FDA Label for By The Beach Suncare
View Indications, Usage & Precautions
By The Beach Suncare Product Label
The following document was submitted to the FDA by the labeler of this product By The Beach Suncare Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient(S)
Octocrylene (10%) – Sunscreen
Octisalate (5%) – Sunscreen
Avobenzone (3%) – Sunscreen
Purpose
Sunscreen
Use
Helps prevent sunburn
If used with other sun protection measures (see below), helps decrease the risk of skin cancer and early skin aging caused by the sun
Warnings
Skin Cancer / Skin Aging Alert: Spending time in the sun increases your risk of skin cancer & early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
Over-exposure to the sun is a serious health threat.
Do not use on damaged and/or broken skin.
When using this product keep out of eyes. Rinse with water to remove. External use only.
Stop use and ask a doctor if rash occurs.
Keep infants out of direct sunlight.
Do not stay too long in the sun, even while using a sunscreen product.
Re-apply frequently to maintain protection, especially after perspiring, swimming or toweling.
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. – 2 p.m.
Wear long-sleeved shirts, pants, hats and sunglasses
Otc - Keep Out Of Reach Of Children
Keep out of reach of childeren. Contact a Poison Control Center: This is the emergency contact for accidental overdose or ingestion
Directions
Shake well. Apply liberally and evenly 15–20 minutes before sun exposure.
Apply to all skin exposed to the sun.
Children under 6 months of age: Ask a doctor.
Re-apply immediately after spending time in the water.
Re-apply at least every 2 hours. Use a water-resistant sunscreen if swimming or sweating.
Warning: Reducing this quantity will lower the level of protection significantly.
Other Information
Protect the product in this container from excessive heat or direct sun.
This product helps with UVA & UVB protection.
Inactive Ingredients
AQUA, OCTOCRYLENE, ETHYLHEXYL SALICYLATE (OCTISALATE), PROPYLENE GLYCOL, ETHYLHEXYL PALMITATE, BUTYL METHOXYDIBENZOYLMETHANE (AVOBENZONE), GLYCERYL STEARATE, PEG-100 STEARATE, LITHIUM MAGNESIUM SILICATE, ELAEIS GUINEENSIS (PALM) OIL, PHENOXYETHANOL, STEARYL ALCOHOL, POLYACRYLAMIDE, FRAGRANCE, POTASSIUM CETYL PHOSPHATE, C13-14 ISOPARAFFIN, XANTHAN GUM, DIMETHICONE, CETYL ALCOHOL, LAURETH-7, ELAEIS GUINEENSIS (PALM) KERNEL OIL, ETHYLHEXYLGLYCERIN, HYDROXYETHYLCELLULOSE, DIMETHICONOL, CI 19140, SODIUM CHLORIDE, DISODIUM PHOSPHATE, POLYSORBATE 60, CI 42090, SODIUM PHOSPHATE
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