85966-004 U V-lamp Shield Mani-sunscreen

85966-004 U V-lamp Shield Mani-sunscreen
SPL v1
SPL
SPL Set ID 3fe7e1c3-e6cd-1420-e063-6394a90a4138
Route
TOPICAL
Published
Effective Date 2025-09-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (5 g) Zinc Oxide (10.15 g)
Inactive Ingredients
Ethylhexylglycerin Hydroxyacetophenone C12-15 Alkyl Benzoate Aluminum Hydroxide Cyclopentasiloxane Polymethylsilsesquioxane/trimethylsiloxysilicate Tocopherol Phenyl Trimethicone Vinyl Dimethicone/methicone Silsesquioxane Crosspolymer Phenoxyethanol Peg-10 Dimethicone (220 Cst) Stearic Acid Silica Triethoxycaprylylsilane Butylene Glycol Dimethicone Magnesium Sulfate Lauryl Peg-9 Polydimethylsiloxyethyl Dimethicone Disteardimonium Hectorite Polyhydroxystearic Acid (2300 Mw) Rosa Damascena Flower Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-29

Description

ZINC OXIDE 20.3% TITANIUM DIOXIDE 10%


Medication Information

Warnings and Precautions



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 occurs.

Keep out of reach of children. For external use only.

UV Lamp Specific Warning ·For maximum protection, reapply after hand washing or sweating during nail services.

Indications and Usage



Helps prevent sunburn.

lf used as directed with other sun protection measures (see DIRECTIONS), decreases the risk of skin cancer and early skin agingcaused by the sun

Desiqned to create a breathable barrier to shield hands from UVA and UVB radiation emitted during gel nail curing.

Dosage and Administration



1. Clean and dry your hands with thoroughly.

2. Apply a pearl-sized amountand spread evenly over hands, avoiding nails and cuticles.

3. Wait 5s for theproduct to form a matte film before beginning your nail art beauty.

4. Afternail lamp curing, simply wipe or rinse off any residue.

Tip: This sunscreen can also be applied daily for general U V protection. Forprolonged UV exposure (e.g., at a nail salon), reapply every 2 hours.

Description

ZINC OXIDE 20.3% TITANIUM DIOXIDE 10%

Section 50565-1

Keep out of reach of children.

Section 50566-9

Stop use and ask a doctor if · Rash occurs.

Section 50567-7

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

Section 50570-1

Do not use ·On damaged or broken skin.

Section 51727-6

ROSA DAMASCENA FLOWER WATER

BUTYLENE GLYCOL

HYDROXYACETOPHENONE

MAGNESIUM SULFATE

LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE

TOCOPHEROL

PEG-10 DIMETHICONE

C12-15 ALKYL BENZOATE

POLYHYDROXYSTEARIC ACID

TRIETHOXYCAPRYLYLSILANE

ALUMINUM HYDROXIDE

STEARIC ACID

CYCLOPENTASILOXANE

DISTEARDIMONIUM HECTORITE

DIMETHICONE

PHENYL TRIMETHICONE

SILICA

POLYMETHYLSILSESQUIOXANE

VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER

PHENOXYETHANOL

ETHYLHEXYLGLYCERIN

Section 51945-4

Section 55105-1

SUNSCREEN

Section 55106-9

ZINC OXIDE 20.3%

TITANIUM DIOXIDE 10%


Structured Label Content

Indications and Usage (34067-9)



Helps prevent sunburn.

lf used as directed with other sun protection measures (see DIRECTIONS), decreases the risk of skin cancer and early skin agingcaused by the sun

Desiqned to create a breathable barrier to shield hands from UVA and UVB radiation emitted during gel nail curing.

Dosage and Administration (34068-7)



1. Clean and dry your hands with thoroughly.

2. Apply a pearl-sized amountand spread evenly over hands, avoiding nails and cuticles.

3. Wait 5s for theproduct to form a matte film before beginning your nail art beauty.

4. Afternail lamp curing, simply wipe or rinse off any residue.

Tip: This sunscreen can also be applied daily for general U V protection. Forprolonged UV exposure (e.g., at a nail salon), reapply every 2 hours.

Warnings and Precautions (34071-1)



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 occurs.

Keep out of reach of children. For external use only.

UV Lamp Specific Warning ·For maximum protection, reapply after hand washing or sweating during nail services.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Stop use and ask a doctor if · Rash occurs.

Section 50567-7 (50567-7)

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

Section 50570-1 (50570-1)

Do not use ·On damaged or broken skin.

Section 51727-6 (51727-6)

ROSA DAMASCENA FLOWER WATER

BUTYLENE GLYCOL

HYDROXYACETOPHENONE

MAGNESIUM SULFATE

LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE

TOCOPHEROL

PEG-10 DIMETHICONE

C12-15 ALKYL BENZOATE

POLYHYDROXYSTEARIC ACID

TRIETHOXYCAPRYLYLSILANE

ALUMINUM HYDROXIDE

STEARIC ACID

CYCLOPENTASILOXANE

DISTEARDIMONIUM HECTORITE

DIMETHICONE

PHENYL TRIMETHICONE

SILICA

POLYMETHYLSILSESQUIOXANE

VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER

PHENOXYETHANOL

ETHYLHEXYLGLYCERIN

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

SUNSCREEN

Section 55106-9 (55106-9)

ZINC OXIDE 20.3%

TITANIUM DIOXIDE 10%


Advanced Ingredient Data


Raw Label Data

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