DERMATONE SPF 50- avobenzone, homosalate, octisalate, octocrylene lotion

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S), OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM), AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)

Available from:

Inspec Solutions LLC.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Uses • Helps prevent sunburn, higher SPF gives more sunburn protection • retains SPF after XX minutes of activity in the water or sweating • provides moderate protection against 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

Authorization status:

OTC monograph not final

Summary of Product characteristics

DERMATONE SPF 50- AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
LOTION
INSPEC SOLUTIONS LLC.
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may_
_be marketed if they comply with applicable regulations and policies.
FDA has not_
_evaluated whether this product complies._
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DERMATONE SPF 50 SUNSCREEN LOTION
Active ingredients
Avobenzone 3.0%
Homosalate 15.0%
Octisalate 5.0%
Octocrylene 10.0%
Uses
• Helps prevent sunburn, higher SPF gives more sunburn protection
• retains SPF after XX minutes of activity in the water or sweating
• provides moderate protection against 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.
Highly Flammable: Do not apply or use product near heat, flame, or
while smoking.
When using this product:
• keep out of eyes. Rinse with water to remove.
• Keep away from face to avoid breathing it.
• Do not puncture or incinerate, Contents under pressure
• Do not store at temperature above 120⁰F
Stop use and ask a doctor if rash occurs.
Keep out of reach of children. If swallowed, get medical help or
contact a Poison Control
Center right away
When using this product:
• keep out of eyes. Rinse with water to remove.
• Keep away from face to avoid breathing it.
• Do not puncture or incinerate, Contents under pressure
• Do not store at temperature above 120⁰F
Stop use and ask a doctor if rash occurs.
Keep out of reach of children. If swallowed, get medical help or
contact a Poison Control
Center right away
Behenyl Alcohol
BHT
Butyloctyl Salocylate
Caprylyl Methicone
Dimethicone
Dimethyl Capramide
Disodium EDTA
Ethylhexyl Stearate
Ethylhexylglycerin
Glyceryl Stearate
Hydrated Silicia
PEG-100 Stearate
Phenoxyethanol
Polyester-8
Sodium Polyacrylate
Styrene/ Acrylate Copolymer
Trideceth-6
Trimethylsiloxysilicate
VP/Hexadecene Copolyer
Water
Xanthan Gum
DIRECTIONS
• Apply liberally 15 minutes before sun