SPF 30 Sunscreen description, usages, side effects, indications, overdosage, supplying and lots more!

SPF 30 Sunscreen

Innovation Specialties

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Drug Facts



FULL PRESCRIBING INFORMATION

Active ingredient

Active Ingredients

Octinoxate 7.5 %

Oxybenzone 4.0 %

Octisalate 2.0 %

Titanium Dioxide 2.5%

Purpose

Purpose

Sunscreen

Keep out of reach of children, If swallowed get medical help or contact  a Poison Control Center.

Uses

Directions

  • Non-Water Resistant Product.
  • Apply liberally 15 minutes before sun exposure.
  • Reapply at least every 2 hours.
  • Children under 6 months : Ask a doctor

Warnings:

This product has been shown only to prevent sunburn NOT skin cancer or early skin aging.

For external use only. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Dosage and Administration

  • Apply liberally 15 minutes before sun exposure.
  • Reapply at least every 2 hours.
  • Children under 6 months : Ask a doctor

Inactive Ingredients

C12-15 Alkyl Benzoate, Ceteareth-25, Cetearyl Alcohol, Disodium EDTA, Glycerin, Glyceryl

Stearate, Myristyl Propionate, PEG-15 Cocomonium Chloride, PEG-9 Dimethicone,

Propylene Glycol Dioleate, Water, Xanthan Gum.

SPF 30 Sunscreen

Octinoxate, Oxybenzone, Octisalate, Titanium Dioxide LOTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:76138-204
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 7.5 mg
OXYBENZONE OXYBENZONE 4 mg
OCTISALATE OCTISALATE 2 mg
titanium dioxide 2.5 mg

Inactive Ingredients

Ingredient Name Strength
ALKYL (C12-15) BENZOATE
CETEARETH-25
CETOSTEARYL ALCOHOL
EDETATE DISODIUM
GLYCERIN
GLYCERYL MONOSTEARATE
MYRISTYL PROPIONATE
SODIUM LAURYL SULFATE
PEG-9 DIMETHICONE
PROPYLENE GLYCOL DIOLEATE
water
XANTHAN GUM

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:76138-204-03 30 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2013-06-05


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