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 259 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zoey naturals Broad Spectrum SPF 50 Fragrance Free Sunscreen	ZINC OXIDE	Absolutely Natural	6e05e060-a531-4c4a-b273-889407ec5704	2024-12-11	Warnings	Exact identifier application number: M020
Peptide Lip Shine SPF30 Sunscreen	ZINC OXIDE	Colorescience, Inc.	98cdf19d-8b8a-4051-88bb-79160b2af39e	2024-12-11	Warnings	Exact identifier application number: M020
Zoey naturals Broad Spectrum SPF 50Plus Fragrance Free Sunscreen	ZINC OXIDE	Absolutely Natural	082983a4-7b98-489d-8ac2-a185923b86ba	2024-12-11	Warnings	Exact identifier application number: M020
Absolutely Natural Broad Spectrum SPF 50 Sunscreen	ZINC OXIDE	Absolutely Natural	89657538-904d-4908-ba7b-6f84706a8001	2024-12-11	Warnings	Exact identifier application number: M020
SISLEYA Global Anti-Age Hand care SPF 15	AVOBENZONE, OCTINOXATE, OCTISALATE	C.F.E.B. Sisley	cddf11b1-a89b-4b54-b228-55ba8147f022	2024-12-10	Warnings	Exact identifier application number: M020
SUNLEYA Age minimizing sun care SPF 15	AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE	C.F.E.B. Sisley	67498d45-0871-4806-8854-81d3e50c4b90	2024-12-10	Warnings	Exact identifier application number: M020
SUPER CREME SOLAIRE CORPS Body sun care SPF 15	AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE	C.F.E.B. Sisley	1c774aa7-8963-4221-b4b0-b894bd1b941f	2024-12-10	Warnings	Exact identifier application number: M020
Tinted Sunscreen Cream SPF 30 4-Deep Amber	TITANIUM DIOXIDE, ZINC OXIDE	C.F.E.B. - Sisley	5599922a-b020-477c-a44c-1db42ec5756a	2024-12-10	Warnings	Exact identifier application number: M020
SUNLEYA Age minimizing sun care SPF 50 plus	AVOBENZONE, HOMOSALTE, OCTISALATE, OCTOCRYLENE	C.F.E.B. Sisley	7c9fadaf-b961-4df0-89ae-87141b50b2c1	2024-12-10	Warnings	Exact identifier application number: M020
Tinted Sunscreen SPF 30 1-Natural	TITANIUM DIOXIDE, ZINC OXIDE	C.F.E.B. - Sisley	b3d53a10-2647-492a-a05f-b97c3f716aa8	2024-12-10	Warnings	Exact identifier application number: M020
Tinted Sunscreen SPF 30 2-Golden	TITANIUM DIOXIDE, ZINC OXIDE	C.F.E.B. - Sisley	389cbce6-552c-4633-babd-7b672632f0b9	2024-12-10	Warnings	Exact identifier application number: M020
BANANA BOAT	AVOBENZONE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	28f08236-1f01-d759-e063-6294a90adcfa	2024-12-10	Warnings	Exact identifier application number: M020
Blistex Five Star Lip Protection Broad Spectrum	HOMOSALATE, OCTISALATE, AVOBENZONE, AND DIMETHICONE	Blistex Inc.	47b57317-7df5-442e-a3a4-1d44fe278ac6	2024-12-10	Warnings	Exact identifier application number: M020
AHAVA Brightening Broad Spectrum SPF 20	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	AHAVA - Dead Sea Laboratories Ltd	724bbb91-e273-4926-9ad6-a1657ffe4cd8	2024-12-10	Warnings	Exact identifier application number: M020
ATTITUDE Sunly Mineral Sunscreen Stick Unscented SPF 30	ZINC OXIDE	9055-7588 Quebec Inc. DBA Attitude	0d83c576-5dfb-583a-e063-6294a90a2a28	2024-12-09	Warnings	Exact identifier application number: M020
ATTITUDE Sunly Kids Mineral Sunscreen Face Stick Unscented SPF 30	ZINC OXIDE	9055-7588 Quebec Inc. DBA Attitude	0d833e3b-5330-3c5b-e063-6394a90a2ed2	2024-12-09	Warnings	Exact identifier application number: M020
ATTITUDE Oatmeal Sensitive Natural Mineral Sunscreen Stick Unscented SPF 30	ZINC OXIDE	9055-7588 Quebec Inc. DBA Attitude	0d9533ba-5606-4116-e063-6294a90ad3b1	2024-12-09	Warnings	Exact identifier application number: M020
ATTITUDE Sunly Kids Mineral Sunscreen Stick Unscented SPF 30	ZINC OXIDE	9055-7588 Quebec Inc. DBA Attitude	0d82121d-1dc2-cd99-e063-6394a90aa766	2024-12-09	Warnings	Exact identifier application number: M020
Attitude Kids Oatmeal sensitive mineral sunscreen unscented SPF 30	ZINC OXIDE	9055-7588 Quebec Inc. DBA Attitude	310e66a2-8714-4016-87f4-81c1fef19ec9	2024-12-09	Warnings	Exact identifier application number: M020
Attitude Oatmeal sensitive mineral sunscreen unscented SPF 30	ZINC OXIDE	9055-7588 Quebec Inc. DBA Attitude	b6b8733d-6431-4ed2-9350-c63bb901c804	2024-12-09	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