Nonproprietary name
TITANIUM DIOXIDE, ZINC OXIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
Biopelle, Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-11-14
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
32; 60 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Broad Spectrum SPF 30 Up The Anti
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE32 mg/mL
ZINC OXIDE60 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
15FIX9V2JPInternal UNII lookup
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
37506766-370e-4ae4-8dbe-915a763e7c55Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42485-005-01Broad Spectrum SPF 30 Up The Anti75 mL in 1 BOTTLECREAM7511

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JPBROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]5
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZBROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]5
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JPBROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]5
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZBROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]5
ALLANTOININACTIVE INGREDIENT344S277G0ZBROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]5
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XBROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]5
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933BROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]5
BORON NITRIDEINACTIVE INGREDIENT2U4T60A6YDBROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]5
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RABROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]5
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8BROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]5
C12-15 ALKYL BENZOATEINACTIVE INGREDIENTA9EJ3J61HQBROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]5
CAMELLIA SINENSIS WHOLEINACTIVE INGREDIENTC5M4585ZBZBROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]5
CAPRYLYL TRISILOXANEINACTIVE INGREDIENTQ95M2P1KJLBROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]5
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNBROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]5
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0RBROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]5
CYCLOMETHICONE 6INACTIVE INGREDIENTXHK3U310BABROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]5
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OBROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]5
DMDM HYDANTOININACTIVE INGREDIENTBYR0546TOWBROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]5
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LUBROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]5
ETHYLHEXYL PALMITATEINACTIVE INGREDIENT2865993309BROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]5
ETHYLPARABENINACTIVE INGREDIENT14255EXE39BROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]5
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675BROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]5
GLYCERININACTIVE INGREDIENTPDC6A3C0OXBROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]5
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4BROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]5
IODOPROPYNYL BUTYLCARBAMATEINACTIVE INGREDIENT603P14DHEBBROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]5
ISOBUTYLPARABENINACTIVE INGREDIENT0QQJ25X58GBROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]5
ISOHEXADECANEINACTIVE INGREDIENT918X1OUF1EBROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]5
MATRICARIA CHAMOMILLA WHOLEINACTIVE INGREDIENT2Z4LRR776SBROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]5
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TBROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]5
PANTHENOLINACTIVE INGREDIENTWV9CM0O67ZBROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]5
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RBROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]5
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TBROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]5
POLYHYDROXYSTEARIC ACID (2300 MW)INACTIVE INGREDIENTYXH47AOU0FBROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]5
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HBROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]5
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3BROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]5
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHBROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]5
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW)INACTIVE INGREDIENT1DXE3F3OZXBROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]5
