BROAD SPECTRUM SPF 50 CAREONE- avobenzone 3% homosalate 13% octisalate 5% octocrylene 7% oxybenzone 4% lotion

Broad Spectrum SPF 50 by

Drug Labeling and Warnings

Broad Spectrum SPF 50 by is a Otc medication manufactured, distributed, or labeled by Careone, Product Quest Mfg, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

3% Avobenzone

13% Homosalate

5% Octisalate

7% Octocrylene

4% Oxybenzone

Purpose

Sunscreen

Uses

• helps prevent sunburns

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

Keep out of reach of children.

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

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 aging. 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, especially from 10 a.m. - 2 p.m.
• wear long-sleeve shirts, pants, hats, and sunglasses
• children under 6 months: Ask a doctor

Inactive Ingredients

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

Other Information

• protect this product from excessive heat and direct sun
• may stain fabrics

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BROAD SPECTRUM SPF 50  CAREONE
avobenzone 3% homosalate 13% octisalate 5% octocrylene 7% oxybenzone 4% lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41520-736
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 HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (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)
TROLAMINE (UNII: 9O3K93S3TK)
EICOSYL POVIDONE (UNII: XQQ9MKE2BJ)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41520-736-06	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/25/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/25/2018

Labeler - Careone (809183973)

Registrant - Product Quest Mfg, LLC (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg, LLC		927768135	manufacture(41520-736) , label(41520-736)