Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID dd863361-281d-45fe-a8c1-6e4c670809a5
Route
TOPICAL
Published
Effective Date 2022-09-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (10 g) Octinoxate (5 g)
Inactive Ingredients
Ethyl Palmitate Neopentyl Glycol Dicaprylate/dicaprate Tridecyl Trimellitate Silicon Caprylic/capric/lauric Triglyceride Butylene Glycol Glycerin Polyglyceryl-3 Diisostearate Octyldodecanol Peg-30 Dipolyhydroxystearate Silica Dimethyl Silylate Phenoxyethanol Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (100000 Mpa.s At 1.5%) Isohexadecane Polysorbate 60 Caprylyl Glycol Ethylhexylglycerin Tetrahexyldecyl Ascorbate Water Alpha-tocopherol Polymethylsilsesquioxane (11 Microns) Dimethicone Triethoxycaprylylsilane Hexylene Glycol Camellia Oleifera Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-09-05

Description

Octinoxate 5% Titanium Dioxide 6.5%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Octinoxate 5% Titanium Dioxide 6.5%

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 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

• 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

Other Information

• protect the product in this container from excessive

heat and direct sun

Active Ingredients

Octinoxate 5%

Titanium Dioxide 6.5%

Inactive Ingredients

Aqua/Water/Eau, Ethyl Palmitate, Neopentyl Glycol Dicaprylate/Dicaprate, Tridecyl Trimellitate, Silica, Cyclopentasiloxane, Caprylic/Capric Trigylceride, HDI/Trimethylol Hexyllactone Crosspolymer, Butylene Glycol, Glycerin, Polyglyceryl-3 Diisostearate, Cyclohexasiloxane, Octyldodecanol, Octyldodecyl Xyloside, PEG-30 Dipolyhydroxystearate, Silica Dimethyl Siylate, Phenoxyethanol, Hydroxyethylacrylate/Sodium Acryloyldimethyl Tuarate Copolymer, Isohexadecane, Polysorbate 60, Caprylyl Glycol, Ethylhexyl Glycerin, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Polymethylsilsesquioxane, Dimethicone, Retinyl Palmitate, Triethoxycaprylylsilane, Hexylene Gylcol, Camellia Oleifera Leaf Extract, Diamond Powder, Titanium Dioxide, Iron Oxides

Principal Display Panel

Keep Out of Reach of Children

Keep out of reach of children


Structured Label Content

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

Sunscreen

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 docor if rash occurs



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

Directions

• 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

Other Information

• protect the product in this container from excessive

heat and direct sun

Active Ingredients

Octinoxate 5%

Titanium Dioxide 6.5%

Inactive Ingredients (Inactive ingredients)

Aqua/Water/Eau, Ethyl Palmitate, Neopentyl Glycol Dicaprylate/Dicaprate, Tridecyl Trimellitate, Silica, Cyclopentasiloxane, Caprylic/Capric Trigylceride, HDI/Trimethylol Hexyllactone Crosspolymer, Butylene Glycol, Glycerin, Polyglyceryl-3 Diisostearate, Cyclohexasiloxane, Octyldodecanol, Octyldodecyl Xyloside, PEG-30 Dipolyhydroxystearate, Silica Dimethyl Siylate, Phenoxyethanol, Hydroxyethylacrylate/Sodium Acryloyldimethyl Tuarate Copolymer, Isohexadecane, Polysorbate 60, Caprylyl Glycol, Ethylhexyl Glycerin, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Polymethylsilsesquioxane, Dimethicone, Retinyl Palmitate, Triethoxycaprylylsilane, Hexylene Gylcol, Camellia Oleifera Leaf Extract, Diamond Powder, Titanium Dioxide, Iron Oxides

Principal Display Panel

Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of children


Advanced Ingredient Data


Raw Label Data

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