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 74 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PROTEKT SPF-50 Sheer Mineral SunscreenZINC OXIDEProtekt Products, Inc.6edc0941-bb21-4797-a875-81f7276947742026-01-19WarningsExact identifier
application number: M020
Ultra Violette SPF Mini Mates Duo Pocket Pals Ultra Violette SPF Mini Mates Duo Pocket Pals Contains 1 X Supreme Screen SPF50 20mL (84803-100-21) 1 X Future Screen SPF50 20mL (84803-103-21)ACTIVE INGREDIENTS SUPREME SCREEN SPF 50 AVOBENZONE 3% HOMOSALATE 7% OCTISALATE 5% OCTOCRYLENE 8% ACTIVE INGREDIENTS FUTURE SCREEN SPF 50 ZINC OXIDE 20%Grace and Fire USA Inc.48c1b93c-9c6f-95aa-e063-6294a90a0cfa2026-01-19WarningsExact identifier
application number: M020
ANUA INVISIBLE GLOW FINISH SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEThe Founders Inc.446ac344-1078-4cd1-e063-6294a90a4bd42026-01-19WarningsExact identifier
application number: M020
ANUA ZERO-CAST MOISTURIZING FINISH SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEThe Founders Inc.31af7b5e-2bd6-63ee-e063-6294a90a08062026-01-19WarningsExact identifier
application number: M020
ANUA INVISIBLE MATTE FINISH SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEThe Founders Inc.4248deaf-ad55-a9b4-e063-6294a90a55cc2026-01-19WarningsExact identifier
application number: M020
ONSART Mineral SunscreenZINC OXIDE 24%Guangzhou Huixue Biotechnology Co., Ltd.48c9d08d-9a91-7df5-e063-6294a90a1c4a2026-01-19WarningsExact identifier
application number: M020
Intense Moisture Day CreamAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENECVS Health795d3546-f0dd-4b54-9807-9cdb3e6261812026-01-19WarningsExact identifier
application number: M020
CURESHIELD MANICURE SUNSCREENZINC OXIDE, TITANIUM DIOXIDEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD48b4fad7-073d-d983-e063-6394a90ae3142026-01-18WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 0CR Cool FosyOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior65ff0448-17e6-42ce-989a-940794fcbd8c2026-01-17WarningsExact identifier
application number: M020
BenzoAzeline 10BENZOYL PEROXIDENoon Aesthetics M.R. Ltd985efa19-bd91-45cd-a2a0-d71ec325e51c2026-01-16WarningsExact identifier
application number: M020
Prequel Lip Visor Berry SPF 30PREQUEL LIP VISOR BERRY SPF 30The Center Brands, LLCe4f3a0eb-4a8c-4145-92e4-979f03e3a5112026-01-16WarningsExact identifier
application number: M020
Prequel Lip Visor Blush SPF 30PREQUEL LIP VISOR BLUSH SPF 30The Center Brands, LLCbc681245-e158-4cfa-9718-7ec4cff0e60d2026-01-16WarningsExact identifier
application number: M020
Prequel Lip Visor Mahogany SPF 30PREQUEL LIP VISOR MAHOGANY SPF 30The Center Brands, LLCea8dcd14-3c54-46a6-aabc-3655f051065b2026-01-16WarningsExact identifier
application number: M020
Prequel Lip Visor Nude SPF 30PREQUEL LIP VISOR NUDE SPF 30The Center Brands, LLC03a7c77d-7b6e-4720-88f1-492ce57c71452026-01-16WarningsExact identifier
application number: M020
Valmont Daily Veil Moisturizing Face Fluid Mineral Sunscreen SPF 30ZINC OXIDECVL Cosmetics North America Incf3057856-1461-41d3-a5c4-9f12e3a4a0ee2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 6N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior04e9c4d8-1600-4ffc-8578-4ffb82b106f32026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior1d6f10b7-60b9-47f6-9dba-1dd0a7cf6f5d2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 5W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior1aae19da-1e73-41ed-91dc-0746ad311b872026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 6,5W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior22d4452d-3798-48c6-a7a4-4af0f99b4ebd2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 7N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diord6800bb7-16ef-48f6-a09a-0422e64ad8bd2026-01-16WarningsExact 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