Otc - Active Ingredient
Active ingredient
Zinc Oxide, 20%
Reef Repair Spf 30
FDA Label NDC 73541-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Alive 2 Dive Company Limited for the product Reef Repair Spf 30 (NDC 73541-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, dosage & administration, inactive ingredient, other safety information, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - 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)
* Please review the disclaimer below.
