Label: OIL OF BEAUTY- octinoxate, zinc oxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 55301-091-30 - Packager: Your Military Exchange
- 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 20, 2012
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
- Warnings
- Do not use
- When using
- Stop use and ask a doctor
- Keep out of reach of children
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Directions
Directions
- apply liberally 15 minutes before sun exposure
- reapply at least every 2 hours
- use a water resistant sunscreen if swimming or sweating
- Sun Protection Measures. Spending time in the sun increases your rish of skin cancer and early skin aging. To decrease this risk, regularly ue 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
- children under 6 months of age: ask a doctor
- Other information
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Inactive ingredients
Inactive Ingredientswater, glycerin, isohexadecane, polysorbate 80, sodium acrylate/acryloyldimethyl taurate copolymer, laureth-7, cyclopentasiloxane, PEG/PPG-20/20 dimethicone, steareth-21, stearyl alcohol, gossypium herbaceum (cotton) seed oil, behenyl alcohol, tocopheryl acetate, cetyl alcohol, DMDM hydantoin, iodopropynyl butylcarbamate, steareth-2, disodium EDTA, aloe barbadensis leaf extract, oleth-3 phosphate
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Claims on side panel
Complete Beauty Lotion give your sking a complete balance of moisturizing ingredient for healthy skin,
UVA/UVB Protection - Broad spectrum UVA and UVB protection with SPF 15 to help prevent premature sking damage.
Vitamins - this formula with antioxidant vitamin E plus aloe helps promote and maintaind healthy-looking skin.
Result - glowing, beautiful healthy skin.
- Disclaimer
- Adverse Reactions
- Prncipal display panel
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
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INGREDIENTS AND APPEARANCE
OIL OF BEAUTY
octinoxate, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55301-091 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) octinoxate 60 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 30 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) ISOHEXADECANE (UNII: 918X1OUF1E) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX) LAURETH-7 (UNII: Z95S6G8201) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) PEG/PPG-20/20 DIMETHICONE (UNII: BA94B7CK8K) STEARETH-21 (UNII: 53J3F32P58) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) LEVANT COTTONSEED OIL (UNII: N5CFT140R8) DOCOSANOL (UNII: 9G1OE216XY) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CETYL ALCOHOL (UNII: 936JST6JCN) DMDM HYDANTOIN (UNII: BYR0546TOW) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) STEARETH-2 (UNII: V56DFE46J5) EDETATE DISODIUM (UNII: 7FLD91C86K) ALOE VERA LEAF (UNII: ZY81Z83H0X) OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55301-091-30 1 in 1 CARTON 1 177 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 10/22/2007 Labeler - Your Military Exchange (001695568) Registrant - Vi-Jon (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon 088520668 manufacture(55301-091)
