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
Ingredient	Strength
TITANIUM DIOXIDE	32 mg/mL
ZINC OXIDE	60 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
15FIX9V2JP	Internal UNII lookup
SOI2LOH54Z	Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
37506766-370e-4ae4-8dbe-915a763e7c55	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42485-005-01	Broad Spectrum SPF 30 Up The Anti	75 mL in 1 BOTTLE	CREAM	75		11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TITANIUM DIOXIDE	ACTIVE INGREDIENT	15FIX9V2JP	BROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	5
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	BROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	5
TITANIUM DIOXIDE	ACTIVE MOIETY	15FIX9V2JP	BROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	5
ZINC OXIDE	ACTIVE MOIETY	SOI2LOH54Z	BROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	5
ALLANTOIN	INACTIVE INGREDIENT	344S277G0Z	BROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	5
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	BROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	5
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	BROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	5
BORON NITRIDE	INACTIVE INGREDIENT	2U4T60A6YD	BROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	5
BUTYLENE GLYCOL	INACTIVE INGREDIENT	3XUS85K0RA	BROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	5
BUTYLPARABEN	INACTIVE INGREDIENT	3QPI1U3FV8	BROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	5
C12-15 ALKYL BENZOATE	INACTIVE INGREDIENT	A9EJ3J61HQ	BROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	5
CAMELLIA SINENSIS WHOLE	INACTIVE INGREDIENT	C5M4585ZBZ	BROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	5
CAPRYLYL TRISILOXANE	INACTIVE INGREDIENT	Q95M2P1KJL	BROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	5
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	BROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	5
CYCLOMETHICONE 5	INACTIVE INGREDIENT	0THT5PCI0R	BROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	5
CYCLOMETHICONE 6	INACTIVE INGREDIENT	XHK3U310BA	BROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	5
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	BROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	5
DMDM HYDANTOIN	INACTIVE INGREDIENT	BYR0546TOW	BROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	5
EDETATE SODIUM	INACTIVE INGREDIENT	MP1J8420LU	BROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	5
ETHYLHEXYL PALMITATE	INACTIVE INGREDIENT	2865993309	BROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	5
ETHYLPARABEN	INACTIVE INGREDIENT	14255EXE39	BROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	5
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	BROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	5
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	BROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	5
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	BROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	5
IODOPROPYNYL BUTYLCARBAMATE	INACTIVE INGREDIENT	603P14DHEB	BROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	5
ISOBUTYLPARABEN	INACTIVE INGREDIENT	0QQJ25X58G	BROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	5
ISOHEXADECANE	INACTIVE INGREDIENT	918X1OUF1E	BROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	5
MATRICARIA CHAMOMILLA WHOLE	INACTIVE INGREDIENT	2Z4LRR776S	BROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	5
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	BROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	5
PANTHENOL	INACTIVE INGREDIENT	WV9CM0O67Z	BROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	5
PEG-100 STEARATE	INACTIVE INGREDIENT	YD01N1999R	BROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	5
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	BROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	5
POLYHYDROXYSTEARIC ACID (2300 MW)	INACTIVE INGREDIENT	YXH47AOU0F	BROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	5
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	BROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	5
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	BROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	5
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	BROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	5
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW)	INACTIVE INGREDIENT	1DXE3F3OZX	BROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	5
SODIUM ANISATE	INACTIVE INGREDIENT	F9WFJ28MV9	BROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	5
SODIUM LEVULINATE	INACTIVE INGREDIENT	VK44E1MQU8	BROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	5
TRIETHOXYCAPRYLYLSILANE	INACTIVE INGREDIENT	LDC331P08E	BROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	5
WATER	INACTIVE INGREDIENT	059QF0KO0R	BROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42485-005	BROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]	11	Current NDC, Legacy NDC, 1 package rows	20231213_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 107 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SUNSCREEN SPRAY150mL	ZINC OXIDE 12%, TITANIUM DIOXIDE 6%, HOMOSALATE 14%, OCTISALATE 5%	Foshan Sugar Max Cosmetics CO.,Ltd	4635f90a-bbc9-0676-e063-6394a90a9f35	2025-12-18	Warnings	Exact identifier application number: M020
