OTC Medication Information: Sunspray

SUNSPRAY- avobenzone, homosalate, octinoxate, octisalate and titanium dioxide spray
Kiss My Face, 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.

Active ingredients

Avobenzone (3.0%), Homosalate (5.0%), Octinoxate (7.5%), Octisalate (6.5%), Titanium Dioxide (2.0%).

Inactive ingredients

Aloe Barbadensis Leaf Juice, Camellia Sinensis (Green Tea) Extract, Carthamus Tinctorius (Safflower) Oleosomes, Cetearyl Alcohol, Cetearyl Olivate, Citric Acid, Daucus Carota Sativa (Carrot) Extract, Dimethicone, Ethylhexylglycerin, Eucalyptus Globulus Oil, Glycerin, Helianthus Annuus (Sunflower) Oil, Lecithin, Phenoxyethanol, Polysorbate-20, Sorbitan Olivate, Styrene/Acrylates Copolymer, Water, Zemea Propanediol.

Keep out of reach of children

Keep out of reach of children.

Directions

Apply liberally 15 minutes before sun exposure

Do not spray directly on face

Reapply ater 80 minutes of swimming or sweating, immediately after towel drying, at least ever 2 hours

Children under 6 months ask a doctor

Use

Helps prevent sunburn

Purpose

sunscreen

Warnings

Do not use on damaged or broken skin

Stop use and ask doctor if rash occurs

When using this product keep out of eyes. Rinse with water to remove.

If swallowed get medical help or contact a poison control center right away

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SUNSPRAY
avobenzone, homosalate, octinoxate, octisalate, titanium dioxide spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:65364-218
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE (AVOBENZONE) AVOBENZONE 3 g in 100 g
HOMOSALATE (HOMOSALATE) HOMOSALATE 5 g in 100 g
OCTINOXATE (OCTINOXATE) OCTINOXATE 7.5 g in 100 g
OCTISALATE (OCTISALATE) OCTISALATE 6.5 g in 100 g
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 2 g in 100 g
Inactive Ingredients
Ingredient Name Strength
water
GREEN TEA LEAF
ALOE VERA LEAF
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES
CETOSTEARYL ALCOHOL
CETEARYL OLIVATE
CITRIC ACID ACETATE
DAUCUS CAROTA SUBSP. CAROTA WHOLE
DIMETHICONE
EUCALYPTUS GUNNII LEAF OIL
GLYCERIN
SUNFLOWER OIL
LECITHIN, SOYBEAN
PHENOXYETHANOL
POLYSORBATE 20
SORBITAN OLIVATE
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000)
PROPANEDIOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65364-218-01 100 g in 1 BOTTLE, SPRAY None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 01/01/2015
Labeler — Kiss My Face, LLC (041794279)
Registrant — Kiss My Face, LLC (041794279)

Revised: 01/2015 Kiss My Face, LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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