SPF-15 SUNSCREEN- octocrylene, avobenzone lotion

SPF-15 Sunscreen by

Drug Labeling and Warnings

SPF-15 Sunscreen by is a Otc medication manufactured, distributed, or labeled by Continental Manufacturing Chemist, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

 Octocrylene 10%

Avobenzone 3%

Uses

 Helps Prevent Sunburn

Purpose

 Helps prevent sunburn

Warnings

FOR EXTERNAL USE ONLY

Do not use

 in eyes, if this happens rinse thoroughly with water.

Stop use and ask a doctor if

 if skin irritation develops

Keep out of reach of children

 If swallowed, get medical help or contact a Poison Control Center

Ask a doctor

 before using on children under 6 months

Directions

 Apply liberally 15 minutes before sun exposure

Use a water resistant sunscreen if swimming or sweating

Reaaply at least every 2 hours

Storage

 Store at 20-25C (68-77F)

Inactive ingredients

 Aloe Barbadensis (Aloe Vera) Gel, Benzyl Alcohol, Carbopol, Cetyl Alcohol, Fragrance, (Glyceryl Stearate and PEG 100 Stearate), Methyl Paraben, PEG-40 Stearate, Phenoxyethanol, (Polyacrylamide and C13-14 Isoparrafin and Laureth-7), Propyl Paraben, Purified Water, Shea Butter, Sodium Hydroxide, Sorbitan Monooleate, Stearic Acid, Tetrasodium Ethylenediaminetatraacetate, Vitamin E

Principal Display Panel

 Product

SPF-15 Labels

 Labels

Manufactured By

 Continental Manufacturing Chemist, Inc.

912 S. State Street, Madrid, IA  50156

INGREDIENTS AND APPEARANCE

SPF-15 SUNSCREEN 
octocrylene, avobenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49794-048
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100.000 g  in 1.0 L
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30.000 g  in 1.0 L

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
METHYLPARABEN (UNII: A2I8C7HI9T)
PEG-40 STEARATE (UNII: ECU18C66Q7)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM ACRYLOYLDIMETHYLTAURATE-ACRYLAMIDE COPOLYMER (1:1; 90000-150000 MPA.S) (UNII: 5F4963KLHS)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SHEA BUTTER (UNII: K49155WL9Y)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
STEARIC ACID (UNII: 4ELV7Z65AP)
EDETATE SODIUM (UNII: MP1J8420LU)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49794-048-99	1100 L in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	05/16/2012

Labeler - Continental Manufacturing Chemist, Inc. (005278007)