High Protection Sun SPF 30 description, usages, side effects, indications, overdosage, supplying and lots more!

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High Protection Sun SPF 30

Babor Cosmetics America, Corp.

Drug Facts insert


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient



Drug Facts

Active Ingredients                           Purpose

Octinoxate, titanium dioxide          sunscreens

Uses
Sunscreen to help prevent sunburn.
Allows you to stay in the sun up to 30 times longer than without sunscreen protection.
Protects from the sun to help prevent skin damage.

Warnings
For external use only
Do not swallow, avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Allergy Alert
If contact occurs, rinse eyes thoroughly with water.

Stop use and ask doctor if irritation or rash persists.

Keep this out of reach of children.
In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately. Store at room temperature.

Directions
Adults and children 6 months of age and over: Apply liberally as often as necessary.
Children under 2 years of age should use sunscreen products with a minimum SPF of 4.
Children under 6 months of age: Consult a doctor.

Inactive Ingredients
water (aqua), C12 15 alkyl benzoate, glyceryl stearate, PEG 100 stearate, glycerin, alumina, panthenol, cetearyl alcohol, tocopheryl acetate, VP eicosene copolymer, helianthus annuus (sunflower) seed oil, sodium carboxymethyl betaglucan, cassia alata leaf extract, acetamide MEA, lactic acid, ascorbyl tetraisopalmitate, ascorbyl palmitate, tocopherol, ascorbic acid, DNA, butylene glycol, xanthan gum, caprylic capric triglyceride, pantolactone, ITT TCS crosspolymer, polyhydroxyethanol, methylparaben, ethylparaben, propylparaben, butylparaben, isobutylparaben, potassium sorbate, sodium dehydroacetate.
 

Carton label description



A moisturizing sun lotion for the face and body with a high sun protection factor.
Caution: Apply sunscreen liberally before sun exposure. Applying an insufficient amount of sunscreen will reduce the level of sun protection (i.e. the SPF) indicated. Avoid intensive midday sun. Reapply frequently in order to maintain protection, especially after perspiring, swimming or drying off with a towel. Shield babies and toddlers from direct UV radiation, dress them in protective clothing and use a sunscreen with a minimum SPF of 25. Do not overexpose yourself to the sun, even if you are using a sunscreen.

Carton label inactive ingredients



Inactive Ingredients
water (aqua), C12 15 alkyl benzoate, glyceryl stearate, PEG 100 stearate, glycerin, alumina, panthenol, cetearyl alcohol, tocopheryl acetate, VP eicosene copolymer, helianthus annuus (sunflower) seed oil, sodium carboxymethyl betaglucan, cassia alata leaf extract, acetamide MEA, lactic acid, ascorbyl tetraisopalmitate, ascorbyl palmitate, tocopherol, ascorbic acid, DNA, butylene glycol, xanthan gum, caprylic capric triglyceride, pantolactone, ITT TCS crosspolymer, polyhydroxyethanol, methylparaben, ethylparaben, propylparaben, butylparaben, isobutylparaben, potassium sorbate, sodium dehydroacetate.

High Protection Sun SPF 30

High Protection Sun SPF 30

Titanium Dioxide CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:44924-101
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
titanium dioxide 15.50 mL
OCTINOXATE OCTINOXATE 15 mL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:44924-101-01 200 in 1 TUBE
2 NDC:44924-101-02 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2010-03-01


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