Sun Defense Spf 15
FDA Label NDC 63550-850

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kamins Dermatologics Inc. for the product Sun Defense Spf 15 (NDC 63550-850). 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, 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 - Active Ingredient

Active ingredients:

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Oxybenzone 6%

Otc - Purpose

Purpose: Sunscreen

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Indications & Usage

A broad spectrum UVA/UVB sunscreen to help protect the skin from sunburn. Sun Defense Spray SPF 15 is enriched with moisturizing açai oil, pomegranate extract and Bio-MapleTM compound to help skin remain hydrated.

Uses

■ Helps prevent sunburn.

■ Higher SPF gives more sunburn protection.

■ Provides high protection against sunburn.

Warnings

Warnings

For external use only.

When using this product, keep out of eyes. If contact occurs, rinse abundantly with water to remove.

Stop use and ask a doctor if rash or irritation develops and lasts.

If swallowed, seek medical assistance or contact a Poison Control Center immediately.

Flammable: Keep away from open flame or source of heat.  Do not use while smoking. Avoid long term storage above 40 °C (104°F)


Other information

Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.



Dosage & Administration

Directions

■ Apply 15-30 minutes before sun exposure.

■ Hold bottle 8-10 inches from the skin and press pump to spray a fine even mist.

■ Spray liberally and evenly over all exposed areas to ensure complete coverage.

■ Do not spray directly onto face; spray into hands, then immediately apply to face.

■ Rub into skin on all exposed areas.

■ Reapply every two hours or as needed, after swimming, washing, towel drying, or perspiring heavily.

Inactive Ingredient

Inactive ingredients: alcohol denat., ethyl macadamiate, tocopherol, malic acid, diethylhexyl 2,6-naphthalate, PPG-5-ceteth-20, acrylates/octylacrylamide copolymer, ethylene brassylate, lauryl PCA, tocopheryl acetate, acer saccharum (maple isolate), punica granatum (pomegranate) extract, propylene glycol, water, euterpe oleracea (acai) oil, retinyl palmitate, magnesium ascorbyl phosphate.

Package Label.Principal Display Panel

B. KAMINS

SUN DEFENSE SPRAY SPF15

150mL / 5 fl.oz

DIN 02312484

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Sun Defense Spray Spf Front Panel Image (Sundefense Spray)

Sun Defense Spray Spf Front Panel Image (Sundefense Spray)

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