Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 13bc141b-a30f-2661-e063-6294a90aca2b
Route
TOPICAL
Published
Effective Date 2024-03-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (4.7 g) Zinc Oxide (6 g)
Inactive Ingredients
Acetyl Zingerone Polyglyceryl-4 Isostearate Sorbitan Olivate Pentaerythritol Tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) Potassium Sorbate Ferrosoferric Oxide Ferric Oxide Yellow Ethylhexylglycerin Tocopherol Phenoxyethanol Caprylyl Glycol Cyclomethicone 6 Benzoic Acid Phenylpropanol Magnesium Oxide Sodium Ferrocyanide Dimethicone Sodium Chloride Water Cetearyl Olivate Cetyl Peg/ppg-10/1 Dimethicone (hlb 4) Hexyl Laurate Medium-chain Triglycerides Green Tea Leaf Dipropylene Glycol Mannitol Methylpropanediol Ectoine Palmitic Acid Ferric Oxide Red Dimethicone/peg-10/15 Crosspolymer Sodium Citrate Haematococcus Pluvialis Aluminum Oxide Hexylene Glycol Stearic Acid Aluminum Hydroxide Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone .alpha.-tocopherol Acetate Tetrahexyldecyl Ascorbate Panthenol Vanilla Triethoxycaprylylsilane Sodium Benzoate Cyclomethicone 5 Alkyl (c12-15) Benzoate Glycerin Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Phosphatidylcholine Translocator Abcb4 Dimethicone/polyglycerin-3 Crosspolymer Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone (4000 Mpa.s)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-03-15

Description

Active ingredients Titanium Dioxide 4.7% Zinc Oxide 6.0%


Medication Information

Warnings and Precautions

Warnings • For external use only

Indications and Usage

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

Directions • apply generously 15 minutes before sun exposure • children under 6 months of age: Ask a doctor • reapply: • after 40 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • 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.

Description

Active ingredients Titanium Dioxide 4.7% Zinc Oxide 6.0%

Section 50565-1

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

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

Inactive ingredients: Agua/Water/Eau, Cyclopentasiloxane, C12-15 Alkyl Benzoate, Dimethicone, Glycerin, Cyclohexasiloxane, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Dimethicone /PEG-10/15 Crosspolymer, Aluminum Hydroxide, Stearic Acid, Sodium Chloride, Cetearyl Olivate, Acetyl Zingerone, PolyglyceryI-4 lsostearate, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, Dimethicone/Polyglycerin-3 Crosspolymer, Phenoxyethanol, Sorbitan Oliveto, Caprylic/Capric Triglyceride, Triethoxysilyethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Dimethicone/Vinyl Dimethicone Crosspolymer, Tocopheryl Acetate, Phosphatidylcholine, Mannitol, Vanilla Planifolia Fruit Extract, Camellia Sinensis Leaf Extract, Dipropylene Glycol, Benzoic Acid, Methyl Propanediol, Triethoxycapryiyisilane, Sodium Citrate, Ectoin, Stearic Acid, Palmitic Acid, Haematococcus Pluvialis Extract, Tocopherol, Tatrahexyldecyl Ascorbate, Panthenol, Phenylpropanol, Alumina, Magnesium Oxide, Sodium Benzoate, Potassium Sorbate, Pentaerythrityl Tetra-Di-T-Butyl Hydroxyhydrocinnamate, Sodium Ferrocyanide, CI 77891, CI 77499, CI 77492, CI 77491.

Section 51945-4

Section 55105-1

Purpose: Sunscreen

Section 55106-9

Active ingredients

Titanium Dioxide 4.7%

Zinc Oxide 6.0%

Section 60561-8

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


Structured Label Content

Indications and Usage (34067-9)

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 (34068-7)

Directions • apply generously 15 minutes before sun exposure • children under 6 months of age: Ask a doctor • reapply: • after 40 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • 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.

Warnings and Precautions (34071-1)

Warnings • For external use only

Section 50565-1 (50565-1)

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

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)

Inactive ingredients: Agua/Water/Eau, Cyclopentasiloxane, C12-15 Alkyl Benzoate, Dimethicone, Glycerin, Cyclohexasiloxane, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Dimethicone /PEG-10/15 Crosspolymer, Aluminum Hydroxide, Stearic Acid, Sodium Chloride, Cetearyl Olivate, Acetyl Zingerone, PolyglyceryI-4 lsostearate, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, Dimethicone/Polyglycerin-3 Crosspolymer, Phenoxyethanol, Sorbitan Oliveto, Caprylic/Capric Triglyceride, Triethoxysilyethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Dimethicone/Vinyl Dimethicone Crosspolymer, Tocopheryl Acetate, Phosphatidylcholine, Mannitol, Vanilla Planifolia Fruit Extract, Camellia Sinensis Leaf Extract, Dipropylene Glycol, Benzoic Acid, Methyl Propanediol, Triethoxycapryiyisilane, Sodium Citrate, Ectoin, Stearic Acid, Palmitic Acid, Haematococcus Pluvialis Extract, Tocopherol, Tatrahexyldecyl Ascorbate, Panthenol, Phenylpropanol, Alumina, Magnesium Oxide, Sodium Benzoate, Potassium Sorbate, Pentaerythrityl Tetra-Di-T-Butyl Hydroxyhydrocinnamate, Sodium Ferrocyanide, CI 77891, CI 77499, CI 77492, CI 77491.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose: Sunscreen

Section 55106-9 (55106-9)

Active ingredients

Titanium Dioxide 4.7%

Zinc Oxide 6.0%

Section 60561-8 (60561-8)

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


Advanced Ingredient Data


Raw Label Data

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