BROAD SPECTRUM SPF 50 BABY SUNSCREEN PREFERRED PLUS PHARMACY- avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

Broad Spectrum SPF 50 Baby Sunscreen by

Drug Labeling and Warnings

Broad Spectrum SPF 50 Baby Sunscreen by is a Otc medication manufactured, distributed, or labeled by Kinray Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients

Avobenzone 3.0%, Homosalate 13.0%, Octisalate 5.0%, Octocrylene 7.0%, Oxybenzone 4.0%

INDICATIONS & USAGE

Uses

Helps prevent sunburn.

WARNINGS

Warnings

For external use only.  Do not use on damaged or broken skin. When using this product keep out of eyes.  Rinse with water to remove. Stop use and ask a doctor if rash occurs.

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

Inactive ingredients

Aluminum Starch Octenylsuccinate, Benzyl Alcohol, Carbomer, Dimethicone, Disodium EDTA, Fragrance, Methylparaben, Polyglceryl-3 Distearate, Propylparaben, Sorbitan Isostearate, Sorbitol, Stearic Acid, Tocopherol, Triethanolamine, VP/Eicosene Copolymer, Water.

PURPOSE

Purpose

Sunscreen.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

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

PRINCIPAL DISPLAY PANEL

Preferred Plus Pharmacy

Broad Spectrum SPF 50

Baby Sunscreen Lotion

Water Resistant (80 Minutes)

INGREDIENTS AND APPEARANCE

BROAD SPECTRUM SPF 50 BABY SUNSCREEN  PREFERRED PLUS PHARMACY
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61715-027
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	13 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	7 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CARBOMER 940 (UNII: 4Q93RCW27E)
DIMETHICONE (UNII: 92RU3N3Y1O)
EDETATE DISODIUM (UNII: 7FLD91C86K)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
SORBITOL (UNII: 506T60A25R)
STEARIC ACID (UNII: 4ELV7Z65AP)
TOCOPHEROL (UNII: R0ZB2556P8)
TRIETHANOLAMINE BENZOATE (UNII: M3EN4GC19W)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61715-027-08	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)