SUNBAR SPF 48- ensulizole homosalate octinoxate octocrylene zinc oxide cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42), HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S), OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51), OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM), ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)

Available from:

Kamins Dermatologics Inc.

INN (International Name):

ENSULIZOLE

Composition:

ENSULIZOLE 30 mg in 1 mL

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

A hydrating, broad spectrum UVA/UVB sunscreen, which provides protection against sunburn. Combines our moisturizing Bio-MapleTM compound with a mixture of sunscreens that protect skin by scattering, reflecting and absorbing harmful sun rays. Fragrance, color and oil-free, ideal for those with sensitive skin. Uses ■ Helps prevent sunburn. ■ Higher SPF gives more sunburn protection. ■ Provides high protection against sunburn.

Authorization status:

OTC monograph final

Summary of Product characteristics

SUNBAR SPF 48 - ENSULIZOLE HOMOSALATE OCTINOXATE OCTOCRYLENE ZINC
OXIDE CREAM
KAMINS DERMATOLOGICS 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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SUNBAR SPF48 CONSUMER LABELING
Active ingredients:
Ensulizole 3%
Homosalate 10%
Octinoxate 7.5%
Octocrylene 7%
Zinc oxide 8%
Purpose: Sunscreen
Keep out of children’s reach.
A hydrating, broad spectrum UVA/UVB sunscreen, which provides
protection against sunburn.
Combines our moisturizing Bio-Maple
compound with a mixture of sunscreens that protect skin by
scattering, reflecting and absorbing harmful sun rays. Fragrance,
color and oil-free, ideal for those with
sensitive skin.
Uses
■ Helps prevent sunburn.
■ Higher SPF gives more sunburn protection.
■ Provides high protection against sunburn.
Warnings
For external use only.
Avoid contact with eyes when using this product. If contact occurs,
rinse abundantly with water to
remove.
Discontinue use in case of excessive skin irritation or if condition
does not improve. If irritation
persists, consult a health care practitioner.
If swallowed, seek medical assistance or contact a Poison Control
Center immediately.
Other information
Sun alert: Limiting sun exposure, wearing protective clothing, and
using sunscreens may reduce the
risks of skin aging, skin cancer, and other harmful effects of the
sun.
Store at room temperature 15-30°C (59-86°F).
Directions
■ Apply liberally and evenly to face and exposed areas 15-30 minutes
before sun exposure.
TM
■ Reapply every two hours or as needed.
■ Reapply after swimming, towel drying, washing or perspiring
heavily.
■ Consult a doctor before using on children under six months of age.
Inactive ingredients: water, cyclopentasiloxane, dimethiconol, acer
saccharum (maple isolate), glycerin,
cyclohexasiloxane, cetearyl alcohol, steareth-100, polyacrylamide,
C13-14 isoparaffin, laureth-7,
steareth-2, di