REEF REPAIR SPF 30 SUNCREAM- zinc oxide, 20% cream

Reef Repair SPF 30 by

Drug Labeling and Warnings

Reef Repair SPF 30 by is a Otc medication manufactured, distributed, or labeled by Alive 2 Dive Company Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient

Zinc Oxide, 20%

PURPOSE

Purpose

Sunscreen

INDICATIONS & USAGE

Uses

• Helps prevent sunburn
• Helps protect the skin against the harmful effects of UVA, UVA II, and UVB rays
• Retains SPF for up to 80 minutes of activity in water or when sweating
• Moisturizing

WARNINGS

Warnings

• For external use only
• Do not use on damaged or broken skin
• Avoid contact with the eyes. If contact occurs rinse with clean water
• Stop use and ask a doctor if rash or irritation develops

DOSAGE & ADMINISTRATION

Directions

• Apply liberally and evenly to dry skin 15 minutes before sun exposure
• Apply to all exposed areas
• Re-apply at least every 2 hours, or immediately after swimming, perspiring, towel drying or vigorous activiy
• Children under 6 months of age: Ask you doctor
• Sun exposure increases your risk of skin cancer and early skin aging. To decrease this risk, use a sunscreen with a Broad Spectrum SPF value of 15 or higher

INACTIVE INGREDIENT

Inactive ingredients

Aqua, Cocos nuciera (Coconut oil), Persea gratissma (Avocado oil), Cetearyl alcohol / Polysorbate 60 (Vegatable emulsifying wax NF), Butyrospernum parkii (Shea butter), Rubus idaeus (Red Raspberry seed oil), Glyceryl Oleate Citrate & Caprylic / Capric Triglyceride, Glycerin, Cera alba (Beeswax), Ethylhexylglycerin & Propanediol, Polyhydoxystearic acid, Sodium Gluconate, Cocos nucifera (Coconut essential oil), Vanilla plantifolia (Vanilla essential oil)

OTHER SAFETY INFORMATION

Other Information

• 100% biodegradable non-toxic, reef safe formula
• Contains no harmful chemicals, parabens or silicones
• Broad Spectrum SPF 30+
• PA+++
• Cruetly free (Not tested on animals)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

REEF REPAIR SPF 30  SUNCREAM
zinc oxide, 20% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73541-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	20 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM GLUCONATE (UNII: R6Q3791S76)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYSORBATE 60 (UNII: CAL22UVI4M)
SHEA BUTTER (UNII: K49155WL9Y)
RASPBERRY SEED OIL (UNII: 9S8867952A)
GLYCERYL MONOOLEATE CITRATE (UNII: NLE5KIG74K)
GLYCERIN (UNII: PDC6A3C0OX)
PROPANEDIOL (UNII: 5965N8W85T)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
VANILLA PLANIFOLIA OIL (UNII: 0A3F415158)
WHITE WAX (UNII: 7G1J5DA97F)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
COCONUT OIL (UNII: Q9L0O73W7L)
AVOCADO OIL (UNII: 6VNO72PFC1)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73541-001-01	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/27/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	12/27/2019

Labeler - Alive 2 Dive Company Limited (662332223)

Establishment
Name	Address	ID/FEI	Business Operations
Alive 2 Dive Company Limited		662332223	manufacture(73541-001)