SUNBAR SPF 30- avobenzone octinoxate oxybenzone titanium dioxide lotion

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX), OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51), OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y), TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)

Available from:

Kamins Dermatologics Inc.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

This oil and fragrance-free broad spectrum UVA/UVB sunscreen provides important protection against the sun’s harmful rays. Recommended for use on face and body, for everyday wear and outdoor activities. This cosmetically elegant formula is non-greasy, leaves a matte finish, and can be reapplied over makeup. • fragrance-free • oil-free • for face and body 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 30 - AVOBENZONE OCTINOXATE OXYBENZONE TITANIUM DIOXIDE
LOTION
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 SPF30 CONSUMER LABELING
Active ingredients:
Avobenzone 2.5%
Octinoxate 7.5%
Oxybenzone 6%
Titanium dioxide 2%
Purpose: Sunscreen
Keep out of children’s reach.
This oil and fragrance-free broad spectrum UVA/UVB sunscreen provides
important protection against
the sun’s harmful rays. Recommended for use on face and body, for
everyday wear and outdoor
activities. This cosmetically elegant formula is non-greasy, leaves a
matte finish, and can be reapplied
over makeup.
• fragrance-free • oil-free
• for face and body
Uses
■ Helps prevent sunburn.
■ Higher SPF gives more sunburn protection.
■ Provides high protection against sunburn.
Warnings
For external use only.
When using this product, keep out of eyes. If contact occurs, rinse
abundantly with water to remove.
Stop use and ask a doctor if rash or irritation develops and lasts.
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.
■ Reapply every two hours or as needed.
■ Reapply after swimming, towel drying, washing or perspiring
heavily.
■ Children under 6 months of age: ask a doctor.
Inactive ingredients: water, octyldodecyl neopentanoate, propylene
glycol, acer saccharum, tocopheryl
acetate, cetyl alcohol, stearic acid, DEA-cetyl phosphate, panthenol,
dimethicone, xanthan gum,
carbomer, sodium hydroxide, phenoxyethanol, chlorphenesin, BHT, iron
oxides (CI 7749