Sunscreen Stick	HOMOSALATE 15%, OCTISALLATE 5%, ENSULIZOLE 4%	Foshan Sugar Max Cosmetics CO.,Ltd	4637503c-46dc-68de-e063-6394a90abdc7	2025-12-18	Warnings	Exact identifier application number: M020
HAWAIIAN TROPIC SUNSCREEN SHEER TOUCH SPF 70	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	e78c9ae0-c2ef-12ce-e053-2995a90abf1c	2025-12-18	Warnings	Exact identifier application number: M020
NARS PURE RADIANT TINTED MOISTURIZER Cuzco	OCTINOXATE, TITANIUM DIOXIDE	NARS Cosmetics	5bb5d035-16d9-4843-b9aa-d30730c88508	2025-12-18	Warnings	Exact identifier application number: M020
Olay Regenerist Micro-Sculpting Hydrating Moisturizer Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	The Procter & Gamble Manufacturing Company	248be719-edff-f40d-e063-6394a90a4ef6	2025-12-18	Warnings	Exact identifier application number: M020
Olay Complete UV 365 Daily Moisturizer Normal Broad Spectrum SPF 15	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	The Procter & Gamble Manufacturing Company	59187729-c166-58fe-e053-2991aa0abe47	2025-12-18	Warnings	Exact identifier application number: M020
GM Collin SPF 25 UVA - UVB Urban Protection Veil Sunscreen	ZINC OXIDE AND TITANIUM DIOXIDE	Laboratoires Dermo-Cosmetik Inc.	4f0d44ca-09f0-4feb-b78c-77d83e75d4e2	2025-12-18	Warnings	Exact identifier application number: M020
Olay Complete UV365 Daily Moisturizer with Sunscreen Broad Spectrum SPF 30 Sensitive	OCTINOXATE, OCTISALATE, OCTOCRYLENE, AND ZINC OXIDE	The Procter & Gamble Manufacturing Company	60a304b1-eee5-408b-e053-2a91aa0a0a08	2025-12-18	Warnings	Exact identifier application number: M020
THE BOD GUARD Invisible Gel Sunscreen for Body	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Dune Suncare, Inc.	463fa1ef-d40d-d818-e063-6294a90a5e61	2025-12-18	Warnings	Exact identifier application number: M020
HAWAIIAN TROPIC SUNSCREEN CLEAR WEIGHTLESS HYDRATION SPF70	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	e686a22f-bddc-5d7c-e053-2995a90a7b28	2025-12-18	Warnings	Exact identifier application number: M020
HAWAIIAN TROPIC	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	090904d1-c04c-3fca-e063-6294a90a7cc7	2025-12-18	Warnings	Exact identifier application number: M020
Bye Bye Foundation Full Coverage Moisturizer SPF 50 Fair	TITANIUM DIOXIDE AND ZINC OXIDE	IT COSMETICS, LLC	b098aba3-dad6-4421-a943-e88ce5e2f8d6	2025-12-18	Warnings	Exact identifier application number: M020
it cosmetics Your Skin But Better CC Plus Color Correcting Broad Spectrum SPF 50 Plus Sunscreen Full Coverage Fair Ivory Fair Warm Fair Beige Medium Tan Warm Tan Rich Neutral Rich Neutral Deep Deep Bronze Deep Honey Deep Mocha	TITANIUM DIOXIDE AND ZINC OXIDE	IT COSMETICS, LLC	b3260833-8b7c-4d88-a55a-8cef4938442d	2025-12-18	Warnings	Exact identifier application number: M020
it cosmetics Your Skin But Better CC Plus Color Correcting Broad Spectrum SPF 50 Plus Sunscreen Full Coverage Medium Medium Tan Neutral Rich	TITANIUM DIOXIDE AND ZINC OXIDE	IT COSMETICS, LLC	0a647c9a-2c71-4cd2-9503-e9ab96b857ee	2025-12-18	Warnings	Exact identifier application number: M020
it cosmetics Your Skin But Better CC Plus Color Correcting Broad Spectrum SPF 50 Plus Sunscreen Full Coverage Fair Light LightMedium Medium Tan TanRich RichDeep	TITANIUM DIOXIDE AND ZINC OXIDE	IT COSMETICS, LLC	f246553e-17c2-4dba-855b-1942646bb834	2025-12-18	Warnings	Exact identifier application number: M020
it cosmetics Your Skin But Better CC Plus Color Correcting Broad Spectrum SPF 50 Plus Sunscreen Full Coverage Medium Tan Warm Neutral Rich Deep Bronze Neutral Deep Deep Bronze	TITANIUM DIOXIDE AND ZINC OXIDE	IT COSMETICS, LLC	15de58a4-e2bc-425b-b50b-df2d87dd3bb4	2025-12-18	Warnings	Exact identifier application number: M020
it cosmetics Your Skin But Better CC Plus Illumination Color Correcting Illuminating Broad Spectrum SPF 50 Plus Sunscreen Full Coverage FairLight NeutralTan RichHoney LightMedium and NeutralMedium	TITANIUM DIOXIDE AND ZINC OXIDE	IT COSMETICS, LLC	f493c3ea-41b3-4625-84a6-fab545a76940	2025-12-18	Warnings	Exact identifier application number: M020
YOUR SKIN BUT BETTER FAIR	TITANIUM DIOXIDE AND ZINC OXIDE	IT COSMETICS, LLC	472f34c5-cefe-4884-9475-fd0666c925ac	2025-12-18	Warnings	Exact identifier application number: M020
First Aid Beauty FAB Broad Spectrum Sunscreen SPF 30	OCTINOXATE, OCTOCRYLENE, AND ZINC OXIDE	The Procter & Gamble Manufacturing Company	d7238996-374b-07aa-e053-2995a90ae889	2025-12-18	Warnings	Exact identifier application number: M020
Olay Regenerist Hyaluronic plus Peptide 24 Hydrating Moisturizer with Sunscreen Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	The Procter & Gamble Manufacturing Company	eadacdae-3901-3f7c-e053-2a95a90ab184	2025-12-18	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
15FIX9V2JP	TITANIUM DIOXIDE	13463-67-7	TITANIUM DIOXIDE
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42485-005-01	42485000501	75 mL in 1 BOTTLE (42485-005-01)	75 ml	2017-12-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Broad Spectrum SPF 30 Up The Anti	Biopelle, Inc. \| Englewood Lab, Inc.	2023-12-12	HUMAN OTC DRUG LABEL	11