Spf30 Sunscreen lotion (non broad spectrum)

Directions: Apply liberally and evenly 15 minutes before sun exposure.

Reapply every 2 hours as needed, after 40 minutes of swimming or sweating, or immedaitely after towel dry9ing.

For use on children under 6 months: consult a physician

Inactive Ingredients: Acrylic Polymer, Diazolidinyl Urea, Disodium EDTA, Hypromellose, Methylparaben, Propylene Glycol, Propylparaben, PPG-15 Stearyl Ether Benzoate, Triethanolamine, Water

Uses: Helps prevent sunburn.

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

Purpose:

Sunscreen

Active Ingredients:

Octocrylene 7%, Octinoxate 6.5%

Oxybenone 5.5 %, Octisalate 4%

WARNINGS: Skin Cancer/ Sking Aging Alert: Spending time in the sun

increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer and early skin aging.

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 or persists.

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

PLPDN

SKIN CRAVE SPF30 SUNSCREEN
spf30 sunscreen lotion (non-broad spectrum) lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58418-223
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	4 mg in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	5.5 mg in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	7 mg in 1 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	6.5 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
MAGNESIUM DISODIUM EDTA (UNII: NDT563S5VZ)
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
PPG-15 STEARYL ETHER BENZOATE (UNII: 80D2J6361M)
CUPRIC TRIETHANOLAMINE (UNII: 6NU949U74E)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58418-223-10	10 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	08/01/2012
2	NDC:58418-223-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/01/2012
3	NDC:58418-223-02	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/01/2012
4	NDC:58418-223-04	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/01/2012
5	NDC:58418-223-08	240 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/01/2012
6	NDC:58418-223-80	240 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/01/2012
7	NDC:58418-223-12	360 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/01/2012
8	NDC:58418-223-16	480 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/01/2012
9	NDC:58418-223-64	1920 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/01/2012
10	NDC:58418-223-28	3840 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/01/2012

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	08/01/2012

Labeler - Tropical Enterprises International, Inc. (091986179)

Registrant - Tropical Enterprises International, Inc. (091986179)