Label: BROAD SPECTRUM SPF 30 SUNSCREEN PREFERRED PLUS PHARMACY- avobenzone, homosalate, octisalate, octocrylene lotion
-
Contains inactivated NDC Code(s)
NDC Code(s): 61715-025-08 - Packager: Kinray Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated March 15, 2013
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- WARNINGS
-
DOSAGE & ADMINISTRATION
Directions
Apply liberally 15 minutes before sun exposure. Reapply: after 80 minutes of swimming or sweating, immediately after towel drying, at least every 2 hours.
Sun Protection Measures: spending time in the sun increases your risk of skin cancer and early skin again. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, specially from 10am - 2pm, wear long-sleeve shirts, pants, hats, and sunglasses.
Children under 6 months: ask a doctor.
- INACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
BROAD SPECTRUM SPF 30 SUNSCREEN PREFERRED PLUS PHARMACY
avobenzone, homosalate, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61715-025 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 10 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 10 g in 100 mL Inactive Ingredients Ingredient Name Strength CARBOMER 1342 (UNII: 809Y72KV36) BENZYL ALCOHOL (UNII: LKG8494WBH) CHLORPHENESIN (UNII: I670DAL4SZ) DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248) EDETATE DISODIUM (UNII: 7FLD91C86K) ETHYLHEXYL PALMITATE (UNII: 2865993309) OLETH-3 (UNII: BQZ26235UC) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) TOCOPHEROL (UNII: R0ZB2556P8) TRIETHANOLAMINE BENZOATE (UNII: M3EN4GC19W) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61715-025-08 237 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/15/2013 Labeler - Kinray Inc. (012574513)
