Label: BIG ISLAND BASICS- avobenzone, octinoxate, octisalate, octocrylene stick
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Contains inactivated NDC Code(s)
NDC Code(s): 65692-1005-1 - Packager: Raining Rose, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 April 10, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
Warnings
For external use only • Do not use on damaged or broken skin.
Stop use and ask a doctor if rash occurs. When using this
product keep out of eyes. Rinse with water to remove.
Keep out of reach of children. If swallowed get medical help
or contact Poison Control Center right away. For children
under 6 months of age ask a doctor before use. -
DOSAGE & ADMINISTRATION
Directions
•Apply liberally 15 minutes before sun exposure
• Reapply at least every 2 hours
• Use a water resistant sunscreen if swimming or sweatingSun Protection Measures. Spending time in the sun increases
your risk of skin cancer and early skin aging. To decrease this risk,
regularly use a sunscreen with a Broad-Spectrum SPF value of 15 or
higher and other sun protection measures including: limit time in the
sun, especially from 10 a.m. - 2 p.m. wear long-sleeved shirts, pants,
hats, and sunglasses - INACTIVE INGREDIENT
- OTHER SAFETY INFORMATION
- Principal Display Package
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INGREDIENTS AND APPEARANCE
BIG ISLAND BASICS
avobenzone, octinoxate, octisalate, octocrylene stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65692-1005 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 20 mg in 1 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 65 mg in 1 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 15 mg in 1 g Inactive Ingredients Ingredient Name Strength SUNFLOWER OIL (UNII: 3W1JG795YI) YELLOW WAX (UNII: 2ZA36H0S2V) OLIVE OIL (UNII: 6UYK2W1W1E) TOCOPHEROL (UNII: R0ZB2556P8) CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S) ROSEMARY (UNII: IJ67X351P9) ALOE VERA LEAF (UNII: ZY81Z83H0X) SOYBEAN OIL (UNII: 241ATL177A) SUNFLOWER OIL MONOGLYCERIDES (UNII: ZVW8EIZ3IE) CANOLA OIL (UNII: 331KBJ17RK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65692-1005-1 17 g in 1 TUBE; Type 0: Not a Combination Product 04/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 04/01/2020 Labeler - Raining Rose, Inc. (083819404) Registrant - Raining Rose, Inc. (083819404)
