SABAL MINERAL SUNSCREEN BROAD SPRECTRUM SPF 30- zinc oxide lotion

SABAL Mineral Sunscreen Broad Sprectrum SPF 30 by

Drug Labeling and Warnings

SABAL Mineral Sunscreen Broad Sprectrum SPF 30 by is a Otc medication manufactured, distributed, or labeled by SABAL SUN LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Zinc Oxide 14%

Purpose

Sunscreen

Uses:

• Helps prevent sunburn.
• If used as directed with other sun protection measures see  Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings:

• For external use only.

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:

• 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:

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:

INGREDIENTS AND APPEARANCE

SABAL MINERAL SUNSCREEN BROAD SPRECTRUM SPF 30 
zinc oxide lotion

Product 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)