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    NDC 63645-0165-01 Sunfrog Ultra SPF 30 Lip Balm 7.5; 5; 7; 5; 30 mg/g; mg/g; mg/g; mg/g; mg/g Details

    Sunfrog Ultra SPF 30 Lip Balm 7.5; 5; 7; 5; 30 mg/g; mg/g; mg/g; mg/g; mg/g

    Sunfrog Ultra SPF 30 Lip Balm is a TOPICAL STICK in the HUMAN OTC DRUG category. It is labeled and distributed by OraLabs. The primary component is OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE; PETROLATUM.

    Product Information

    NDC 63645-0165
    Product ID 63645-165_ec2f0978-7ec8-49a3-8954-5475cbb581a3
    Associated GPIs
    GCN Sequence Number n/a
    GCN Sequence Number Description n/a
    HIC3 n/a
    HIC3 Description n/a
    GCN n/a
    HICL Sequence Number n/a
    HICL Sequence Number Description n/a
    Brand/Generic n/a
    Proprietary Name Sunfrog Ultra SPF 30 Lip Balm
    Proprietary Name Suffix n/a
    Non-Proprietary Name Octinoxate, Octocrylene, Oxybenzone, Octisalate, Petroleum Jelly
    Product Type HUMAN OTC DRUG
    Dosage Form STICK
    Route TOPICAL
    Active Ingredient Strength 7.5; 5; 7; 5; 30
    Active Ingredient Units mg/g; mg/g; mg/g; mg/g; mg/g
    Substance Name OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE; PETROLATUM
    Labeler Name OraLabs
    Pharmaceutical Class n/a
    DEA Schedule n/a
    Marketing Category OTC MONOGRAPH NOT FINAL
    Application Number part352
    Listing Certified Through 2024-12-31

    Package

    NDC 63645-0165-01 (63645016501)

    NDC Package Code 63645-165-01
    Billing NDC 63645016501
    Package 1 g in 1 CONTAINER (63645-165-01)
    Marketing Start Date 2017-11-29
    NDC Exclude Flag N
    Pricing Information N/A
    << 63645-0164-01 63645-0166-01 >>

    Contents

    Standard Product Labeling (SPL)/Prescribing Information SPL 61299626-bf60-40e8-a2d3-4d4a99d8d15c Details

    Revised: 11/2022
    Document Id: ec2f0978-7ec8-49a3-8954-5475cbb581a3
    Set id: 61299626-bf60-40e8-a2d3-4d4a99d8d15c
    Version: 2
    Effective Time: 20221108