Natural Mineral Formula

Manufacturer: Raining Rose, Inc.
Effective date: 2019-08-21
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 23:00:07

Label at a glance#

ProductNatural Mineral Formula

Active ingredientZINC OXIDE

Label structure13 sections

Indications and uses

Helps prevent sunburn

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACTS

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients:

Zinc Oxide (18.75%) Non-nanoparticle

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

Helps prevent sunburn

WARNINGS SECTION

Warnings

For External Use Only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - STOP USE SECTION

Stop use and as a doctor if • rash occurs

OTC - WHEN USING SECTION

When using this product • Keep out of eyes. Rinse well with water to remove.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

If swallowed, get medical help or call a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions •Apply liberally 15 minutes before sun exposure
• Reapply after 80 minutes of swimming or sweating, •Reapply
• immediately after towel drying. •Reapply at least every 2 hours
• Children under 6 months of age: Ask a doctor
Sun Protection Measures Spending time in the sun increases your
risk of skin cancer and early skin aging. To decrease this risk, regularly
use a sunscreen with a Broad Spectrum SPF value of 15 or higher and
other protection measures including:
• limit time in the sun, especially from 10a.m. - 2p.m.
• wear long sleeved shirts, pants, hat, and sunglasses.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Helianthus Annus (Sunflower) Seed Oil*, Cera Alba (Beeswax)*,

Simmondsia Chinensia (Jojoba) Seed Oil*, Cocos Nucifera (Coconut) Oil*,

non-GMO Tocopherol (Vitamin E).

*Organic Ingredients

OTHER SAFETY INFORMATION

Other Information: Protect this product from excessive heart and direct sun.

Product Package Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dist. by: Raining Rose, Inc., Cedar Rapids, IA 52403

Broad Spectrum SPF 30 Sunscreen

NATURAL MINERAL FORMULA

WATER RESISTANT

(80 MINUTES)

1.5 fl. oz. / 44 ml

L000000

Dist. by: Raining Rose Inc., Cedar Rapids, IA 52403

Broad Spectrum SPF 30 Sunscreen

NATURAL MINERAL FORMULA

Made in the USA

1.5 fl. oz. / 44 ml

L000000

SPF30 44mL Front

SPF30 44mL Back

rege

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
ZINC CATION Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f47a510b-6679-4664-b2d6-47b5c4afe7cc	Product name	4	20260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61c	Product name	2	20250515
0306390c-dd77-4363-afe0-63c58088b2a1	Product name	1	20220120
503ea967-4b9c-48cf-9e87-c7975295849d	Product name	2	20220120
190f2a5b-bbc8-65c7-fcb0-97891307b917	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
65692-0738-1	2021-01-29	C162847	48780-1	ba0f9c33-3219-a910-e053-dadaa90a0b85	Broad Spectrum SPF 30 NATURAL MINERAL FORMULA

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
65692-0738-1	Natural Mineral Formula	44 mL in 1 TUBE	LOTION	44		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65692-0738	NATURAL MINERAL FORMULA (ZINC OXIDE) LOTION [RAINING ROSE, INC.]	1	Legacy NDC, 1 package rows	20190822_c5de0eef-532c-4c29-9d92-07af28fddb69.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

Natural Mineral Formula
ZINC OXIDE
ZINC CATION
SUNFLOWER OIL
YELLOW WAX
JOJOBA OIL
COCONUT OIL
TOCOPHEROL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
65692-0738	65692-0738-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ZINC OXIDE	SOI2LOH54Z	ACTIM
SUNFLOWER OIL	3W1JG795YI	IACT
YELLOW WAX	2ZA36H0S2V	IACT
JOJOBA OIL	724GKU717M	IACT
COCONUT OIL	Q9L0O73W7L	IACT
TOCOPHEROL	R0ZB2556P8	IACT

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
dc16ccba-5997-46a9-a80f-c4a70c564d0d			c5de0eef-532c-4c29-9d92-07af28fddb69	2019-08-21	Warnings	Exact identifier spl id: dc16ccba-5997-46a9-a80f-c4a70c564d0d spl set id: c5de0eef-532c-4c29-9d92-07af28fddb69

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.