SKIN STRONG - SKIN EQUIPMENT SPF 55 SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene, oxybenzone stick

SKIN STRONG - SKIN EQUIPMENT by

Drug Labeling and Warnings

SKIN STRONG - SKIN EQUIPMENT by is a Otc medication manufactured, distributed, or labeled by True Balance Athletics LLC, Dhaliwal Labs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

AVOBENZONE 3.00%, HOMOSALATE 15.00%, OCTISALATE 5.00%, OCTOCRYLENE 10.00%, OXYBENZONE 6.00%

PURPOSE

SUNSCREEN

USES

• HELPS PREVENT SUNBURN
• HIGHER SPF GIVES MORE SUNBURN PROTECTION

WARNINGS:

FOR EXTERNAL USE ONLY

WHEN USING

WHEN USING THIS PRODUCT:

• KEEP OUT OF THE EYES
• RINSE WITH WATER TO REMOVE

STOP USE

STOP USE AND ASK A DOCTOR IF RASH OR IRRITATION DEVELOPS OR LASTS

DIRECTIONS

• APPLY LIBERALLY 20 MINUTES BEFORE SUN EXPOSURE AND AS NEEDED
• FOR CHILDREN UNDER 6 MONTHS OF AGE, ASK A DOCTOR

SUN ALERT

Limiting sun exposure, wearing protective clothing and using sunscreen reduces the risk of skin aging, skin cancer and other harmful effects of the sun.

INACTIVE INGREDIENTS

BEESWAX, LAURYL LAURATE, OZOKERITE, CETEARYL BEHENATE, POLYBUTENE, CETYL ALCOHOL, STYRENE/ACRYLATES COPOLYMER, MYRISTYL MYRISTATE, TOCOPHEROL, COCOA SEED BUTTER, PHENOXYETHANOL, RETINYL PALMITATE, TETRAHEXYDECYL ASCORBATE

IMAGE OF LABEL

SPF55StickLabel.jpg

INGREDIENTS AND APPEARANCE

SKIN STRONG - SKIN EQUIPMENT  SPF 55 SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene, oxybenzone stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51401-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	150 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	60 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
YELLOW WAX (UNII: 2ZA36H0S2V)
LAURYL LAURATE (UNII: GPW77G0937)
CERESIN (UNII: Q1LS2UJO3A)
CETEARYL BEHENATE (UNII: 7ARI9LTH0U)
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)
CETYL ALCOHOL (UNII: 936JST6JCN)
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)
TOCOPHEROL (UNII: R0ZB2556P8)
COCOA BUTTER (UNII: 512OYT1CRR)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51401-002-01	13.3 g in 1 APPLICATOR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	08/30/2012

Labeler - True Balance Athletics LLC (011072321)

Registrant - Dhaliwal Labs (016754201)

Establishment
Name	Address	ID/FEI	Business Operations
Dhaliwal Labs		016754201	manufacture(51401-002)