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OTC products · Product label record

Ultra Violette Sheen Screen Broad Spectrum Hydrating Lip Balm Dusk drug information

SPF50
Grace And Fire USA Inc. · TOPICAL

Product NDC: 84803-104

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Source label information, not individualized medical advice. This record applies to the product and labeler shown below. Compare the exact formulation, strength and country with your package and the current source label.
Generic nameSPF50
Labeler / manufacturerGrace And Fire USA Inc.
RouteTOPICAL
Drug classDrug class not supplied in source label
Product NDC84803-104
Label effective date2026-10-01

Official product label reference

Ultra Violette Sheen Screen Broad Spectrum Hydrating Lip Balm Dusk — Grace And Fire USA Inc.

This page contains 9 source sections for SPF50, topical route. Label set 2735ab0f-5eec-04c5-e063-6394a90aa60e, version 5.

Retrieved 2026-10-02 · openFDA dataset updated 2026-10-02 · Check the current DailyMed label

Label records can cover multiple strengths or package sizes. A label listing does not by itself establish FDA approval or current market availability. Check the source and application history for this specific product.

Uses described in the label

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

Purpose

Purpose Sunscreen
Dosage and administration — label text
Directions * Apply liberally 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 10a.m.- 2p.m. • Wear long-sleeved shirts, pants, hats, and sunglasses • Children under 6 months of age: Ask a doctor
Warnings
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
Active ingredient
Active Ingredients Avobenzone 3% Octinoxate 5% Octocrylene 4.7%
When to stop use and seek help
Stop use and ask doctor if - rash occur
Child safety
Keep out of reach of children if swallowed , call a poison control centre or get medical help right away
Inactive ingredient
Inactive Ingredients Lanolin, Theobroma Cacao (Cocoa) Seed Butter, Cera Alba, Ricinus Communis (Castor) Seed Oil, Butyrospermum Parkii (Shea) Butter, Helianthus Annuus (Sunflower) Seed Oil, Olea Europaea (Olive) Fruit Oil, Flavour, Caprylic/Capric Triglyceride, Tocopherol, Myrothamnus Flabellifolia Leaf/Stem Extract, BHT, Limonene, Vanillin, Mentha Piperta Oil, Menthol, Titanium Dioxide (Cl 77891), Red 7 Lake (CI 15850), Iron Oxides (CI 77491), Iron Oxides (CI 77492), Iron Oxides (CI 77499)
Other safety information
Other Information Protect this product from excessive heat and direct sun

Official sources and product identifiers

Substances listed: OCTINOXATE, AVOBENZONE, OCTOCRYLENE

Package NDC codes

84803-104-01, 84803-104-02

Further research and background

These are external searches for related information. Research, encyclopedia and news articles have not been imported into this product record.

Coverage and corrections

The text is extracted from a US structured product label. Tables are represented as text where supplied; formatting and illustrations may be lost. A missing section does not mean a risk is absent. This reference has not been independently reviewed by a clinician and is not a live safety-alert service.

Source retrieved 2026-10-02. Read the source policy.