Indications and uses
Helps prevent sunburn. Higher SPF gives more sunburn protection 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
BLUE MONARCH Tinted SPF-50 (Rose Gold)
- Manufacturer
- Blue Monarch, LLC
- Effective date
- 2023-11-11
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 00:00:12
Label at a glance#
ProductBLUE MONARCH Tinted SPF-50 (Rose Gold)
Active ingredientZINC OXIDE
Label structure8 sections
Dosage and administration
Apply liberally 15 minutes before sun exposure and as needed. Children under 6 months of age: ask a doctor. Reapply at least every 2 hours Use a water-resistant sunscreen if swimming or sweating Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including: Sun Pro...
Contacts and useful links#
Label contents#
Full prescribing information#
Active Ingredients
Zinc Oxide 18.00%
Purpose
Sunscreen
Uses:
- Helps prevent sunburn.
- Higher SPF gives more sunburn protection
- 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 ask a doctor if
- rash or irritation developsand
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
If pregnant or breast-feeding,
ask a health professional before use
Directions:
- Apply liberally 15 minutes before sun exposure and as needed.
- Children under 6 months of age: ask a doctor.
- Reapply at least every 2 hours
- Use a water-resistant sunscreen if swimming or sweating
- Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including: Sun Protection Measures.
- Limit time in the sun, especially from 10 a.m. - 2 p.m.
- Wear long-sleeved shirts, pants, hats, and sunglasses.
Other Information:
- Protect the product in this container from excessive heat and direct sun.
Inactive Ingredients
Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, C12-15 Alkyl Benzoate, C18-21 Alkane, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Caprylyl Glycol, Citric Acid, Citrullus Lanatus (Watermelon) Extract, Cocos Nucifera (Coconut) Oil, Decyl Glucoside, Dodecane, Glycerin, Glyceryl Laurate, Glyceryl Stearate, Glyceryl Undecylenate, Iron Oxides (Black, Red, Yellow), Mangifera lndica (Mango) Butter, Punica Granatum (Pomegranate) Extract, Ricinus Communis (Castor) Oil, Sorbitan Stearate, Stearic Acid, Tocopheryl Acetate (Vitamin E), Vaccinium Angustifolium (Blueberry) Extract, Xanthan Gum, Zemea (Corn) Propanediol.
Questions?
(617) 943-0951
Package Labeling:
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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 72101-419-00 | BLUE MONARCH Tinted SPF-50 (Rose Gold) | 1 in 1 BOX | CREAM | 1 | 2 | |
| 72101-419-00 | BLUE MONARCH Tinted SPF-50 (Rose Gold) | 35 mL in 1 BOTTLE | CREAM | 35 | 2 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- BLUE MONARCH Tinted SPF-50 (Rose Gold)
- ZINC OXIDE
- ALOE VERA LEAF
- WATER
- BUTYLOCTYL SALICYLATE
- SHEA BUTTER
- ALKYL (C12-15) BENZOATE
- C18-C21 ALKANE
- GREEN TEA LEAF
- MEDIUM-CHAIN TRIGLYCERIDES
- CAPRYLYL GLYCOL
- CITRIC ACID MONOHYDRATE
- WATERMELON
- COCONUT OIL
- DECYL GLUCOSIDE
- DODECANE
- GLYCERIN
- GLYCERYL LAURATE
- GLYCERYL MONOSTEARATE
- FERRIC OXIDE RED
- MANGO
- PUNICA GRANATUM ROOT BARK
- CASTOR OIL
- SORBITAN MONOSTEARATE
- STEARIC ACID
- .ALPHA.-TOCOPHEROL ACETATE
- BLUEBERRY
- XANTHAN GUM
- CORN
- ZINC CATION
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 72101-419 | 72101-419-00 |
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 |
|---|---|---|---|---|---|---|
| BLUE MONARCH Tinted SPF-50 (Rose Gold) | ZINC OXIDE | Blue Monarch, LLC | 9ba00a03-1015-4946-8c9b-5ef377a32e4b | 2023-11-11 | Warnings | 72101-419-00 72101-419 72101041900 09dc64a4-8580-ddca-e063-6294a90ab8f1 9ba00a03-1015-4946-8c9b-5ef377a32e4b |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.