BROAD SPECTRUM SPF 50 MINERAL SUNSCREEN- titanium dioxide, zinc oxide cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP), ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)

Available from:

Aruba Aloe Balm NV

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

- helps prevent sunburn - 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

Authorization status:

OTC monograph not final

Summary of Product characteristics

BROAD SPECTRUM SPF 50 MINERAL SUNSCREEN- TITANIUM DIOXIDE, ZINC
OXIDE CREAM
ARUBA ALOE BALM NV
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BROAD SPECTRUM SPF 50+ MINERAL SUNSCREEN
_DRUG FACTS_
_ACTIVE INGREDIENTS_
Titanium Dioxide 10% Zinc Oxide 10%
_PURPOSE_
Sunscreen
_USES_
helps prevent sunburn
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
_WARNINGS_
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 swallowed, get medical help or contact a Poison Control Center
right away.
_DIRECTIONS_
apply generously 15 minutes before sun exposure
reapply
after 80 minutes of swimming or sweating
immediately after towel drying
at least every 2 hours
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 andd other sun protection measures
including:
limit time in the sun, especially from 10 a.m.-2 p.m.
wear long-sleeved shirts, pants, hats, and sunglasses
children under 6 months of age: Ask a doctor
_OTHER INFORMATION_
protect the product in this container from excessive heat and direct
sun
_INACTIVE INGREDIENTS_
Water (Aqua/Eau), Helianthus Annuus (Sunflower) Seed Oil, Propanediol,
Aloe
Barbadensis Leaf Juice (Aloe Vera Gel from Aruba), Acetylated
Hydrogenated Vegetable
Glyceride, Polyglyceryl-3 Polyricinoleate, Fragrance (Parfum),
Caprylic/Capric Triglyceride,
Phenoxyethanol, Caprylyl Glycol, Chlorphenesin, Polyhydroxystearic
Acid, Stearic Acid,
Alumina, Acrylates/C10-30 Alkyl Acrylate Crosspolymer,
Acrylates/Beheneth-25
Methacrylate Copolymer, Tocopheryl (Vitamin E) Acetate, Sodium
Hydroxide.
PACKAGE LABELING:
BROAD SPECTRUM SPF 50 MINERAL SUNSCREEN
titanium dioxide, zinc oxide cream
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:53675-1