Indications and uses
HELPS PREVENT SUNBURN IF USED AS DIRECTED WITH OTHER SUN PROTECTION MEASURES (SEE DIRECTIONS), DECREASES THE RISK OF SKIN CANCER AND EARLY SKIN AGING CAUSED BY THE SUN.
MINERAL SUNSCREEN
- Manufacturer
- Lee Indie & Co Inc
- Effective date
- 2023-01-10
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- full-release
- Hydrated at
- 2026-05-31 23:53:06
Label at a glance#
ProductMINERAL SUNSCREEN SPF 30
Active ingredientZINC OXIDE
Label structure10 sections
Dosage and administration
Shake before use. Apply generously to skin 15 minutes before sun exposure. During sun exposure, reapply: After 40 minutes of swimming or sweating Immediately after towel drying At least every two hours Sun Protection Measures Spending time in the sun increases the risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with broad spectrum SPF value of 15 or higher and other sun p...
Storage and handling
Protect this product from excessive heat and direct sun. Store below 90°F (32°C).
Contacts and useful links#
Label contents#
Full prescribing information#
ACTIVE INGREDIENT
ZINC OXIDE 20%
PURPOSE
SUNSCREEN
USES
- HELPS PREVENT SUNBURN
- IF USED AS DIRECTED WITH OTHER SUN PROTECTION MEASURES (SEE DIRECTIONS), DECREASES THE RISK OF SKIN CANCER AND EARLY SKIN AGING CAUSED BY THE SUN.
WARNINGS
FOR EXTERNAL USE ONLY.
DO NOT USE ON DAMAGED OR BROKEN SKIN.
WHEN USING THIS PRODUCT KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE.
STOP USE AND CONSULT A PHYSICIAN IF RASH OCCURS.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.
DIRECTIONS
Shake before use.
- Apply generously to skin 15 minutes before sun exposure.
- During sun exposure, reapply: After 40 minutes of swimming or sweating
- Immediately after towel drying
- At least every two hours
Sun Protection Measures Spending time in the sun increases the risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with broad spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10a.m. to 4 p.m.; wear long sleeve shirts, pants, hats and sunglasses. Children under 6 months: ask a doctor
INACTIVE INGREDIENTS
Water (aqua), Helianthus Annuus (Sunflower) Seed Oil, Caprylic/Capric Triglyceride, Squalane, Dicapryl Carbonate, Cetearyl Olivate, Sorbitan Olivate, Glycerin, Shea Butter Cetyl Esters, Sorbitan Sesquioleate, Polyhydroxystearic Acid, Diglycerin, Pinus Pinaster (Cluster Pine) Bark Extract, Punica Granatum (Pomegranate) Seed Oil, Phenethyl Alcohol, Pentylene Glycol, Propanediol, Aloe Barbadensis (Aloe Vera) Leaf Juice Powder, Panthenol, Xanthan Gum, Lauroyl Lysine
OTHER INFORMATION
Protect this product from excessive heat and direct sun. Store below 90°F (32°C).
QUESTIONS OR COMMENTS?
INDIELEE.COM
+1 (866) 488-1638 MON-FRI (9 A.M. - 5 P.M. EST)
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| ZINC CATION Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| 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 | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 81545-101-50 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-a101-d83d-e063-dadaa90ab31f | INDIE LEE - MINERAL SUNSCREEN SPF 30 (81545-101) |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 81545-101-10 | MINERAL SUNSCREENSPF 30 | 100 mL in 1 TUBE | LOTION | 100 | 5 | |
| 81545-101-50 | MINERAL SUNSCREENSPF 30 | 1 in 1 BOX | LOTION | 1 | 5 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- MINERAL SUNSCREEN SPF 30
- ZINC OXIDE
- MARITIME PINE
- POMEGRANATE SEED OIL
- ALOE VERA LEAF
- PANTHENOL
- XANTHAN GUM
- PHENYLETHYL ALCOHOL
- PENTYLENE GLYCOL
- PROPANEDIOL
- LAUROYL LYSINE
- MEDIUM-CHAIN TRIGLYCERIDES
- SORBITAN OLIVATE
- WATER
- SUNFLOWER OIL
- GLYCERIN
- SQUALANE
- DICAPRYLYL CARBONATE
- CETEARYL OLIVATE
- ZINC CATION
- DIGLYCERIN
- SHEA BUTTER ETHYL ESTERS
- SORBITAN SESQUIOLEATE
- POLYHYDROXYSTEARIC ACID (2300 MW)
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 81545-101 | 81545-101-10, 81545-101-50 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| f1f190da-554c-55cb-e053-2a95a90a2871 | cc37a6e8-3ce3-5eb4-e053-2995a90a217a | 2023-01-10 | Warnings | f1f190da-554c-55cb-e053-2a95a90a2871 cc37a6e8-3ce3-5eb4-e053-2995a90a217a |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.