FRESH SKIN ORGANICS- ab nat zinc lotion 
Tropical Enterprises International, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Formula: ABNZ2000

Active Ingredients:

Zinc Oxide (18%)

Purpose: Sunscreen

Uses: Our SPF formulas provide both UVA and UVB

protection, and are infused with antioxidants and nutrients to help

prevent sun damage while keepingthe skin well-hydrated.

WARNINGS:

For external use only.

Do not use on damaged or broken skin.

When using this product avoid contact with eyes.

If contact with eyes occurs, flush with water to remove.

Stop use and ask a doctor if irritation or rash develops

and persists.

Keep out of reach of children. If product is swallowed,

seek immediate medical attention or contact a Poison Control Center

right away.

For use on children under 6 months: consult a physician.

Questions? Call 1-800-535-5053

30ml

FRESH SKIN ORGANICS 
ab nat zinc lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58418-425
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE6.05 g  in 30 mL
Inactive Ingredients
Ingredient NameStrength
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
PROPANEDIOL (UNII: 5965N8W85T)  
CASTOR OIL (UNII: D5340Y2I9G)  
ROSEMARY OIL (UNII: 8LGU7VM393)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
KUKUI NUT OIL (UNII: TP11QR7B8R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
GLYCERIN (UNII: PDC6A3C0OX)  
SHEA BUTTER (UNII: K49155WL9Y)  
JOJOBA OIL (UNII: 724GKU717M)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
LAURIC ACID (UNII: 1160N9NU9U)  
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)  
AVOCADO OIL (UNII: 6VNO72PFC1)  
XANTHAN GUM (UNII: TTV12P4NEE)  
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)  
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
CAPRYLIC ACID (UNII: OBL58JN025)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
CAMELLIA SINENSIS WHOLE (UNII: C5M4585ZBZ)  
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
RASPBERRY SEED OIL (UNII: 9S8867952A)  
SQUALANE (UNII: GW89575KF9)  
Product Characteristics
Colorwhite (zinc lotion) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58418-425-0015 mL in 1 PACKET; Type 0: Not a Combination Product03/02/2020
2NDC:58418-425-0515 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product03/02/2020
3NDC:58418-425-0130 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product03/02/2020
4NDC:58418-425-0260 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product03/02/2020
5NDC:58418-425-04120 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product03/02/2020
6NDC:58418-425-08240 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product03/02/2020
7NDC:58418-425-09240 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/02/2020
8NDC:58418-425-16480 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/02/2020
9NDC:58418-425-12360 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/02/2020
10NDC:58418-425-641920 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/02/2020
11NDC:58418-425-34100.55 mL in 1 TUBE; Type 0: Not a Combination Product03/01/2020
12NDC:58418-425-283840 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/02/2020
13NDC:58418-425-55211200 mL in 1 DRUM; Type 0: Not a Combination Product03/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/01/2020
Labeler - Tropical Enterprises International, Inc. (091986179)
Registrant - Tropical Enterprises International, Inc. (091986179)
Establishment
NameAddressID/FEIBusiness Operations
Tropical Enterprises International, Inc.091986179repack(58418-425)

Revised: 3/2020
Document Id: a05edd7b-be70-0f10-e053-2995a90a2b6e
Set id: a05edd7b-be6f-0f10-e053-2995a90a2b6e
Version: 1
Effective Time: 20200308
 
Tropical Enterprises International, Inc.