Label: THE BETTER OIL- homosalate, octocrylene, avobenzone oil
- NDC Code(s): 82975-102-02
- Packager: frank body
- 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 31, 2022
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients
- Purpose
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Uses
• Helps prevent sunburn• If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
- Warnings
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Directions
Apply generously and evenly 15 minutes before sun exposure•Reapply: After 80 minutes of swimming or sweating.•Immediately after towel drying.•At least every 2 hours
•Sun 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 10a.m.-2p.m.
- Wear long sleeve shirts, pants, hats and sunglasses
- Children under 6 months of age: Ask a doctor
- Inactive ingredients
- Other information
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
THE BETTER OIL
homosalate, octocrylene, avobenzone oilProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82975-102 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 80 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 100 mg in 1 mL Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STANNIC OXIDE (UNII: KM7N50LOS6) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) MINERAL OIL (UNII: T5L8T28FGP) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q) ALMOND OIL (UNII: 66YXD4DKO9) MICA (UNII: V8A1AW0880) COCOA BUTTER (UNII: 512OYT1CRR) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) COCONUT OIL (UNII: Q9L0O73W7L) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) JOJOBA BUTTER (UNII: XIA46H803R) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82975-102-02 100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/31/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 12/31/2022 Labeler - frank body (747810740)
