Activated Mineral Sunscreen

Manufacturer
Reve Skincare LLC
Effective date
2025-03-25
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 20:40:14

Label at a glance#

ProductActivated Mineral Sunscreen
Active ingredientZINC OXIDE
Label structure11 sections

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

Dosage and administration

• apply generously 15 minutes before sun exposure • reapply: •at least every 2 hours. • use a water resistant sunscreen if swimming or sweating • 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 sun protection measures including: • limit time in the su...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 14.2%

Uses

INDICATIONS & USAGE SECTION

• 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

WARNINGS SECTION

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 docor if rash occurs

Keep out of reach of children. If swalled, get medical help or contact a Poison Control Center right away.

Directions

SPL UNCLASSIFIED SECTION

• apply generously 15 minutes before sun exposure
• reapply: •at least every 2 hours.

• use a water resistant sunscreen if swimming or sweating
• 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 sun protection measures including:
• limit time in the sun, especially from 10 a.m. - 2 p.m.
• wear long-sleeved shirts, pants, hats, and sunglasses
• children under 6 months of age: Ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Caprylic/Capric Triglyceride, Niacinamide, Butyloctyl Salicylate, Propanediol, Squalene, Aloe Barbadensis Leaf Juice, Sodium Acrylate/Sodium Acyloyldimethyl Tauarate Copolymer, 1,2-Hexanediol, Cetyl Alcohol, Glycol Stearate, Helianthus Annuus (Sunflower) Seed Oil, Hydroxyacetophenone, Polyisobutene, Glycerin, Glyceryl Stearate, Lecithin, Isostearic Acid, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Vaccinium Vitis-Idaea Fruit Extract, Xanthan Gum, Caprylyl/Capryl Glucoside, Sorbitan Oleate, Phenoxyethanol, Jojoba Esters, Citric Acid, Gluconolactone, Plankotn Extract, Alumina, Sodium Benzoate, Potassium Sorbate, Silica, Calcium Glucate. May Contain (+/-): Titanium Dioxide (CI77891), Iron Oxides (CI 774941, 77492, 77499)

Other Information

SPL UNCLASSIFIED SECTION

• protect the product in this container from excessive
heat and direct sun

Questions or Comments?

OTC - QUESTIONS SECTION

Call our Sunshine Concierge: 855-744-6366 (855-Shine-On)

Purpose

OTC - PURPOSE SECTION

Sunscreen

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Topical

DOSAGE & ADMINISTRATION SECTION

Topical

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

8308383083

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83083-001ACTIVATED MINERAL SUNSCREEN CREAM [REVE SKINCARE LLC]5Unmatched20250327_ec729c4f-c94c-1581-e053-2995a90a33d6.zip

Products#

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

DailyMed product names page 1 of 1 · 36 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83083-00183083-001-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 35 matching rows.

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
3129b046-9b57-5d40-e063-6294a90a706bec729c4f-c94c-1581-e053-2995a90a33d62025-03-25WarningsExact identifier
spl id: 3129b046-9b57-5d40-e063-6294a90a706b
spl set id: ec729c4f-c94c-1581-e053-2995a90a33d6

Reported adverse events (FAERS/openFDA)#

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