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NDC 51239-1921-00 Scrubs Sunscreen .07; .35; .525; .35; .42 g/g; g/g; g/g; g/g; g/g Details

Scrubs Sunscreen .07; .35; .525; .35; .42 g/g; g/g; g/g; g/g; g/g

Scrubs Sunscreen is a CUTANEOUS LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by ITW Pro Brands. The primary component is AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE.

Product Information

NDC	51239-1921
Product ID	51239-1921_d24263cc-d418-61fb-e053-2995a90a4e22
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Scrubs Sunscreen
Proprietary Name Suffix	n/a
Non-Proprietary Name	Sunscreen
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	CUTANEOUS
Active Ingredient Strength	.07; .35; .525; .35; .42
Active Ingredient Units	g/g; g/g; g/g; g/g; g/g
Substance Name	AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE
Labeler Name	ITW Pro Brands
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part352
Listing Certified Through	n/a

Package

Package Images

NDC 51239-1921-00 (51239192100)

Pricing Information	N/A
NDC Package Code	51239-1921-0
Billing NDC	51239192100
Package	7 g in 1 POUCH (51239-1921-0)
Marketing Start Date	2017-05-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 7b6b75a5-d433-5a5c-e053-2a91aa0a4d8d Details

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

INGREDIENTS AND APPEARANCE

SCRUBS SUNSCREEN

sunscreen lotion

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)
TROLAMINE (UNII: 9O3K93S3TK)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:51239-1921-0	7 g in 1 POUCH; Type 0: Not a Combination Product	05/01/2017	09/08/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	05/01/2017	09/08/2023

Labeler - ITW Pro Brands (067952994)

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

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

Revised: 12/2021

Document Id: d24263cc-d418-61fb-e053-2995a90a4e22

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

Version: 7

Effective Time: 20211203