Label: SUN ,BUG HANDSFREE 01- avobenzone,homosalate,octocrylene,octisalate cream
- NDC Code(s): 82953-010-01, 82953-010-02, 82953-010-03, 82953-010-04
- Packager: Cosmuses Cosmetics (Ningbo) Co., Ltd.
- 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 April 9, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
- Uses
- Warnings
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
-
Directions
- apply liberally 15minutes before sun exposure
- reapply:
- after 80 minutes of swimming or sweating
- immediate after towel drying
- at least every 2 hours
- Sun Protection Measures
Spending time increases your risk of skin cancer and early skin aging. To decreases 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:Ask a doctor
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
SUN ,BUG HANDSFREE 01
avobenzone,homosalate,octocrylene,octisalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82953-010 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 10 g in 100 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 10 g in 100 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL Inactive Ingredients Ingredient Name Strength PEPPERMINT OIL (UNII: AV092KU4JH) CITRONELLA OIL (UNII: QYO8Q067D0) EAST INDIAN LEMONGRASS OIL (UNII: UP0M8M3VZW) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) PHENOXYETHANOL (UNII: HIE492ZZ3T) YELLOW WAX (UNII: 2ZA36H0S2V) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETETH-25 (UNII: 5KLY4IOG20) METHYLPARABEN (UNII: A2I8C7HI9T) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) PROPYLPARABEN (UNII: Z8IX2SC1OH) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82953-010-01 10 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/26/2022 2 NDC:82953-010-02 15 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/26/2022 3 NDC:82953-010-03 30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/26/2022 4 NDC:82953-010-04 60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/26/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 09/26/2022 Labeler - Cosmuses Cosmetics (Ningbo) Co., Ltd. (725290934) Registrant - Cosmuses Cosmetics (Ningbo) Co., Ltd. (725290934) Establishment Name Address ID/FEI Business Operations Cosmuses Cosmetics (Ningbo) Co., Ltd. 725290934 manufacture(82953-010)
