Calendula Essential Hydrating Broad Spectrum SPF 30 Sunscreen

Product NDC: 64657-007
11-digit product format: 646570007
Labeler code: 64657
Product ID: 64657-007_41d75815-e282-bf88-e063-6294a90afeff
Type: HUMAN OTC DRUG
Nonproprietary name: Zinc Oxide
Dosage form: LOTION
Route: TOPICAL
Labeler: Naturopathica Holistic Health
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2025-10-23
Substance: ZINC OXIDE
Active strength: 150 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: Calendula Essential Hydrating Broad Spectrum SPF 30 Sunscreen
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZINC OXIDE	150 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
41d75815-e281-bf88-e063-6294a90afeff	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d1c9d1af-bddd-448d-86f7-69052b7d5b47	Product name	1	20220627

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
64657-007-01	Calendula Essential Hydrating Broad Spectrum SPF 30 Sunscreen	65 mL in 1 TUBE	LOTION	65		1
64657-007-02	Calendula Essential Hydrating Broad Spectrum SPF 30 Sunscreen	1 in 1 CARTON	LOTION	1		1

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 297 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
RMS SUNCOVERUP SUPER TINT SPF 50 MAHOGANY	ZINC OXIDE	Rms organics LLC	1a1aebea-ed0c-ac92-e063-6294a90aeae6	2024-06-04	Warnings	Exact identifier application number: M020
Brush On Block SPF 30 Mineral Powder Translucent Zinc Only	ZINC OXIDE	SPF Ventures, LLC	1a1bf910-f1bc-bd75-e063-6294a90a663f	2024-06-04	Warnings	Exact identifier application number: M020
PROCEUTICALS PRIVATE LABEL by TiZO tinted mineral sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals, LTD	0b62062d-b77e-4e6c-b3ab-b35ab24db7cb	2024-06-04	Warnings	Exact identifier application number: M020
Protectif Deep Tint	ZINC OXIDE AND TITANIUM DIOXIDE	Derma Research Group Inc.	19b19023-1340-6609-e063-6394a90a6eaf	2024-05-30	Warnings	Exact identifier application number: M020
EltaMD UV Sport SPF50	ZINC OXIDE, OCTINOXATE AND OCTISALATE SUNSCREEN	CP Skin Health Group, Inc.	dffc3fde-5b6e-4a62-8289-9733be43455b	2024-05-30	Warnings	Exact identifier application number: M020
Vacation by Vacation Scent and Shimmer Duo	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Vacation Inc.	aef8388f-84bb-4e2b-8ae2-aa64f415a632	2024-05-28	Warnings	Exact identifier application number: M020
SPF50 Sunscreen Cariposa	ZINC OXIDE	Talent Brands Company LLC	1938fa13-875a-140e-e063-6294a90a5514	2024-05-24	Warnings	Exact identifier application number: M020
Derma E Vitamin C Weightless Moisturizer SPF 45	ZINC OXIDE	derma e	a3b404a6-e4b1-4c08-a8ef-77446dd2e411	2024-05-24	Warnings	Exact identifier application number: M020
COOLA Classic Liplux Lip Balm SPF 30 Original	AVOBENZONE, OCTISALATE, OCTOCRYLENE	COOLA, LLC	eeb420f0-c92f-0d96-e053-2a95a90afe36	2024-05-22	Warnings	Exact identifier application number: M020
COOLA Mineral Liplux Lip Balm SPF 30 Nude Beach	TITANIUM DIOXIDE, ZINC OXIDE	COOLA, LLC	ee2842c3-65e0-3904-e053-2a95a90aabff	2024-05-22	Warnings	Exact identifier application number: M020
COOLA Mineral Liplux Lip Balm SPF 30 Firecracker	TITANIUM DIOXIDE, ZINC OXIDE	COOLA, LLC	ee026a1c-885b-256f-e053-2a95a90af564	2024-05-22	Warnings	Exact identifier application number: M020
Bare Republic SPF 50 Mineral Sunscreen Vanilla Coco	TITANIUM DIOXIDE, ZINC OXIDE	COOLA, LLC	ec96dee8-85e8-3147-e053-2995a90aaf53	2024-05-22	Warnings	Exact identifier application number: M020
COOLA Rosilliance Mineral Tinted Face Moisturizer SPF 30 Bronze Goddess	TITANIUM DIOXIDE	COOLA, LLC	eeb406c6-a543-379a-e053-2995a90a4998	2024-05-22	Warnings	Exact identifier application number: M020
COOLA Rosilliance Mineral Tinted Face Moisturizer SPF 30 Fresh Rose	TITANIUM DIOXIDE	COOLA, LLC	ee01642f-478e-b307-e053-2a95a90a7d81	2024-05-22	Warnings	Exact identifier application number: M020
Bare Republic SPF 30 Mineral Sunscreen Coco Mango	ZINC OXIDE	COOLA, LLC	eca9ae89-19dc-516d-e053-2995a90a4698	2024-05-22	Warnings	Exact identifier application number: M020
Bare Republic Mineral Matte Untinted Face SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	COOLA, LLC	ecabcc89-fb09-41a9-e053-2995a90a8b31	2024-05-22	Warnings	Exact identifier application number: M020
Bare Republic Mineral Matte Tinted Face SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	COOLA, LLC	ee018c21-dca7-28aa-e053-2a95a90a3bdb	2024-05-22	Warnings	Exact identifier application number: M020
Bare Republic SPF 30 Mineral Sunscreen Citrus Cooler	ZINC OXIDE	COOLA, LLC	ecaad342-1873-60bc-e053-2995a90a5952	2024-05-22	Warnings	Exact identifier application number: M020
Bare Republic Mineral Shimmer SPF 30 Golden Daze	TITANIUM DIOXIDE, ZINC OXIDE	COOLA, LLC	eeb70034-0f8d-a46d-e053-2a95a90a8130	2024-05-22	Warnings	Exact identifier application number: M020
Bare Republic Mineral Shimmer SPF 30 Diamond Dust	TITANIUM DIOXIDE, ZINC OXIDE	COOLA, LLC	eec83ecb-d0ab-7857-e053-2995a90a40ed	2024-05-22	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
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	Sample	Exclude flag	Status
64657-007-01	64657000701	65 mL in 1 TUBE	65 ml				Historical
64657-007-02	64657000702	1 TUBE in 1 CARTON (64657-007-02) / 65 mL in 1 TUBE (64657-007-01)	1 tube	2025-10-23	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Zinc Oxide - Naturopathica Holistic Health	Naturopathica Holistic Health	2025-10-23	HUMAN OTC DRUG LABEL	1