TENACIOUS ERGODYNE- krewd spf 50 sunscreen stick stick

Tenacious by

Drug Labeling and Warnings

Tenacious by is a Otc medication manufactured, distributed, or labeled by Tenacious Holdings, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone 3.0%, Homosalate 15.0%, Octisalate 5.0%, Octocrylene 10.0%

Purpose

Sunscreen

INDICATIONS & USAGE

Uses  helps prevent sunburn  if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only

DO NOT USE

Do not use  on damaged or broken skin.

WHEN USING

When using this product  keep out of eyes. Rinse with water to remove.

ASK DOCTOR

Stop use and ask a doctor if  rash occurs.

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.

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

• children under 6 months of age: Ask a doctor
• 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 sun, especially from 10 a.m.-2 p.m.

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

Other information

• protect the product in this container from excessive heat and direct sun
• may stain or damage some fabrics, materials or surfaces

Inactive ingredients

beeswax (apis mellifera), ozokerite, cetearyl behenate, lauryl lactate, polybutene, butyloctyl salicylate, cetyl alcohol, styrene/acrylates copolymer, myristyl myristate, theobroma cacao (cocoa) seed butter, phenoxyethanol, tetrahexyldecyl ascorbate (vitamin C ester), tocopherol (natural vitamin E).

QUESTIONS

TOLL-FREE 800 225 8238 // INT'L +1 651 642 9889

PRINCIPAL DISPLAY PANEL

Tenacious Ergodyne KREWD SPF 50 Sunscreen Stick

1.5 OZ (42g)

NDC: 73620-003-28

INGREDIENTS AND APPEARANCE

TENACIOUS  ERGODYNE
krewd spf 50 sunscreen stick stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73620-003
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

Inactive Ingredients
Ingredient Name	Strength
ROYAL JELLY (UNII: L497I37F0C)
LAURYL LACTATE (UNII: G5SU0BFK7O)
CERESIN (UNII: Q1LS2UJO3A)
CETEARYL BEHENATE (UNII: 7ARI9LTH0U)
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)
CETYL ALCOHOL (UNII: 936JST6JCN)
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)
COCOA BUTTER (UNII: 512OYT1CRR)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73620-003-28	42 g in 1 CONTAINER; Type 0: Not a Combination Product	02/14/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/14/2020

Labeler - Tenacious Holdings, Inc. (108665142)

Registrant - Fruit of the Earth, Inc. (008193515)

Establishment
Name	Address	ID/FEI	Business Operations
Fruit of the Earth, Inc.		079559467	manufacture(73620-003)