Label: ALL GOOD BROAD SPECTRUM SPF 15 SPEARMINT LIP BALM- broad spectrum spf 15 spearmint lip balm stick
- NDC Code(s): 65692-0313-1
- Packager: Raining Rose, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 3, 2023
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
Risk Information • For external use only • Do not use on damaged or broken skin • If rash occurs, discontinue use and consult a health care practitioner • When using this product keep out of eyes. • Rinse with water to remove.
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, skin cancer or early skin aging.
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions • Apply liberally/generously (and evenly) 15 minutes before sun exposure. • Reapply: • at least every 2 hours • after 80 minutes of swimming or sweating • immediately after towel drying • after eating or drinking • For use on children less than 6 months of age, consult a health care practitioner. 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 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 shirts, pants, hats, and sunglasses • Use a water resistant sunscreen if swimming or sweating.
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INACTIVE INGREDIENT
Non-medicinal Ingredients: Organic Olea Europaea (Extra Virgin Olive) Fruit Oil, Cera Alba (Beeswax), Organic Calendula Officinalis (Calendula) Flower, Organic Symphytum Officinale (Comfrey) Leaf, Organic Plantago Lanceolata (Plantain) Leaf, Organic Lavandula Angustifolia (Lavender) Flower, Organic Achillea Millefolium (Yarrow) Flower, Organic Mentha Spicata (Spearmint Essential Oil), Non-GMO Tocopherol (Vitamin E). - Product Package Labeling
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INGREDIENTS AND APPEARANCE
ALL GOOD BROAD SPECTRUM SPF 15 SPEARMINT LIP BALM
broad spectrum spf 15 spearmint lip balm stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65692-0313 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 35 mg in 1 g Inactive Ingredients Ingredient Name Strength CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) COMFREY LEAF (UNII: DG4F8T839X) LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M) PLANTAGO MAJOR LEAF (UNII: 7DC28K241X) ACHILLEA MILLEFOLIUM FLOWER (UNII: YQR8R0SQEA) OLIVE OIL (UNII: 6UYK2W1W1E) YELLOW WAX (UNII: 2ZA36H0S2V) SPEARMINT OIL (UNII: C3M81465G5) TOCOPHEROL (UNII: R0ZB2556P8) Product Characteristics Color Score Shape Size Flavor SPEARMINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65692-0313-1 4.25 g in 1 TUBE; Type 0: Not a Combination Product 07/24/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 07/24/2023 Labeler - Raining Rose, Inc. (083819404)
