man's best friend

man's best friend
SPL v1
SPL
SPL Set ID 3eaeecc3-5d66-4f18-b2c0-0cd032352847
Route
topical
Published
Effective Date 2019-04-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
octinoxate (7 g) homosalate (3 g) octisalate (1.5 g) titanium dioxide
Inactive Ingredients
water pentylene glycol methylpropanediol caprylyl trisiloxane bemotrizinol isononyl isononanoate ethylhexyl triazone lauryl methacrylate/glycol dimethacrylate crosspolymer cyclomethicone 5 phenoxyethanol sodium acrylate/sodium acryloyldimethyltaurate copolymer (4000000 mw) isohexadecane aluminum hydroxide stearic acid dimethicone/vinyl dimethicone crosspolymer (soft particle) .alpha.-tocopherol acetate sorbitan isostearate ammonium acryloyldimethyltaurate/vp copolymer allantoin polysorbate 80 butylene glycol sorbitan monooleate butylated hydroxytoluene xanthan gum biosaccharide gum-4 hyaluronate sodium moringa oleifera seed oil ethylhexylglycerin green tea leaf glycyrrhiza glabra asian ginseng

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2019-05-01

Description

Octinoxate, Homosalate, Octisalate, titanium dioxide


Medication Information

Inactive Ingredients

Water, Pentylene Glycol, Methylpropanediol, Caprylyl Methicone, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Isononyl Isononanoate, Ethylhexyl Triazone, Lauryl Methacrylate/Glycol Dimethacrylate Crosspolymer, Cyclopentasiloxane, Phenoxyethanol, Sodium Acrylate/Sodium   Acryloyldimethyl Taurate Copolymer, Isohexadecane, Aluminium Hydroxide, Stearic Acid, Dimethicone/Vinyl Dimethicone Crosspolymer, Tocopheryl Acetate (Vitamin E), Sorbitan Isostearate, Ammoniumacryloyldimethyl Taurate/VP Copolymer, Allantoin, Polysorbate 80, Butylene Glycol, Sorbitan Oleate, BHT Xanthan Gum, Biosaccharide Gum-4, Sodium Hyaluronate, Moringa Seed Oil, Ethylhexylglycerin, Green Tea Extract, Licorice Root Extract, Panax Ginseng Root Extract, Fragrance

Description

Octinoxate, Homosalate, Octisalate, titanium dioxide

Principal Display Panel

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.

Section 50565-1

Section 55105-1

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 doctor if rash occurs. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions:

Apply liberally 15 minutes before sun exposure. Reapply every 2 hours and after swimming. Children under 6 months: Ask a doctor.

Sun Protection Measures: Sun exposure increases your risc of skin cancer and early skin aging. Use a sunscreen with a minium Broad Spectrum SPF15+ Limit time in the Sun, especially from 10 am - 2pm, wear hats, sunglasses, long-sleeve, clothing and pants. 

Active Ingredients

Octinoxate, Homosalate, Octisalate, titanium dioxide

Other Information:

Protect this product from excessive heat and direct sun.


Structured Label Content

Inactive Ingredients

Water, Pentylene Glycol, Methylpropanediol, Caprylyl Methicone, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Isononyl Isononanoate, Ethylhexyl Triazone, Lauryl Methacrylate/Glycol Dimethacrylate Crosspolymer, Cyclopentasiloxane, Phenoxyethanol, Sodium Acrylate/Sodium   Acryloyldimethyl Taurate Copolymer, Isohexadecane, Aluminium Hydroxide, Stearic Acid, Dimethicone/Vinyl Dimethicone Crosspolymer, Tocopheryl Acetate (Vitamin E), Sorbitan Isostearate, Ammoniumacryloyldimethyl Taurate/VP Copolymer, Allantoin, Polysorbate 80, Butylene Glycol, Sorbitan Oleate, BHT Xanthan Gum, Biosaccharide Gum-4, Sodium Hyaluronate, Moringa Seed Oil, Ethylhexylglycerin, Green Tea Extract, Licorice Root Extract, Panax Ginseng Root Extract, Fragrance

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

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.

Section 50565-1 (50565-1)

Section 55105-1 (55105-1)

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 doctor if rash occurs. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions:

Apply liberally 15 minutes before sun exposure. Reapply every 2 hours and after swimming. Children under 6 months: Ask a doctor.

Sun Protection Measures: Sun exposure increases your risc of skin cancer and early skin aging. Use a sunscreen with a minium Broad Spectrum SPF15+ Limit time in the Sun, especially from 10 am - 2pm, wear hats, sunglasses, long-sleeve, clothing and pants. 

Active Ingredients (Active ingredients)

Octinoxate, Homosalate, Octisalate, titanium dioxide

Other Information:

Protect this product from excessive heat and direct sun.


Advanced Ingredient Data


Raw Label Data

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