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 273 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bali Body Cacao Tanning Oil SPF 15	OCTOCRYLENE, OCTISALATE, AVOBENZONE	Bali Body Pty Ltd	03c0b83d-0d85-9e69-e063-6394a90a6142	2024-10-21	Warnings	Exact identifier application number: M020
ALDI LACURA KIDS SPF 50 SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	ALDI INC	e34f37d7-02a5-0b72-e053-2a95a90acf83	2024-10-21	Warnings	Exact identifier application number: M020
Aldi Lacura Ultra Light Body SPF 100	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	ALDI INC	f7ac082c-def8-4379-e053-6294a90a57e3	2024-10-21	Warnings	Exact identifier application number: M020
Aldi LACURA Sport Sunscreen 30 Broad Spectrum SPF 30 Continuous	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	ALDI INC	f7bdc1f7-d961-4596-e053-6394a90a1d87	2024-10-21	Warnings	Exact identifier application number: M020
Aldi LACURA Ultra Light Dry-Touch 100 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	ALDI INC	f7b2cf4e-468c-3406-e053-6394a90a2139	2024-10-21	Warnings	Exact identifier application number: M020
Aldi LACURA Sport Sunscreen 50 Broad Spectrum SPF 50 Continuous	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	ALDI INC	f7b32aa8-2e56-3725-e053-6294a90a18d2	2024-10-21	Warnings	Exact identifier application number: M020
Bliss Block Star Sheer Liquid Daily Sunscreen SPF 50 SPF-50	ZINC OXIDE	Bliss Products Holdings LLC	f262e5a7-3c57-a6d8-e053-2995a90aacbc	2024-10-21	Warnings	Exact identifier application number: M020
Berkley Jensen Sport Sunscreen SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	BJWC	fbd65277-7aff-de19-e053-6394a90a9496	2024-10-21	Warnings	Exact identifier application number: M020
Sun Bum SPF 15 Premium Moisturizing Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	01bfe44c-655f-404c-981e-8d5f6728a738	2024-10-21	Warnings	Exact identifier application number: M020
Sun Bum SPF 70 Premium Moisturizing Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	aa612570-b70a-4910-8086-6634834beb70	2024-10-21	Warnings	Exact identifier application number: M020
Premium Moisturizing Sunscreen SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum LLC	f5bd673a-46e5-43d5-9d76-8ddc5da70146	2024-10-21	Warnings	Exact identifier application number: M020
Sun Bum Kids Sunscreen SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum LLC	6fcec9f9-bee0-4884-8c72-be273426f916	2024-10-21	Warnings	Exact identifier application number: M020
sunscreen	SKIN BARRIER SUN SHIELD SPF 30	True Botanicals, Inc.	d70eea23-7715-c17b-e053-2a95a90a839f	2024-10-18	Warnings	Exact identifier application number: M020
First Aid Only SunX30 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Acme United Corporation	24c22903-8911-81d9-e063-6394a90a108b	2024-10-18	Warnings	Exact identifier application number: M020
TiZO Eye Renewal SPF 20 (Non-Tinted)	ZINC OXIDE	Fallien Cosmeceuticals, LTD	33f8760c-2953-44a6-9239-424fdb97a5b3	2024-10-18	Warnings	Exact identifier application number: M020
Fruit of the Earth Sun Town City SPF 30 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Fruit of the Earth, Inc.	c85e5094-d442-55a9-e053-2995a90aed12	2024-10-18	Warnings	Exact identifier application number: M020
Bondi Sands SPF 60 Sunny Face	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	BONDI SANDS (USA) INC.	24c78897-3136-f24b-e063-6394a90aa80a	2024-10-18	Warnings	Exact identifier application number: M020
Fruit of the Earth Sun Town City Baby and Kids Mineral SPF 50 Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Fruit Of The Earth, Inc.	f42a0b1e-038d-4fab-e053-2995a90a5364	2024-10-18	Warnings	Exact identifier application number: M020
Cabana Beach Club with Manuka Honey and Essential Oils SPF 50 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Fruit of the Earth, Inc.	f451c472-1d9f-1fbc-e053-2995a90a114e	2024-10-18	Warnings	Exact identifier application number: M020
Fruit of the Earth Sun Town City Mineral SPF 30 Sunscreen	ZINC OXIDE	Fruit Of The Earth, Inc.	f4490608-6cce-90f3-e053-2995a90a4930	2024-10-18	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