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

Skin Crave spf30 sunscreen by

Drug Labeling and Warnings

Skin Crave spf30 sunscreen by is a Otc medication manufactured, distributed, or labeled by Tropical Enterprises International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOSAGE & ADMINISTRATION

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 INGREDIENT

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

INDICATIONS & USAGE

Uses: Helps prevent sunburn.

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.

PURPOSE

Purpose:

Sunscreen

ACTIVE INGREDIENT

Active Ingredients:

Octocrylene 7%, Octinoxate 6.5%

Oxybenone 5.5 %, Octisalate 4%

WARNINGS

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/01/2012

Labeler - Tropical Enterprises International, Inc. (091986179)

Registrant - Tropical Enterprises International, Inc. (091986179)