Label: SABAL MINERAL SUNSCREEN BROAD SPRECTRUM SPF 30- zinc oxide lotion
- NDC Code(s): 84446-505-00
- Packager: SABAL SUN LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated June 25, 2024
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- Drug Facts
- Active Ingredient
- Uses:
- Warnings:
-
Directions:
- Apply liberally 15 minutes before sun exposure and as needed.
- Children under 6 months of age: ask a doctor.
- Reapply at least every two hours, after 80 minutes of swimming or sweating, or immediately after towel drying.
Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including:
- Limit time in the sun, especially from 10am - 2pm.
- Wear long sleeve shirts, pants, hats, and sunglasses.
- Other Information:
-
Inactive Ingredients:
Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, Calendula Officinalis Extract, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Caprylyl Glycol, Chamomilla Recutita (Chamomile) Extract, Citric Acid, Cocos Nucifera (Coconut) Oil, Decyl Glucoside, Ethyl Vanillin, Glycerin, Glyceryl Laurate, Glyceryl Stearate, Glyceryl Undecylenate, Helianthus Annuus (Sunflower) Oil, Hippophae Rhamnoides (Sea Buckthorn) Oil, Hydrogenated Methyl Abietate, Hydroxyethylcellulose, Lavandula Angustifolia (Lavender) Oil, Polyhydroxystearic Acid, Punica Granatum (Pomegranate) Extract, Spirea Ulmaria (Meadowsweet) Extract, Stearic Acid, Xanthan Gum, Zemea (Corn) Propanediol.
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- Package Labeling:
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INGREDIENTS AND APPEARANCE
SABAL MINERAL SUNSCREEN BROAD SPRECTRUM SPF 30
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:84446-505 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 140 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) WATER (UNII: 059QF0KO0R) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) SHEA BUTTER (UNII: K49155WL9Y) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) GREEN TEA LEAF (UNII: W2ZU1RY8B0) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CHAMOMILE (UNII: FGL3685T2X) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) COCONUT OIL (UNII: Q9L0O73W7L) DECYL GLUCOSIDE (UNII: Z17H97EA6Y) ETHYL VANILLIN (UNII: YC9ST449YJ) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL LAURATE (UNII: Y98611C087) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP) HYDROGENATED METHYL ABIETATE (UNII: A23O709X8O) HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D) LAVENDER OIL (UNII: ZBP1YXW0H8) PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D) STEARIC ACID (UNII: 4ELV7Z65AP) XANTHAN GUM (UNII: TTV12P4NEE) CORN (UNII: 0N8672707O) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:84446-505-00 89 mL in 1 TUBE; Type 0: Not a Combination Product 06/11/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 06/11/2024 Labeler - SABAL SUN LLC (119212492)
