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


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts sheet



Drug Facts

Active Ingredients                           Purpose

Octinoxate, titanium dioxide          sunscreens

Use
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.
For skin highly sensitive to sunburn.

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 6 months of age: ask a doctor.
Apply liberally 20 minutes before sun exposure and as needed.

Inactive ingredients: water (aqua), C12-15 alkyl benzoate, glycerin, glyceryl stearate, PEG-100 stearate, cetearyl alcohol, alumina, panthenol, tocopheryl acetate, VP/eicosene copolymer, helianthus annuus, (sunflower) seed oil, ITT/TCS crosspolymer, polyhydroxystearic acid, fragrance (parfum), phenoxyethanol, acetamide MEA, lactic acid, dimethicone, methylparaben, magnesium aluminum silicate, potassium sorbate, sodium dehydroacetate, butylene glycol, disodium EDTA, xanthan gum, caprylic/capric triglyceride, alcohol, cassia alata leaf extract, ethylparaben, butylparaben, propylparaben, sodium carboxymethyl beteglucen, isobutylparaben, tocopherol, ascorbyl tetraisopalmitate, pantolactone, ascorbyl palmitate, carbomar, citric acid, ascorbic acid, DNA. 
 

Tube 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 over expose yourself to the sun, even if you are using a sunscreen.

Tube inactive ingredients listing



Active ingredients: octinoxate, titanium dioxide.
Inactive ingredients: water (aqua), C12-15 alkyl benzoate, glycerin, glyceryl stearate, PEG-100 stearate, cetearyl alcohol, alumina, panthenol, tocopheryl acetate, VP/eicosene copolymer, helianthus annuus, (sunflower) seed oil, ITT/TCS crosspolymer, polyhydroxystearic acid, fragrance (parfum), phenoxyethanol, acetamide MEA, lactic acid, dimethicone, methylparaben, magnesium aluminum silicate, potassium sorbate, sodium dehydroacetate, butylene glycol, disodium EDTA, xanthan gum, caprylic/capric triglyceride, alcohol, cassia alata leaf extract, ethylparaben, butylparaben, propylparaben, sodium carboxymethyl beteglucen, isobutylparaben, tocopherol, ascorbyl tetraisopalmitate, pantolactone, ascorbyl palmitate, carbomar, citric acid, ascorbic acid, DNA. 

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:44924-102
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
titanium dioxide 2.327 mL
OCTINOXATE OCTINOXATE 2.252 mL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:44924-102-01 30 in 1 TUBE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2010-06-01


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