LIP BALM by J. A. Cosmetics U.S. INC / Shanghai J. A. Cosmetics Trading CO., LTD.

LIP BALM by

Drug Labeling and Warnings

LIP BALM by is a Otc medication manufactured, distributed, or labeled by J. A. Cosmetics U.S. INC, Shanghai J. A. Cosmetics Trading CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

LIP BALM SPF 15- octinoxate, oxybenzone lipstick 
J. A. Cosmetics U.S. INC

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.

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Active Ingredients:

​OCTINOXATE (7.5%)

OXYBENZONE (5%)

Purpose:

SUNSCREEN

Uses:

HELPS PREVENT SUNBURN

Warning:

For external use only

Skin Cancer/Skin Aging Alert

  • Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown to help preven sunburn, not skin cancer or skin aging.

When Using This Product

  • KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE.

Stop use and ask a doctor if

  • rash or irritation develops.

KEEP OUT OF REACH OF CHILDREN.

  • IF SWALLOWED GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

Directions:

  • APPLY LIBERALLY AS OFTEN AS NEEDED BEFORE SUN EXPOSURE.
  • REAPPLY AS NEEDED OR AFTER SWIMMING OR TOWEL DRYING.

Sun Protection Measures:

Spending time in the sun increases your risk of 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 10 a.m. - 2 p.m.
  • Wear long-sleeved shirt, pants, hats and sunglasses
  • Children under 6 months of age: Ask doctor.

OTHER INFORMATION

  • Protect the product in this container from excessive heat and direct sun.
  • Store at room temperature 20°C - 25°C (68°F-77°F)

Inactive Ingredient:

polybutene, paraffinum liquidum (mineral oil), paraffin, microcrystalline wax (cera microcristallina), cersin, caprylic/capric triglyceride, polyethylene, bis-diglyceryl polyacryladipate-2, butyrospermum parkii (shea) butter, mentha piperita (peppermint)oil, polyglyceryl-4 isostearate, tocopheryl acetate (VE), phenoxyethanol, methylparaben, ethylparaben, butylparaben, isobutylparaben, propylparaben

May Contain: MICA, TITANUM DIOXIDE (CI 77891), IRON OXIDES (CI 77491, CI 77492, CI 77499), YELLOW 6 LAKE (CI 15985), RED 27 LAKE (CI 45410), RED 6 LAKE (CI 15850), RED 40 LAKE (CI 16035)

82601-06 LipSPF15 0321.ai

82601-06 LipSPF15 logo 0321.ai

LIP BALM  SPF 15
octinoxate, oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 76354-110
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)  
MINERAL OIL (UNII: T5L8T28FGP)  
PARAFFIN (UNII: I9O0E3H2ZE)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
CERESIN (UNII: Q1LS2UJO3A)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
ADIPIC ACID (UNII: 76A0JE0FKJ)  
SHEA BUTTER (UNII: K49155WL9Y)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
ETHYLPARABEN (UNII: 14255EXE39)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
MICA (UNII: V8A1AW0880)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 6 BARIUM LAKE (UNII: K4XZD9W99K)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 76354-110-511 in 1 BOX06/10/201412/05/2019
1NDC: 76354-110-412.1 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35206/10/201412/05/2019
Labeler - J. A. Cosmetics U.S. INC (186705047)

Revised: 6/2014
 
J. A. Cosmetics U.S. INC