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 12 of 361 · 7,213 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sun Juice Body Mist Sunscreen SPF30 - Peach Sky PARADISO	AVOBENZONE, HOMOSALATE, OCTISALATE	Koco Life LLC	3cc48592-f70d-664e-e063-6294a90ac6e8	2026-07-13	Warnings	Exact identifier application number: M020
Sun Juice Body Mist Sunscreen SPF30 - Cotton Candy Skies PARADISO	AVOBENZONE, HOMOSALATE, OCTISALATE	Koco Life LLC	568083ff-0da9-7f14-e063-6394a90a4301	2026-07-13	Warnings	Exact identifier application number: M020
Sun Juice Body Mist Sunscreen SPF30 - Vanilla Breeze PARADISO	AVOBENZONE, HOMOSALATE, OCTISALATE	Koco Life LLC	3cc62c97-70c5-17f7-e063-6394a90abe25	2026-07-13	Warnings	Exact identifier application number: M020
Norwex Lip Glaze Broad Spectrum SPF 30 Rose	ZINC OXIDE	Norwex Usa, Inc.	565feded-8e25-e628-e063-6294a90aee48	2026-07-11	Warnings	Exact identifier application number: M020
PoutScreen Lip Treatment Lemon Meringue	AVOBENZONE, OCTINOXATE, OCTOCRYLENE	NAKED SUNDAYS PTY LTD	563e3ab9-4ee2-279c-e063-6294a90a7cf1	2026-07-10	Warnings	Exact identifier application number: M020
OMIC MINERAL SUNSCREEN	ZINC OXIDE	Mitchell Cosmetics, Inc	4bab742b-cc69-c582-e063-6394a90a4d54	2026-07-10	Warnings	Exact identifier application number: M020
INN BEAUTY SUN BALM SPF30 BROAD SPECTRUM LIP BALM - ROSY BROWN	ZINC OXIDE	COSMAX USA, CORPORATION	5643a73d-757c-702d-e063-6294a90a2c12	2026-07-10	Warnings	Exact identifier application number: M020
INN BEAUTY SUN BALM SPF30 BROAD SPECTRUM LIP BALM - LATTE	ZINC OXIDE	COSMAX USA, CORPORATION	5643d655-e335-5643-e063-6394a90a483a	2026-07-10	Warnings	Exact identifier application number: M020
MUSELY DAYCREAM SPF40	ZINC OXIDE	COSMAX USA, CORPORATION	56443156-3edb-a643-e063-6394a90adf9f	2026-07-10	Warnings	Exact identifier application number: M020
Hello Sun Silky Glow Broad Spectrum SPF40	ZINC OXIDE	Cosmax USA, Corporation	56445f2d-8e5a-34eb-e063-6294a90ae26e	2026-07-10	Warnings	Exact identifier application number: M020
Hello Kitty Fun Broad Spectrum SPF 40	ZINC OXIDE	Cosmax USA Corporation	5644854e-18d6-617d-e063-6294a90ab3e7	2026-07-10	Warnings	Exact identifier application number: M020
VERSED DAILY SUNSCREEN SPF 50	HOMOSALATE, OCTISALATE, AVOBENZONE	COSMAX USA, CORP	5644ca1e-9032-d3fb-e063-6394a90a961e	2026-07-10	Warnings	Exact identifier application number: M020
Hello Kitty Sunny Days Broad Spectrum SPF 40	ZINC OXIDE	Cosmax USA Corporation	5644855d-f864-e07b-e063-6394a90a5148	2026-07-10	Warnings	Exact identifier application number: M020
VERSED MULTI SERUM SKIN TINT SPF 40	ZINC OXIDE	COSMAX USA, CORP	5644d49f-08b9-e806-e063-6294a90a80f9	2026-07-10	Warnings	Exact identifier application number: M020
VERSED MULTI SERUM SKIN TINT SPF 40 LIGHT NEUTRAL	ZINC OXIDE	COSMAX USA, CORP	564682e5-1051-9936-e063-6394a90abe1d	2026-07-10	Warnings	Exact identifier application number: M020
VERSED MULTI SERUM SKIN TINT SPF 40 LIGHT WRM	ZINC OXIDE	COSMAX USA, CORP	5646e069-5461-12c5-e063-6294a90abacb	2026-07-10	Warnings	Exact identifier application number: M020
Protect Sport Sunscreen	BROAD SPECTRUM SPF 30	Opal Day Spa	564704f2-b26a-d737-e063-6294a90aa6ff	2026-07-10	Warnings	Exact identifier application number: M020
VERSED MULTI SERUM SKIN TINT SPF 40 LIGHT MEDIUM NEUTRAL	ZINC OXIDE	COSMAX USA, CORP	5647162a-610e-2789-e063-6294a90a7549	2026-07-10	Warnings	Exact identifier application number: M020
VERSED MULTI SERUM SKIN TINT SPF 40 LIGHT MEDIUM OLIVE	ZINC OXIDE	COSMAX USA, CORP	56472adb-572d-5a52-e063-6294a90a3cc3	2026-07-10	Warnings	Exact identifier application number: M020
VERSED MULTI SERUM SKIN TINT SPF 40 MEDIUM COOL	ZINC OXIDE	COSMAX USA, CORP	56474782-beff-8437-e063-6294a90a8322	2026-07-10	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