Label: BROAD SPECTRUM SPF 15 CITRUS LIP BALM stick
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Contains inactivated NDC Code(s)
NDC Code(s): 65692-0548-1 - 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 December 23, 2020
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Warnings
- Do not use
- Stop Use and ask a doctor if
- When Using this Product
- Keep out of reach of children
- Directions
- Inactive ingredients:
- Package Label
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INGREDIENTS AND APPEARANCE
BROAD SPECTRUM SPF 15 CITRUS LIP BALM
broad spectrum spf 15 citrus lip balm stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65692-0548 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 0.21 g in 4.25 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 0.09 g in 4.25 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 0.06 g in 4.25 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.28 g in 4.25 g Inactive Ingredients Ingredient Name Strength COCONUT OIL (UNII: Q9L0O73W7L) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) WHITE PETROLATUM (UNII: B6E5W8RQJ4) CERESIN (UNII: Q1LS2UJO3A) MINERAL OIL (UNII: T5L8T28FGP) PARAFFIN (UNII: I9O0E3H2ZE) Product Characteristics Color Score Shape Size Flavor CITRUS Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65692-0548-1 4.25 g in 1 TUBE; Type 0: Not a Combination Product 02/17/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 02/17/2020 Labeler - Raining Rose, Inc (083819404)