SODIUM ANISATEINACTIVE INGREDIENTF9WFJ28MV9BROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]5
SODIUM LEVULINATEINACTIVE INGREDIENTVK44E1MQU8BROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]5
TRIETHOXYCAPRYLYLSILANEINACTIVE INGREDIENTLDC331P08EBROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]5
WATERINACTIVE INGREDIENT059QF0KO0RBROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42485-005BROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]11Current NDC, Legacy NDC, 1 package rows20231213_37506766-370e-4ae4-8dbe-915a763e7c55.zip

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 108 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
First Aid Beauty FAB Ultra Repair Face Moisturizer with Sunscreen Broad Spectrum SPF 30OCTOCRYLENE, AND ZINC OXIDEThe Procter & Gamble Manufacturing Companyf6801575-6081-7566-e053-2995a90a20a82025-12-18WarningsExact identifier
application number: M020
Olay Regenerist Regenerating with Sunscreen Broad Spectrum SPF 15AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company00280745-908b-468f-e063-6294a90aa12f2025-12-18WarningsExact identifier
application number: M020
OLAY Prime plus Protect Facial Sunscreen with Vitamin C SPF35 Matte FinishAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company10bd41ac-9b96-840d-e063-6394a90a98d92025-12-18WarningsExact identifier
application number: M020
Olay Glow plus Protect Sunscreen Dewy Glow SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONEThe Procter & Gamble Manufacturing Company10bc4127-7569-d0de-e063-6294a90a97bf2025-12-18WarningsExact identifier
application number: M020
First Aid Beauty FAB Hydrating Sunscreen Milk Broad Spectrum SPF 45AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company29645d90-a444-4090-e063-6294a90ac7e32025-12-18WarningsExact identifier
application number: M020
Skin On Skin BC Foundation SPF 40 - Tan GoldenOCTISALATE, HOMOSALATE, ZINC OXIDEYENSA Beauty, LLC46440bac-de69-e59c-e063-6394a90a76c02025-12-18WarningsExact identifier
application number: M020
FUSIDYNE DERMA TROUBLE Zinc Calming SunscreenZINC OXIDEDONG WHA PHARM. CO., LTD.46457c78-74d6-ea6a-e063-6294a90a24ac2025-12-18WarningsExact identifier
application number: M020
THE MUG GUARD Invisible Gel Suncare for FaceAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEDune Suncare, Inc.4646988c-1060-ed5f-e063-6394a90aa7652025-12-18WarningsExact identifier
application number: M020
Sage and Zinc Facial Hydrating SPF15ZINC OXIDEEmeis Cosmetics Pty Ltdccabd647-ecdd-7230-e053-2a95a90a7a962025-12-18WarningsExact identifier
application number: M020
Avail Facial Sunscreen SPF 25HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEEmeis Cosmetics Pty Ltd7be903e4-5f07-35b2-e053-2991aa0a13402025-12-17WarningsExact identifier
application number: M020
Mineral Sheer StickZINC OXIDESupergoop, LLC0beed72e-51df-d15a-e063-6394a90af5592025-12-17WarningsExact identifier
application number: M020
Sunscreen Lotion118mlZINC OXIDE 12%,TITANIUM DIOXIDE 6%, HOMOSALATE 14%,OCTISALATE 5%Foshan Sugar Max Cosmetics CO.,Ltd4620c41a-2188-00f5-e063-6394a90a613c2025-12-17WarningsExact identifier
application number: M020
Sunscreen CreamZINC OXIDE 15%,TITANIUM DIOXIDE 6%,HOMOSALATE 5%,OCTISALATE 4%Foshan Sugar Max Cosmetics CO.,Ltd46224dbe-a0fb-c242-e063-6394a90a26342025-12-17WarningsExact identifier
application number: M020
CAPTURE TOTALE C.E.L.L. ENERGY SUPER POTENT SERUM FOUNDATION BROAD SPECTRUM SPF 20 0NENSULIZOLE, OCTISALATEParfums Christian Dior31141a45-54e2-4463-ab42-4df56d9116502025-12-17WarningsExact identifier
application number: M020
Perricone High Potency Face Finishing and Firming MoisturizerTITANIUM DIOXIDE, ZINC OXIDETHG Beauty USA LLC2409cea1-7077-dc12-e063-6294a90a45582025-12-17WarningsExact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEGlow Advanced Skin and Body Care, LLC3635a073-5484-f96c-e063-6394a90adef52025-12-17Exact identifier
application number: M020
Mineral Sunscreen LipTITANIUM DIOXIDE, ZINC OXIDEGlow Advanced Skin and Body Care, LLC36362dc7-31d7-f766-e063-6294a90a129b2025-12-17Exact identifier
application number: M020
Mineral Sunscreen Non-TintedZINC OXIDEGlow Advanced Skin and Body Care, LLC3635e45b-6978-ac69-e063-6294a90a22ac2025-12-17Exact identifier
application number: M020
Prime and ProtectTITANIUM DIOXIDE, ZINC OXIDEShannon Cornelsen-Lewandowski36480f7f-37e8-decd-e063-6394a90ada602025-12-17Exact identifier
application number: M020
Prime and ProtectTITANIUM DIOXIDE, ZINC OXIDEShannon Cornelsen-Lewandowski364827bd-5781-eb53-e063-6394a90ab22f2025-12-17Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42485-005-014248500050175 mL in 1 BOTTLE (42485-005-01) 75 ml2017-12-190000-00-00NoNoCurrent