Label: LYPSYL VANILLA PLUM INTENSE PROTECTION- lip balm lipstick
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Contains inactivated NDC Code(s)
NDC Code(s): 62721-8127-6, 62721-8127-8 - Packager: Lornamead
- 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 December 13, 2013
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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Active Ingredients
Octyl Methoxycinnamate 5.5%...................................Sunscreen
Octylcrylene 2.0%....................................................Sunscreen
Oxybenzone 3.5%....................................................Sunscreen
Avobenzone 3.0%.....................................................Sunscreen
- Inactive Ingredients
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Directions
- apply liberally 15 minutes before sun exposure
- after 40 minutes of swimming or sweating
- at least every 2 hours
- children under 6 months: ask a doctor
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 Broad Spectrum SPF vlaue of 15 or higher and other sun protection measures including
- limit time in the sun, especially from 10a.m. -2 p.m.
- wear long-sleeved shirts, pants hats and sunglasses
- Other Information
- Use
- Warnings
- Keep out of reach of children
- Questions or Comments
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LYPSYL VANILLA PLUM INTENSE PROTECTION
lip balm lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62721-8127 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 5.5 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 2.0 g in 100 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3.0 g in 100 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 3.5 g in 100 g Inactive Ingredients Ingredient Name Strength VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) ALPHA-TOCOPHEROL (UNII: H4N855PNZ1) YELLOW WAX (UNII: 2ZA36H0S2V) MINERAL OIL (UNII: T5L8T28FGP) PETROLATUM (UNII: 4T6H12BN9U) SHEA BUTTER (UNII: K49155WL9Y) CERESIN (UNII: Q1LS2UJO3A) PARAFFIN (UNII: I9O0E3H2ZE) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM) ACAI (UNII: 46AM2VJ0AW) Product Characteristics Color Score Shape Size Flavor PLUM (Vanilla Plum) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62721-8127-8 2.83 in 1 BLISTER PACK 1 NDC:62721-8127-6 2.83 g in 1 CANISTER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/01/2014 Labeler - Lornamead (126440440) Registrant - Lornamead (126440440) Establishment Name Address ID/FEI Business Operations CSR Cosmetic Solutions 243501959 manufacture(62721-8127) , pack(62721-8127)
