Moderate Protection Sun SPF 15 description, usages, side effects, indications, overdosage, supplying and lots more!

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Moderate Protection Sun SPF 15

Babor Cosmetics America, Corp

Drug Facts insert


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient



Drug Facts

Active Ingredients                      Purpose
octinoxate, octocrylene,            sunscreens             
avobenzone, sulisobenzone

Uses
Sunscreen to help prevent sunburn.
Allows you to stay in the sun up to 15 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, butylene glycol, cocoglycerides, dicaprylyl carbonate, polyglyceryl 5 laurate, tocopheryl acetate, phenoxyethanol, panthenol, glycerin, fragrance (parfum), acetamide MEA, sodium hydroxide, acrylates C10 30 alkyl acrylate crosspolymer, disodium EDTA, ethylhexylglycerin, potassium sorbate, cassia alata leaf extract, caprylic capric triglyceride, biosaccharide gum 4, biosaccharide gum 1, sodium carboxymethyl betaglucan, ascorbyl tetraisopalmitate, tocopherol, pantolactone, ethylparaben, methylparaben, propylparaben, carbomer, citric acid, DNA. 
 
 

Carton panel description



A oil free, water resistant spray lotion for skin that is sensitive to the sun and prone to sun allergies. Contains a moderate sun protection factor to protect the face and body from sunburn.
The innovative, anti aging formula, which is based on the BABOR SKIN PROTECTION COMPLEX (SPC+), increases the skin’s natural defenses before sun exposure, inhibits the formation and spread of free radicals during sun exposure and promotes sustained cell regeneration after sun exposure.
In combination with broad spectrum UVA and UVB filters, SPC+ thus effectively combats premature, light induced skin aging. 

Carton panel inactive ingredients




Inactive Ingredients

water (aqua), C12 15 alkyl benzoate, butylene glycol, cocoglycerides, dicaprylyl carbonate, polyglyceryl 5 laurate, tocopheryl acetate, phenoxyethanol, panthenol, glycerin, fragrance (parfum), acetamide MEA, sodium hydroxide, acrylates C10 30 alkyl acrylate crosspolymer, disodium EDTA, ethylhexylglycerin, potassium sorbate, cassia alata leaf extract, caprylic capric triglyceride, biosaccharide gum 4, biosaccharide gum 1, sodium carboxymethyl betaglucan, ascorbyl tetraisopalmitate, tocopherol, pantolactone, ethylparaben, methylparaben, propylparaben, carbomer, citric acid, DNA. 

Moderate Protection Sun SPF 15

Moderate Protection Sun SPF 15

Octocrylene SPRAY

Product Information

Product Type Human otc drug label Item Code (Source) NDC:44924-100
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTOCRYLENE Octocrylene 20 mL
OCTINOXATE OCTINOXATE 15 mL
AVOBENZONE AVOBENZONE 6 mL
SULISOBENZONE 4 mL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:44924-100-01 200 in 1 BOTTLE, SPRAY
2 NDC:44924-100-02 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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