Scrubs Sunscreen by ITW Pro Brands / Pure Source, LLC / Lico Industries SCRUBS Sunscreen Lotion

Scrubs Sunscreen by

Drug Labeling and Warnings

Scrubs Sunscreen by is a Otc medication manufactured, distributed, or labeled by ITW Pro Brands, Pure Source, LLC, Lico Industries. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SCRUBS SUNSCREEN- sunscreen lotion 
ITW Pro Brands

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.

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SCRUBS Sunscreen Lotion

ACTIVE INGREDIENTS

Purpose

0.070g Avobenzone 1.0%..........Sunscreen
0.350g Homosalate 5.0%...........Sunscreen
0.525g Octinoxate 7.5%.............Sunscreen
0.350g Octisalate 5.0%..............Sunscreen
0.420g Oxybenzone 6.0%..........Sunscreen

USAGE

-Helps prevent sunburn

-If used as directed with other sun measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

WARNING

For external use only

Do not use on damaged or broken skin.

When using the product, keep out of eyes, rinse with water to remove.

DIRECTIONS

Directions

-apply liberally (or generously) and evenly 15 minutes before sun exposure.

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 Value of 15 or higher and other sun protection measures including:

-limit time in the sum, especially from 10 a.m. – 2 p.m.

-wear long-sleeved shirts, pants, hats, and sunglasses

reapply:

-after 80 minutes of swimming or sweating.

-immmediatly after towel drying.

-at least every 2 hours.

Children under 6 months of age: Ask a doctor.

INACTIVE INGREDIENTS

Acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis (aloe vera) leaf juice, butylparaben, carbomer, calendula officinalis flower extract, chamomile recutita (matricaria) extract, C12-15 alkyl benzoate, dimethicone, dimethyl capramide, ethylparaben, fragrance (parfum), glyceryl stearate, isobutylparaben, methylparaben, nasturtium officinale (watercress) extract, peg-100 stearate, phenoxyethanol, propylparaben, symphytum officinale (comfrey) leaf extract, tetrasodium EDTA, tocopherol, tocopheryl acetate, triethanolamine, water.

STORAGE AND HANDLING

Protect this product from excessive heat and sun.

ASK A DOCTOR

Stop use and ask a doctor if a rash occurs.

KEEP OUT OF THE REACH OF CHILDREN

Keep out of the reach of children

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

PURPOSE

Sunscreen

PACKAGE LABEL

SCRUBS SUNSCREEN 
sunscreen lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51239-1921
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.35 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.42 g  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	0.35 g  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.525 g  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.07 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
TROLAMINE (UNII: 9O3K93S3TK)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
EDETATE SODIUM (UNII: MP1J8420LU)
WATER (UNII: 059QF0KO0R)
SYMPHYTUM OFFICINALE WHOLE (UNII: H8FJJ6KX5Y)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
DIMETHICONE 200 (UNII: RGS4T2AS00)
PEG-100 STEARATE (UNII: YD01N1999R)
TOCOPHEROL (UNII: R0ZB2556P8)
C12-20 ALKYL BENZOATE (UNII: Y15I6XI14C)
ETHYLPARABEN (UNII: 14255EXE39)
METHYLPARABEN (UNII: A2I8C7HI9T)
WATERCRESS (UNII: K5877MW0LE)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
CHAMOMILE (UNII: FGL3685T2X)
DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51239-1921-0	7 g in 1 POUCH; Type 0: Not a Combination Product	05/01/2017	05/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	05/01/2017	05/01/2017

Labeler - ITW Pro Brands (067952994)

Establishment
Name	Address	ID/FEI	Business Operations
Pure Source, LLC		080354456	manufacture(51239-1921) , analysis(51239-1921)

Establishment
Name	Address	ID/FEI	Business Operations
Lico Industries		098009041	pack(51239-1921) , label(51239-1921)

Revised: 10/2019

Document Id: 95981385-4d0f-e7a5-e053-2a95a90ab598

34390-5

Set id: 7b6b75a5-d433-5a5c-e053-2a91aa0a4d8d

Version: 3

Effective Time: 20191023

 

ITW Pro Brands