THE GOOD STUFF AFTERSHAVE SPF 15- avobenzone, octocrylene, and octisalate cream

The Good Stuff by

Drug Labeling and Warnings

The Good Stuff by is a Otc medication manufactured, distributed, or labeled by Prime Enterprises Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Avobenzone 2%

Octisalate 5%

Octocrylene 1.85%

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 on damaged or broken skin

When using this product keep out of eyes.

Rinse with water to remove.

Stop use and ask a doctor if rash occurs.

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply liberally 15 minutes before sun exposure
• reapply:
• after 40 minutes of swimming or sweating
• immediately after towel drying
• at least every 2 hours
• 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 spectrum SPF 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
• children under 6 months: Ask a doctor

Inactive Ingredients

Water, Glycerin, C12-15 Alkyl Lactate, Dimethicone, Disodium Lauriminodipropionate Tocopheryl Phosphates, Diisopropyl Adipate, Steareth-2, Aluminum Starch Octenylsuccinate, Octyldodecyl Stearate, Steareth-21, Fragrance, Acrylamide/Sodium Acrylate Copolymer, Mineral Oil, Aloe Barbadensis Leaf Juice, Phenoxyethanol, Trideceth-6, Disodium EDTA, Methylisothiazolinone

Other Information

• protect this product from excessive heat and direct sun

Questions or comments?

• Call toll free 954-525-9209

The Good Stuff After Shave SPF15

INGREDIENTS AND APPEARANCE

THE GOOD STUFF  AFTERSHAVE SPF 15
avobenzone, octocrylene, and octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58443-0198
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	20 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	18.5 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
DISODIUM LAURIMINODIPROPIONATE TOCOPHERYL PHOSPHATES (UNII: 0K5Y9U1P6M)
GLYCERIN (UNII: PDC6A3C0OX)
MINERAL OIL (UNII: T5L8T28FGP)
STEARETH-2 (UNII: V56DFE46J5)
STEARETH-21 (UNII: 53J3F32P58)
OCTYLDODECYL STEARATE (UNII: K6F16QGO28)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIDECETH-6 (UNII: 3T5PCR2H0C)
C12-15 ALKYL LACTATE (UNII: GC844VRD7E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM ACRYLOYLDIMETHYLTAURATE-ACRYLAMIDE COPOLYMER (1:1; 90000-150000 MPA.S) (UNII: 5F4963KLHS)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58443-0198-3	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/08/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	10/08/2015

Labeler - Prime Enterprises Inc. (101946028)

Registrant - Prime Enterprises Inc. (101946028)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises Inc.		101946028	pack(58443-0198) , manufacture(58443-0198) , label(58443-0198)