SUN TOTAL PROTECTOR COLOR 30 LIGHT TINT- zinc oxide, octisalate, octinoxate cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z), Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W), Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)

Available from:

MD Formulations

INN (International Name):

Zinc Oxide

Composition:

Zinc Oxide 7.8 mL in 100 mL

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Authorization status:

OTC monograph not final

Summary of Product characteristics

SUN TOTAL PROTECTOR COLOR 30 LIGHT TINT - ZINC OXIDE, OCTISALATE,
OCTINOXATE CREAM
MD FORMULATIONS
_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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TOTAL PROTECTOR COLOR 30 LIGHT TINT
Zinc Oxide - 7.8%
Octlnoxate - 7.5%
Octlsolote - 4.0%
Zinc Oxide - 7.8% Sunscreen
Octlnoxate - 7.5% Sunscreen
Octlsolote - 4.0% Sunscreen
When using this product do not use in or near the eyes. If product
gets into eyes, rinse thoroughly with
water.
Uses to help prevent sunburn and for the temporary protection of
sunburn.
WARNINGS : For external use only.
Stop use and ask a doctor if irritation or rash appears and lasts.
Keep out of reach of children. If swallowed, get medical help or
contact a Poison Control Center right
away.
Children under 2 years of age should use sunscreen products with a
minimum SPF of 4. Adults and
children 6 months and over; apply liberally 15 minutes before sun or
water exposure; reapply after
swimming or excessive sweating or anytime after towel drying. Children
under 6 months ask a doctor.
Other information Store at 20-25C (68 - 77F) SUN ALERT: The sun causes
sun damage. Regular use of
sunscreens over the years may reduce the chance of skin damage, some
types of skin cancer, and other
harmful effects due to the sun.
INACTIVE INGREDIENTS: Water (Aqua), C12-15 Alkyl Benzoate, Glyceryl
Stearate, Glycerin, Stearelh·2,
Stearelh-100, Trlcontanyl PVP, PEG-100 stearate, Tocopheryl Acetate,
Allantoin, Dimethicone,
Xanthan Gum, Cetyl Hydroxyethylcellulose, Disodium EDTA, Diazolidinyl
Urea, lodopropynl
Butylcarbamate, Methyldibromo Glutaronitrile, Phenoxyethanol,
Methylparaben, Propylparaben, MIca
(CI 77019), Blsmuth OxychlorIde (CI 77163), Iron Oxides (CI77489)
SUN TOTAL PROTECTOR COLOR 30 LIGHT TINT
zinc oxide, octisalate, octinoxate cream
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 6 0 78 -50 3
ROUTE OF ADMINISTRA