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 14 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
UV RESTORE FACE SERUM SUNSCREEN SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE	COSMAX USA	564b8070-ee59-0c24-e063-6294a90ad9a9	2026-07-10	Warnings	Exact identifier application number: M020
COCO-EVE COCONUT MILK BODY SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	COSMAX USA	564b80c2-16e0-fb5f-e063-6394a90a50d2	2026-07-10	Warnings	Exact identifier application number: M020
COCO EVE SUNNY HONEY HIGHLIGHTER BODY SPF 50	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	COSMAX USA	564b9b1f-3d5b-4349-e063-6294a90a3b77	2026-07-10	Warnings	Exact identifier application number: M020
NORWEX Lip Glaze Broad Spectrum SPF 30 Hazelnut	ZINC OXIDE	COSMAX USA	564ba912-c44b-4940-e063-6294a90a28fa	2026-07-10	Warnings	Exact identifier application number: M020
MISTINE UV INVISIBLE FACE SHEER SUNSCREEN SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	COSMAX USA	564bbb5f-4000-390d-e063-6294a90a408d	2026-07-10	Warnings	Exact identifier application number: M020
PEACH AND LILY SUN COVER MINERAL SUNSCREEN SPF 30	ZINC OXIDE	COSMAX USA	564bb5f9-5ac5-548b-e063-6394a90a8462	2026-07-10	Warnings	Exact identifier application number: M020
ILLUSION LUMINOUS GLOW FOUNDATION	AVOBENZONE, HOMOSALATE, AND OCTISALATE	Kingdom Animalia, LLC DBA Hourglass Cosmetics	cf6a7e1a-7bca-439c-808a-80262f095f84	2026-07-10	Warnings	Exact identifier application number: M020
Tula Skincare Protect and Glow Daily Facial Sunscreen Gel SPF 30	AVOBENZONE, HOMOSALATE, AND OCTISALATE	The Procter & Gamble Manufacturing Company	30a063fa-e537-a2c1-e063-6394a90a6a83	2026-07-09	Warnings	Exact identifier application number: M020
Olay Complete Lightweight with Sunscreen Broad Spectrum SPF 15 Sensitive	OCTINOXATE AND ZINC OXIDE	The Procter & Gamble Manufacturing Company	3cb971e1-34f1-ee89-e063-6394a90a52a9	2026-07-09	Warnings	Exact identifier application number: M020
Olay Complete Lightweight with Sunscreen Broad Spectrum SPF 30 Sensitive	OCTINOXATE, OCTISALATE, OCTOCRYLENE, AND ZINC OXIDE	The Procter & Gamble Manufacturing Company	3cb9de81-f05e-9697-e063-6394a90a69c5	2026-07-09	Warnings	Exact identifier application number: M020
Bombee Honey Daily Glow Shield Sunscreen	HOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE	ABT ASIA Inc.	56112dff-b091-7a56-e063-6294a90a77d3	2026-07-08	Warnings	Exact identifier application number: M020
Sunny C Sunscreen SPF 50	SUNNY C SUNSCREEN	MIXIK, INC.	4ed2a482-6c63-69f5-e063-6394a90ad3ee	2026-07-08	Warnings	Exact identifier application number: M020
Ultra Violette Supreme Screen Broad Spectrum SPF 50	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Grace and Fire USA Inc.	24389324-19db-7eb5-e063-6394a90ad7fb	2026-07-08	Warnings	Exact identifier application number: M020
ANEW ULTIMATE DAY MULTI-PERFORMANCECREAM SPF 25 SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTINOXATE,OXYBENZONE	COSMAX USA, CORPORATION	562053d4-12bd-976e-e063-6394a90a59de	2026-07-08	Warnings	Exact identifier application number: M020
Stay Ageless Tinted Mineral Sunscreen	BROAD SPECTRUM SPF30	DERMIO DERMATOLOGY LLC	562f5b0d-6a10-305d-e063-6394a90a5980	2026-07-08	Warnings	Exact identifier application number: M020
Stay Ageless Tinted Mineral Sunscreen	BROAD SPECTRUM SPF30	Suzanne's Skin2soul LLC	562fbaa6-f93a-5ec4-e063-6294a90a9634	2026-07-08	Warnings	Exact identifier application number: M020
Sun Protection Mineral SPF 30	ZINC OXIDE	derma e	bf6474a7-a21f-49cb-86e6-e5c40dbd34c3	2026-07-08	Warnings	Exact identifier application number: M020
Aussie Betta Tallow Sunscreen SPF50 SPF50	TITANIUM DIOXIDE AND ZINC OXIDE SUNSCREEN	AUSSIE BETTA HEALTHY CARE PTY LTD	56007d82-ff5b-6c26-e063-6294a90a09b6	2026-07-07	Warnings	Exact identifier application number: M020
Bath and Body Works SPF Pink Dream	AVOBENZONE,HOMOSALATE,OCTISALATE	Bath & Body Works, Inc.	560785f5-9126-12ba-e063-6294a90ac946	2026-07-07	Warnings	Exact identifier application number: M020
Bath and Body Works SPF Sunkissed Berry	AVOBENZONE,HOMOSALATE,OCTISALATE	Bath & Body Works, Inc.	56078698-8655-12bd-e063-6294a90ad34c	2026-07-07	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