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 310 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lancome Paris Absolue Bx Makeup Broad Spectrum SPF 18 Sunscreen Absolute Replenishing Radiant Makeup Normal to Dry Skin	OCTINOXATE	L'Oreal USA Products Inc	a45fef28-5dde-48b2-b7c0-ede694f4c32b	2023-12-30	Warnings	Exact identifier application number: M020
it cosmetics Bye Bye Foundation Full Coverage Moisturizer Broad Spectrum 50 Plus Sunscreen All Shades	TITANIUM DIOXIDE AND ZINC OXIDE	IT COSMETICS, LLC	34f0c2c9-a5bc-4b25-bfc1-336dcbb353e4	2023-12-30	Warnings	Exact identifier application number: M020
Kiehls Since 1851 Ultra Facial Broad Spectrum SPF 30 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	LOreal USA Products Inc	fb9daea3-c249-417c-ad34-3e89f3118559	2023-12-30	Warnings	Exact identifier application number: M020
Kiehls Since 1851 Broad Spectrum SPF 30 Sunscreen Powerful Wrinkle Reducing	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	3f58b258-b954-41f0-93ad-f6c9fe25718d	2023-12-30	Warnings	Exact identifier application number: M020
Kiehls Since 1851 Activated Sun Protector Broad Spectrum SPF 30 Sunscreen Water Resistant 80 MInutes	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE	L'Oreal USA Products Inc	2d2fbd8b-a90f-465a-9bf3-75cd6abdc6d3	2023-12-30	Warnings	Exact identifier application number: M020
Lancome Paris Renergie Lift MultiAction Ultra Firming and Dark Spot Correcting Moisturizer Broad Spectrum SPF 30 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	bf0e22df-4043-407f-a930-29595da1bdf6	2023-12-30	Warnings	Exact identifier application number: M020
Kiehls Since 1851 Activated Sun Protector Broad Spectrum SPF 50 Sunscreen Water Resistant 80 MInutes	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE	L'Oreal USA Products Inc	04fd0839-5046-4633-a919-6b7b6bea4f3e	2023-12-30	Warnings	Exact identifier application number: M020
Kiehls Since 1851 Dermatologist Solutions Super Fluid Daily UV Defense Broad Spectrum SPF 50 plus Sunscreen Antipollution Lightweight Formula	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	L'Oreal USA Products Inc.	ed138c48-d542-4522-a23c-1b586aad1127	2023-12-30	Warnings	Exact identifier application number: M020
Kiehls Since 1851 Ultra Facial Moisturizer Broad Spectrum SPF 30 Sunscreen For All Skin Types	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	d1a8c8d2-59d2-4389-9369-5f9b053a956e	2023-12-30	Warnings	Exact identifier application number: M020
Lancome Paris Visionnaire Broad Spectrum SPF 20 Sunscreen Advanced Multi Correcting All Skin Types	AVOBENZONE, OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	43041108-6adb-4dd3-a75f-87f5d643c794	2023-12-30	Warnings	Exact identifier application number: M020
Lancome Paris Bienfait MultiVital Eye Broad Spectrum SPF 30 Sunscreen	AVOBENZONE, OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	449a6027-4d0d-40e1-af58-3553071d6fdf	2023-12-30	Warnings	Exact identifier application number: M020
Carmex Daily Care Moisturizing Lip Balm Wintergreen SPF 15	OCTINOXATE, OXYBENZONE	Carma Laboratories, Inc.	baff2dfe-fd0b-0709-e053-2a95a90a431b	2023-12-29	Warnings	Exact identifier application number: M020
Carmex Daily Care Moisturizing Lip Balm Wintergreen SPF 15	OCTINOXATE, OXYBENZONE	Carma Laboratories, Inc.	bb013e70-f081-f8f2-e053-2995a90a1981	2023-12-29	Warnings	Exact identifier application number: M020
Loreal Paris Age Perfect Rosy Tone SPF 30 Renew and revive healthy tone Visibly younger-looking skin	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	1c83726b-f8ff-48d5-bf30-bc75e3fb149d	2023-12-29	Warnings	Exact identifier application number: M020
LOreal Paris True Match Lumi Healthy Luminous Makeup Broad Spectrum SPF 20	OCTINOXATE	L'Oreal USA Products Inc	cf39375c-de44-47de-bf15-fce4dfad8c74	2023-12-29	Warnings	Exact identifier application number: M020
Loreal Paris Age Perfect Radiant Serum foundation SPF 50	HOMOSALATE, OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	06a94c28-bfb7-4842-a463-459205477cd8	2023-12-29	Warnings	Exact identifier application number: M020
NUDESCREEN BLUSH TINT SPF 30 - PEACHES N SOL	ZINC OXIDE SUNSCREEN	Bentley Laboratories, LLC	e7c9c914-9972-4b55-a49d-cbc8ce075647	2023-12-29	Warnings	Exact identifier application number: M020
LOREAL PARIS REVITALIFT ANTI WRINKLE FIRMING MOISTURIZER SPF 25	AVOBENZONE, OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	8840da10-63cb-47ea-ad46-1ae6df1639e8	2023-12-29	Warnings	Exact identifier application number: M020
NUDESCREEN BLUSH TINT SPF 30 - PINK SUNRISE	ZINC OXIDE SUNSCREEN	Bentley Laboratories, LLC	289fb410-7884-4bc4-a25b-963de1cc3a70	2023-12-29	Warnings	Exact identifier application number: M020
LOreal Paris Infallible ProGlow Broad Spectrum SPF 15 Sunscreen	OCTINOXATE	L'Oreal USA Products Inc	82a6fbba-f0d4-475f-9ba7-615118eed70d	2023-12-29	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