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 186 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
I.C. Industrial Sunscreen	ZINC OXIDE, OCTINOXATE, OXYBENZONE, AND OCTISALATE	R & R Lotion, Inc	b89d687a-7b36-4643-9817-765d4710ca60	2025-09-15	Warnings	Exact identifier application number: M020
Neutrogena Ultra Sheer Body Mist Sunscreen Broad Spectrum SPF 70	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Kenvue Brands LLC	97795f0e-d867-4e17-b7c9-ede08e7df70c	2025-09-12	Warnings	Exact identifier application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 36N Deep	ZINC OXIDE	DOLCE & GABBANA BEAUTY S.R.L.	2d05659c-57d2-4faf-ab67-1b8d68945aed	2025-09-12	Warnings	Exact identifier application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 37W Deep	ZINC OXIDE	DOLCE & GABBANA BEAUTY S.R.L.	5ff2b9e4-a778-4667-8c3c-3561317b374a	2025-09-12	Warnings	Exact identifier application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 39N Deep	ZINC OXIDE	DOLCE & GABBANA BEAUTY S.R.L.	bc4f909f-3e2c-4fd7-a129-3c2fac8259f0	2025-09-12	Warnings	Exact identifier application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 40C Deep	ZINC OXIDE	DOLCE & GABBANA BEAUTY S.R.L.	2dd9a30a-2cde-44c0-9350-3aeab9f7091b	2025-09-12	Warnings	Exact identifier application number: M020
Dolce and Gabbana Get Your Healthy Glowy Skin Bergamot Glow Primer Blueberry Nutri Tint	ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	e375412e-8685-49a2-b1b0-00ab114e14b7	2025-09-12	Warnings	Exact identifier application number: M020
Beach Club Mineral Sunscreen	ZINC OXIDE, OCTINOXATE, OXYBENZONE, AND OCTISALATE	R & R Lotion, Inc	d9aae241-229e-4123-abe9-99f74f5ab0b3	2025-09-12	Warnings	Exact identifier application number: M020
sunscreen	TITANIUM DIOXIDE(NANO)	Mingyu (guangdong) Cosmetics Technology Co., Ltd	3e6fe9f3-486b-bba7-e063-6294a90adf37	2025-09-10	Warnings	Exact identifier application number: M020
Zinc Oxide Titanium Oxide	ZINC OXIDE TITANIUM OXIDE	Hello Bello	3e66c234-a152-098e-e063-6394a90ab540	2025-09-10	Warnings	Exact identifier application number: M020
Basin Sun Stick SPF 30	AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE	Retail Concepts of Minnesota, Inc.	3e78026e-0a6a-9e67-e063-6294a90a1bca	2025-09-10	Warnings	Exact identifier application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 30N Medium Deep	ZINC OXIDE	DOLCE & GABBANA BEAUTY S.R.L.	428dac83-37dc-4b54-82e9-664f59f9af33	2025-09-10	Warnings	Exact identifier application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 31N Medium Deep	ZINC OXIDE	DOLCE & GABBANA BEAUTY S.R.L.	3174b962-12c0-43b4-8a9c-56fb044afd66	2025-09-10	Warnings	Exact identifier application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 34W Deep	ZINC OXIDE	DOLCE & GABBANA BEAUTY S.R.L.	c4135505-f0c5-4a91-91e2-ca0e38a0136c	2025-09-10	Warnings	Exact identifier application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 35W Deep	ZINC OXIDE	DOLCE & GABBANA BEAUTY S.R.L.	c5f65d27-4ad8-4188-98aa-0d9c2dd36180	2025-09-10	Warnings	Exact identifier application number: M020
Zinc Oxide Titanium Oxide	ZINC OXIDE TITANIUM OXIDE	Hello Bello	3e89d30e-b6cd-fabe-e063-6294a90a30ff	2025-09-10	Warnings	Exact identifier application number: M020
Ocean Potion Suncare 30 Continuous Sunscreen Scent of Sunshine	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	GNL BRANDS INTERNATIONAL, LLC	3e60bd44-1984-57c6-e063-6294a90a1f4e	2025-09-09	Warnings	Exact identifier application number: M020
Ocean Potion Suncare 70 Continuous Sunscreen Scent of Sunshine	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	GNL BRANDS INTERNATIONAL, LLC	3e60d362-4700-1042-e063-6394a90ab39f	2025-09-09	Warnings	Exact identifier application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 25W Medium Deep	ZINC OXIDE	DOLCE & GABBANA BEAUTY S.R.L.	3d2a702b-2ff6-473a-9ab1-823e0e53a8cf	2025-09-09	Warnings	Exact identifier application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 29W Medium Deep	ZINC OXIDE	DOLCE & GABBANA BEAUTY S.R.L.	285c9b63-ae65-4508-8bba-1541b3cc4380	2025-09-09	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