Broad Spectrum SPF 30 Up The Anti

Product NDC: 42485-005
Requested package NDC: 42485-005-01
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 231 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
JAFRA Beauty advanced SILK MOISTURIZING SERUM FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 RICH COCOA ND20	HOMOSALATE, OCTISALATE, ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	2e307ca4-9975-47ef-b13f-2cfbcc846719	2025-02-03	Warnings	Exact identifier application number: M020
JAFRA Beauty advanced SILK MOISTURIZING SERUM FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 CAPUCCINO D8	HOMOSALATE, OCTISALATE, ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	08628240-327d-4329-a0ff-fed239dde206	2025-02-03	Warnings	Exact identifier application number: M020
JAFRA Beauty advanced SILK MOISTURIZING SERUM FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 NATURAL LG14	HOMOSALATE, OCTISALATE, ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	768100d6-efd6-4a98-bdb8-2d1561ee356c	2025-02-03	Warnings	Exact identifier application number: M020
JAFRA Beauty advanced SILK MOISTURIZING SERUM FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 IVORY LN18	HOMOSALATE, OCTISALATE, ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	e6f33ec7-691f-4d4b-9086-b981c19f80d3	2025-02-03	Warnings	Exact identifier application number: M020
JAFRA Beauty advanced SILK MOISTURIZING SERUM FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 SUNTAN MDG14	HOMOSALATE, OCTISALATE, ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	784bb8c4-ee3c-4a73-a828-5781f01f621d	2025-02-03	Warnings	Exact identifier application number: M020
Brush On Block SPF 30 Mineral Powder Translucent Zinc Only-Refill	ZINC OXIDE	SPF Ventures, LLC	2d47eb76-e644-4e04-e063-6294a90a93cc	2025-02-03	Warnings	Exact identifier application number: M020
Brush On Block Sun Shine SPF 30 Protective Lip Oil Peony Tint	TITANIUM DIOXIDE/ZINC OXIDE	SPF Ventures LLC	2d490531-af36-87d0-e063-6394a90acf49	2025-02-03	Warnings	Exact identifier application number: M020
YOUR TINTED MOISTURIZER HYDRATING ANTI AGING BROAD SPECTRUM SPF 30	OCTISALATE, OCTINOXATE, OXYBENZONE, AVOBENZONE	Skin Ai, LLC	2d8b7d07-2249-898b-e063-6394a90af6ad	2025-02-01	Warnings	Exact identifier application number: M020
ESSENCE LIGHT SUNSCREEN SPF 50 PA	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	ENGLEWOOD LAB, INC.	f5c79f1a-cecd-2409-e053-2995a90ad06f	2025-01-31	Warnings	Exact identifier application number: M020
RODAN - FIELDS ESSENTIALS Body Sunscreen BROAD SPECTRUM SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Rodan & Fields	67b55df8-9623-4352-b136-b0bc8d1efe02	2025-01-31	Warnings	Exact identifier application number: M020
Oil-Free Daily Hydration SPF 15	OCTINOXATE, AVOBENZONE	Boscia LLC	ec322ae5-ab03-4c7b-9c6d-0bda3327c72a	2025-01-31	Warnings	Exact identifier application number: M020
PAULAS CHOICE HYDRALIGHT SHINE-FREE DAILY MINERAL COMPLEX Broad Spectrum SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Paula's Choice, Inc	b90658d0-e422-4265-a6ee-39c29b6c116a	2025-01-31	Warnings	Exact identifier application number: M020
SunStation USA SPF-30 SPORT SUNSCREEN	ZINC OXIDE	RENU LABORATORIES, LLC	11d3c60e-238d-999e-e063-6394a90a624b	2025-01-31	Warnings	Exact identifier application number: M020
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF30	TITANIUM DIOXIDE AND ZINC OXIDE	DERM ASSO. MID OHIO	2d04bc5d-6f11-4f56-e063-6294a90ae755	2025-01-31	Warnings	Exact identifier application number: M020
TiZO Mineral Sun Defense SPF 50	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals Ltd.	2d0766a1-4091-e84a-e063-6394a90a004a	2025-01-31	Warnings	Exact identifier application number: M020
Hello Sunday The Shimmer One Mineral Glow SPF 45	ZINC OXIDE	Kao USA Inc.	0c935521-4e8b-0605-e063-6394a90a0bbc	2025-01-31	Warnings	Exact identifier application number: M020
Hello Sunday The Invisible One Sunscreen Plus Primer SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Kao USA Inc.	0c7ce5b9-5ab4-d845-e063-6394a90afa76	2025-01-31	Warnings	Exact identifier application number: M020
Hello Sunday The Mineral One Lightweight Serum SPF 50	ZINC OXIDE	Kao USA Inc.	0c91894f-a40e-73e9-e063-6394a90ab807	2025-01-31	Warnings	Exact identifier application number: M020
Hello Sunday The One Thats a Serum Hydrating Serum SPF 45	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Kao USA Inc.	0c913096-c000-4336-e063-6394a90a560c	2025-01-31	Warnings	Exact identifier application number: M020
Hello Sunday Bestseller Daily SPF Duo	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Kao USA Inc.	26cf264b-f68d-5691-e063-6394a90a8ab4	2025-01-31	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