KIDS SUNSCREEN- octinoxate and titanium dioxide lotion

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Octyl Methoxycinnamate 7%, Titanium Dioxide 2.8%

Available from:

Kareway Product, Inc.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Sunscreen Sunscreen helps prevent sunburn

Authorization status:

OTC monograph not final

Summary of Product characteristics

KIDS SUNSCREEN- OCTINOXATE AND TITANIUM DIOXIDE LOTION
KAREWAY PRODUCT, 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._
----------
DRUG FACTS
ACTIVE INGREDIENTS
Octyl Methoxycinnamate 7%
Titanium Dioxide 2.8%
PURPOS E
Sunscreen
Sunscreen
US E
helps prevent sunburn
WARNINGS
SKIN CANCER/EARLY SKIN AGING ALERT: Spending time in the sun increases
your risk of skin cancer and
early skin aging. This product has been shown only to prevent sunburn,
NOT skin cancer or early skin
aging.
FOR EXTERNAL USE ONLY.
DO NOT USE
on damaged or broken skin
WHEN USING THIS PRODUCT
Keep out of eyes. Rinse with water to remove.
STOP USE AND ASK A DOCTOR
if rash occurs
KEEP OUT OF REACH OF CHILDREN.
If product is swallowed, get medical help or call a Poison Control
Center right away.
DIRECTIONS
apply liberally 15 minutes before sun exposure
reapply:
after 40 minutes of swimming or sweating
immediately after towel drying
at least every 2 hours
children under 6 months: Ask a doctor
OTHER INFORMATION
protect this product from excessive heat and direct sun
may stain fabrics
for Lot and Expiration Date, see crimp of tube
INACTIVE INGREDIENTS
Water, Glycerin, Glyceryl Stearate,
PEG-100 Stearate, Stearic acid, Cetearyl Alcohol, Phenoxyethanol,
Acrylates/C10-30 alkyl acrylate crosspolymer, Chlorphenesin,
Triethanolamine, Lavandula Angustifolia (Lavender) Extract,
Salvia Sclarea (Clary) Extract, Hyacinthus Orientalis Extract,
Chamomilla Recutita (Matricaria) Flower/Leaf Extract, Borago
officinalis Extract, Centaurea cyanus flower Extract, Dimethicone,
Butylene Glycol, 1,2-Hexanediol, Ethylhexylglycerin, Disodium
EDTA, Fragrance
PACKAGE LABEL
Pure Aid Kids Sunscreen Lotion
KIDS SUNSCREEN
octinoxate and titanium dioxide lotion
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 7510 -0 0 8 2
ROUTE OF ADMINISTRATION
TOPICAL
Kareway Product, Inc.
ACTIVE INGREDIENT/