FRESH SKIN ORGANICS- ab nat zinc lotion

Fresh Skin Organics by

Drug Labeling and Warnings

Fresh Skin Organics by is a Otc medication manufactured, distributed, or labeled by Tropical Enterprises International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients:

Zinc Oxide (18%)

PURPOSE

Purpose: Sunscreen

INDICATIONS & USAGE

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

WARNINGS:

For external use only.

Do not use on damaged or broken skin.

WHEN USING

When using this product avoid contact with eyes.

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

STOP USE

Stop use and ask a doctor if irritation or rash develops

and persists.

KEEP OUT OF REACH OF CHILDREN

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

Questions? Call 1-800-535-5053

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FRESH SKIN ORGANICS 
ab nat zinc lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58418-425
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	6.05 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	white (zinc lotion)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58418-425-00	15 mL in 1 PACKET; Type 0: Not a Combination Product	03/02/2020
2	NDC: 58418-425-05	15 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	03/02/2020
3	NDC: 58418-425-01	30 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	03/02/2020
4	NDC: 58418-425-02	60 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	03/02/2020
5	NDC: 58418-425-04	120 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	03/02/2020
6	NDC: 58418-425-08	240 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	03/02/2020
7	NDC: 58418-425-09	240 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/02/2020
8	NDC: 58418-425-16	480 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/02/2020
9	NDC: 58418-425-12	360 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/02/2020
10	NDC: 58418-425-64	1920 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/02/2020
11	NDC: 58418-425-34	100.55 mL in 1 TUBE; Type 0: Not a Combination Product	03/01/2020
12	NDC: 58418-425-28	3840 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/02/2020
13	NDC: 58418-425-55	211200 mL in 1 DRUM; Type 0: Not a Combination Product	03/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/01/2020

Labeler - Tropical Enterprises International, Inc. (091986179)

Registrant - Tropical Enterprises International, Inc. (091986179)

Establishment
Name	Address	ID/FEI	Business Operations
Tropical Enterprises International, Inc.		091986179	repack(58418-425)