Label: BIORLX LIP BALM COLLAGEN- avobenzone, mineral oil, octinoxate, petrolatum, zinc oxide stick
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Contains inactivated NDC Code(s)
NDC Code(s): 80554-002-01, 80554-002-02 - Packager: LOTUSA LLC.
- 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 September 18, 2020
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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SPL UNCLASSIFIED SECTION
This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.
The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:
a. Avobenzone 1.0%w/w
b. Mineral Oil 30.0%w/w
c. Octinoxate 6.0% w/w
d. Petrolatum 30.0% w/w
e. Zinc Oxide 6.0% w/w
f. Aloe Barbadensis (Alove Vera) Leaf Juice
g. Beeswax
h. Butyrpsoermum (Shea) Parkii Butter
i.Caprylic/ Capric Triglyceride
j. Ceresin
k.Collagen
l. Microcrystalline Wax
m. Potassium Sorbate
n. Tocopherol
The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.
- Active Ingredient(s)
- Purpose
- Use
- Warnings
- Do not use
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WHEN USING
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. - STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
BIORLX LIP BALM COLLAGEN
avobenzone, mineral oil, octinoxate, petrolatum, zinc oxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80554-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1 g in 100 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 6 g in 100 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 6 g in 100 g PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 30 g in 100 g MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL 30 g in 100 g Inactive Ingredients Ingredient Name Strength WHITE WAX (UNII: 7G1J5DA97F) ALOE VERA LEAF (UNII: ZY81Z83H0X) TOCOPHEROL (UNII: R0ZB2556P8) BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU) COLLAGEN ALPHA-1(I) CHAIN BOVINE (UNII: FB3DQM32F2) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) CERESIN (UNII: Q1LS2UJO3A) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80554-002-02 12 in 1 BOX 09/01/2020 1 NDC:80554-002-01 3.5 g in 1 APPLICATOR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 03/30/2020 Labeler - LOTUSA LLC. (122415153) Registrant - LOTUSA LLC. (122415153) Establishment Name Address ID/FEI Business Operations FRENCH MALIHOME PERSONAL PRODUCTS LIMITED 664283791 manufacture(80554-002)
