SABAL MINERAL SUNSCREEN BROAD SPRECTRUM SPF 30- zinc oxide lotion 
SABAL SUN LLC

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SABAL Mineral Sunscreen Broad Sprectrum SPF-30

Drug Facts

Active Ingredient

Zinc Oxide 14%

Purpose

Sunscreen

Uses:

Warnings:

Do not use

  • on damaged or 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 lasts.

Keep out of reach of children.

  • If swallowed, get medical help or contact a Poison Control Center right away.

If pregnant or breastfeeding,

ask a health professional before use.

Directions:

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:

Other Information:

Protect the product in this container from excessive heat and direct sunlight.

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.

Questions?

Email: support@sabalsun.com

Call:(727)-209-7730

Package Labeling:

LABEL

SABAL MINERAL SUNSCREEN BROAD SPRECTRUM SPF 30 
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84446-505
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION140 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:84446-505-0089 mL in 1 TUBE; Type 0: Not a Combination Product06/11/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02006/11/2024
Labeler - SABAL SUN LLC (119212492)

Revised: 6/2024
Document Id: 1bb2bfb0-76f6-0abc-e063-6394a90a6745
Set id: f917b446-4e10-4231-826e-fdac32e11186
Version: 1
Effective Time: 20240625
 
SABAL SUN LLC