Label: SKIN CRAVE SPF30 SUNSCREEN (spf30 sunscreen lotion- non-broad spectrum lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 58418-223-01, 58418-223-02, 58418-223-04, 58418-223-08, view more58418-223-10, 58418-223-12, 58418-223-16, 58418-223-28, 58418-223-64, 58418-223-80 - Packager: Tropical Enterprises International, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated December 1, 2014
If you are a consumer or patient please visit this version.
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- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- INDICATIONS & USAGE
- KEEP OUT OF REACH OF CHILDREN
- PURPOSE
- ACTIVE INGREDIENT
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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
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INGREDIENTS AND APPEARANCE
SKIN CRAVE SPF30 SUNSCREEN
spf30 sunscreen lotion (non-broad spectrum) lotionProduct 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)
