Otc - Active Ingredient
Active ingredients Purpose
Avobenzone 3.0, Octisalate 5.0% Octocrylene 8.0% Sunscreen
Coconut Vanilla Body Broad Spectrum Spf 50
FDA Label NDC 71014-094
9 label sections · Submitted to the FDA by Eai-jr286, Inc · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Eai-jr286, Inc for the product Coconut Vanilla Body Broad Spectrum Spf 50 (NDC 71014-094). 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, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Uses
- Helps prevent sunburn
- If used as directed with other sun protection measures (see D irections) decreases the risk of skin cancer and early skin aging caused by the sun
Otc - 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
Indications & Usage
Stop use and ask a doctor if
- rash occurs
Warnings
For external use only
Flammable: Do not use near heat, flame, or while smoking
Do not use
- on damaged or broken skin
- Keep out of eyes
- Rinse with water to remove
- Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F.
When using this product
Dosage & Administration
Directions:
- Apply Liberally 15 minutes before sun exposure
- Hold 4 to 6 inches away from body when spraying
- Children under 6 months of age: Ask a doctor
- Do not spray directly on face and avoid breathing mist
- Spray on hand and and apply to face. Use in a well-ventillated area
Sun Protection Measures:
Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen 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.- 2p.m.
Wear long sleeved shirts, pants, hats and sunglasses
Reapply: After 80 minutes of swimming. Immediately after towel use or at least every 2 hours
Inactive Ingredient
Inactive ingredients: Alcohol Denat., Acrylates/ Octylacrylamide Copolymer, Aloe Barbadensis Leaf Juice, Butyloctyl Salicylate, Diisopropyl Adipate, Fragrance, Persea Gratissima (Avocado) Oil, Tocopheryl Acetate
Other Safety Information
Protect the product in this container from excessive heat and direct sun
May stain some fabrics
Package Label.Principal Display Panel
vertra
50
Coconut Vanilla Body Spray
Broad Spectrum SPF 50
Water Resistant (80 Minutes)
NET WT 5 OZ (142 g)
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