REEF REPAIR SUNSCREEN SPF 40- zinc oxide/titanium dioxide cream

Reef Repair Sunscreen SPF 40 by

Drug Labeling and Warnings

Reef Repair Sunscreen SPF 40 by is a Otc medication manufactured, distributed, or labeled by Alive 2 Dive Co Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Zinc oxide 20%

Titanium dioxide 2.5%

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

Do not use on damaged or broken skin

Stop use and ask a doctor

Stop use and ask a doctor if rash occurs

When using this product

when using this product keep out of eyes. Rinse with water to remove

Keep out of reach of children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Apply liberally and evenly 15 minutes before sun exposure
• Apply to all skin exposed to the sun
• Apply to dry skin
• 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
• Sun Protection Measures: Spending time in the sun increases your rish of skin cancer and early skin aging. To decrease this risk, regularly use a suncreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
• 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
• May stain some fabrics

Inactive ingredients

Helianthus annuus (Sunflower seed) oil

Caprylic/Capric Triglyceride

Coco Caprylate

Cera alba (Beeswax)

Isoamyl Laurate

Limonia Acidissim (Thanaka) powder

Polyglyceryl 3 Polyricinoleate

Tocopherol Acetate (Vitamin E)

Stearic acid

Alumina

QUESTIONS

• Natural reef safe formula
• Broad Spectrum SPF 40
• PA+++
• Moisturizing
• Water resistant (80 Minutes)
• Applies Clear
• Contains no harmful chemicals, parabens, dyes or silicones
• Cruelty free ( Not tested on animals)
• Kid Friendly

label

INGREDIENTS AND APPEARANCE

REEF REPAIR SUNSCREEN SPF 40 
zinc oxide/titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73541-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.5 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	20 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SUNFLOWER OIL (UNII: 3W1JG795YI)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
COCO-CAPRYLATE (UNII: 4828G836N6)
YELLOW WAX (UNII: 2ZA36H0S2V)
LIMONIA ACIDISSIMA WHOLE (UNII: MU5C4X2819)
ALUMINUM OXIDE (UNII: LMI26O6933)
ISOAMYL LAURATE (UNII: M1SLX00M3M)
STEARIC ACID (UNII: 4ELV7Z65AP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73541-003-01	120 mL in 1 TUBE; Type 0: Not a Combination Product	05/17/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/17/2024

Labeler - Alive 2 Dive Co Ltd (662332223)

Establishment
Name	Address	ID/FEI	Business Operations
Alive 2 Dive Co Ltd		662332223	manufacture(73541-003)