Country: United States
Language: English
Source: NLM (National Library of Medicine)
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51), OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)
Tekweld Solutions, Inc.
TOPICAL
OTC DRUG
Purpose: Octinoxate ..............................Sunscreen Oxybenzone ...........................Sunscreen Uses: - Helps prevent sunburn • Do not use on broken skin • Stop use and ask doctor : if rash or irritation develops and persists.
OTC monograph final
CB 102- SPF 15 LIP BALM LIPSTICK TEKWELD SOLUTIONS, 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._ ---------- SPF 15 _DRUG FACTS_ _ACTIVE INGREDIENTS:_ Octinoxate 7.5% Oxybenzone 3.0% _PURPOSE:_ Octinoxate ..............................Sunscreen Oxybenzone ...........................Sunscreen US ES : Helps prevent sunburn _WARNINGS_ • 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 only to help prevent sunburn, NOT skin cancer or early skin aging. • FOR EXTERNAL USE ONLY. • DO NOT USE on broken skin • WHEN USING THIS PRODUCT keep out of eyes. Rinse with water to remove. • STOP USE AND ASK DOCTOR: if rash or irritation develops and persists. • KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center right away. _DIRECTIONS_ • Apply liberally 15 minutes before sun exposure as needed • CHILDREN UNDER 6 MONTHS OF AGE: ask a doctor before use. • Reapply at least every 2 hours. • Use a water resistant sunscreen if swimming or sweating. _INACTIVE INGREDIENTS_ Petrolatum, Paraffin, Mineral Oil, Theobroma Cacao (Cocoa) Seed Butter, Zea Mays (Corn) Oil, Glycine Soja (Soybean) Oil, Tocopherol, Simmondisa Chinensis (Jojoba) Seed Oil, Copernicia Cerifera (Carnauba) Wax, Retinyl Palmitate, Aloe Barbadensis Leaf Extract, BHA, Propyl Gallate, Citric Acid, Cholecalciferol. _OTHER INFORMATION_ • Protect this product from excessive heat and direct sun QUESTIONS OR COMMENTS? WWW.TEKWELD.COM MADE IN USA PRODUCT PACKAGE _SPF15_ NATURAL • ALOE VERA • SAFETY SEALED PEEL BACK FOR DRUG FACTS NET WT. 0.15 OZ (4.25G) DISTRIBUTED BY: TEKWELD 45 RABRO DR. HAUPPAUGE, NY 11788 res CB 102 spf 15 lip balm lipstick PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:7116 0 -19 2 ROUTE OF ADMINISTRATION TOPIC Read the complete document