2 IN 1 SUNSCREEN AND GRADUAL SELF-TANNER- avobenzone, homosalate, octisalate, octocrylene aerosol, spray

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX), HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S), OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W), OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)

Available from:

Sunless, Inc

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Uses • 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 • retains SPF after 80 minutes activity in the water, sweating or perspiring • provides high protection against sunburn Stop use and ask a doctor if: rash or irritation develop and lasts

Authorization status:

OTC monograph final

Summary of Product characteristics

2 IN 1 SUNSCREEN AND GRADUAL SELF-TANNER- AVOBENZONE, HOMOSALATE,
OCTISALATE,
OCTOCRYLENE AEROSOL, SPRAY
SUNLESS, INC
_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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2 IN 1 SUNSCREEN AND GRADUAL SELF-TANNER
Active ingredients Purpose
Avobenzone3% Sunscreen
Homosalate 15% Sunscreen
Octisalate 5% Sunscreen
Octocrylene 8% Sunscreen
_USES_
• 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 • retains SPF after 80 minutes
activity in the water, sweating or perspiring • provides high
protection against sunburn
KEEP OUT OF REACH OF CHILDREN If product is swallowed, get medical
help or contact a Poison
Control Center right away.
STOP USE AND ASK A DOCTOR IF: rash or irritation develop and lasts
_WARNINGS_
• DO NOT USE: on damaged or broken skin
• WHEN USING THIS PRODUCT: keep out of eyes. Rinse with
water to remove.
FOR EXTERNAL USE ONLY
_DIRECTIONS_
• apply liberally 15 minutes before sun exposure
and at least every 2 hours. • children under 6 months of age:
ask a doctor. • 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 your time in the sun, especially from 10 a.m. – 2 p.m..
• wear long-sleeved shirts, pants, hats, and sunglasses
• reapply: (bullet) after 80 minutes of swimming or sweating
• immediately after towel drying
• at lease every 2 hours
For an all-over perfect tan, hold 6-8 inches from skin and spray
with a quick, continuous side-to-side motion. Apply liberally 15
minutes before sun exposure. Hold 6-8 inches from skin and
spray with a quick, continuous side-to-side motion. When
applying to face, spray onto hands and