PROJECT REEF SPF-30 MINERAL SUNSCREEN- zinc oxide cream

PROJECT REEF SPF-30 Mineral Sunscreen by

Drug Labeling and Warnings

PROJECT REEF SPF-30 Mineral Sunscreen by is a Otc medication manufactured, distributed, or labeled by Project Reef LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Zinc Oxide 14.00%

Purpose

Sunscreen

Uses:

• Helps prevent sunburn
• higher SPF gives more sunburn protection
• retains SPF after 80 minutes of swimming or sweating
• If used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun. Directions

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 a 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 breast-feeding,

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:
• after 80 minutes of swimming or sweating
• immediately after towel drying 
• at least every 2 hours
• Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:: Sun Protection Measures.
• Limit time in the sun, especially from 10 a.m. - 2 p.m.
• Wear long- sleeved shirts, pants, hats, and sunglasses

Other Information:

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

Inactive Ingredients:

Algae Extract, *Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Benzyl Alcohol, *Butyrospermum Parkii (Shea) Butter, *Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Citric Acid, Citrus Aurantium Dulcis (Orange) Oil, *Cocos Nucifera (Coconut) Oil, Decyl Glucoside, Dehydroacetic Acid, Ethyl Vanillin, Fucus Vesiculosus (Seaweed) Extract, *Glycerin, Glyceryl Stearate, Helianthus Annuus, * Hippophae Rhamnoides (Sea Buckthorn) Oil, Hydroxyethylcellulose, Polyhydroxystearic Acid, *Punica Granatum (Pomegranate) Extract, Rubus Idaeus (Raspberry) Extract, Stearic Acid, Tridecyl Salicylate, Xanthan Gum, Zemea (Corn) Propanediol.

Questions?

Call 800 914 0146

Package Labeling:

INGREDIENTS AND APPEARANCE

PROJECT REEF SPF-30 MINERAL SUNSCREEN 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81637-139
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)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SHEA BUTTER (UNII: K49155WL9Y)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ORANGE OIL (UNII: AKN3KSD11B)
COCONUT OIL (UNII: Q9L0O73W7L)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
ETHYL VANILLIN (UNII: YC9ST449YJ)
NORI (UNII: 477TV3P5UX)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
HIPPOPHAE RHAMNOIDES SEED OIL (UNII: T53SBG6741)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
POMEGRANATE (UNII: 56687D1Z4D)
RUBUS IDAEUS SEED (UNII: M3CL7US2ZG)
STEARIC ACID (UNII: 4ELV7Z65AP)
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)
XANTHAN GUM (UNII: TTV12P4NEE)
CORN (UNII: 0N8672707O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81637-139-00	125 mL in 1 TUBE; Type 0: Not a Combination Product	03/08/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	03/08/2021

Labeler - Project Reef LLC (096500461)