TENACIOUS ERGODYNE- spf 50 sunscreen lotion lotion

Tenacious by

Drug Labeling and Warnings

Tenacious by is a Otc medication manufactured, distributed, or labeled by Tenacious Holdings, Inc., FRUIT OF THE EARTH, INC., Fruit of the Earth Research Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone 3.0%, Homosalate 10.0%, Octocrylene 6.0%

Purpose

Sunscreen

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

water, cetearyl alcohol, stearyl alcohol, glycerin, acrylates/C12-22 alkyl methacrylate crosspolymer, cetyl alcohol, carbomer, ceteth-10 phosphate, dicetyl phosphate, coco-glucoside, xanthan gum, disodium EDTA, methyl dihydroabietate, lauryl PEG-8 dimethicone, phenylisopropyl dimethicone, polyglyceryl-3 stearate/isostearate/dimer dilinoleate crosspolymer, sodium ascorbyl phosphate, tocopheryl acetate, aloe barbadensis leaf juice, phenoxyethanol, triethanolamine, propylene glycol, hydroxyacetophenone.

QUESTIONS

Toll-Free 800 225 8238

Int'l +1 651 642 9889

PRINCIPAL DISPLAY PANEL

Tenacious Ergodyne KREWD SPF 50 Lotion

8 FL OZ (237mL)

NDC: 73620-001-11

Tenacious Ergodyne KREWD SPF 50 Lotion

1.5 FL OZ (44mL)

NDC: 73620-001-49

Tenacious Ergodyne KREWD SPF 50 Lotion

32 FL OZ (946mL)

NDC: 73620-001-72

INGREDIENTS AND APPEARANCE

TENACIOUS  ERGODYNE
spf 50 sunscreen lotion lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73620-001
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 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	60 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER (UNII: 7K68DGG29P)
CETYL ALCOHOL (UNII: 936JST6JCN)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
COCO GLUCOSIDE (UNII: ICS790225B)
XANTHAN GUM (UNII: TTV12P4NEE)
EDETATE DISODIUM (UNII: 7FLD91C86K)
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TROLAMINE (UNII: 9O3K93S3TK)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73620-001-11	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/13/2020
2	NDC: 73620-001-49	44 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/13/2020
3	NDC: 73620-001-72	946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	02/13/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/13/2020

Labeler - Tenacious Holdings, Inc. (108665142)

Registrant - FRUIT OF THE EARTH, INC. (079559467)

Establishment
Name	Address	ID/FEI	Business Operations
Fruit of the Earth Research Laboratories, Inc.		008193513	manufacture(73620-001)