Hybrid Spf Spray
FDA Label NDC 51326-128

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Topiderm, Inc. for the product Hybrid Spf (NDC 51326-128). 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 other, otc - purpose, uses, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, otc - do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Otc - Purpose

Active ingredientsPurpose
Octocrylene 8.00%Sunscreen
Octisalate 5.00%Sunscreen
Zinc Oxide 5.00%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.

Otc - When Using

When using this product keep out of eyes, rinse with water to remove.

Otc - Stop Use

Stop use if signs of irritation or rash appear. If irritation or rash persists consult a doctor.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Otc - Do Not Use

Do not use on damaged or broken skin.

Directions

  • Apply liberally and spread evenly by hand 15 minutes before sun exposure
  • Re-apply after swimming, excessive perspiring, or anytime after towel drying
  • Use a water resistant sunscreen if swimming or sweating
  • Use on children under 6 months of age: consult a doctor.
  • 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 of 15 or higher and other sunscreen measures including:
    • limit time in the sun, especially from 10 a.m. - 2 p.m.
    • wear long-sleeve shirts, pants, hats, and sunglasses

Inactive Ingredients

Adansonia Digitata (Baobab) Oil, Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Butyloctyl Salicylate, Calendula Officinalis Extract, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Oil, Cetereth-20, Citric Acid, Citrus Aurantium Dulcis (Orange) Oil, Cocos Nucifera (Coconut) Oil, Daucus Carota Sativa (Carrot) Extract, Decyl Glucoside, Dodecane, Glyceryl Laurate, Glyceryl Stearate SE, Glyceryl Stearate Citrate, Glyceryl Undecylenate, Glycerin, Niacinamide, Polyhydroxystearic Acid, Polysorbate-20, Sorbitan Stearate, Tapioca Starch, Tocopherol (Vitamin E), Xanthan Gum.

Principal Display Panel - 177 Ml Can Label

COMPLIMENTS OF
TOPIX
PHARMACEUTICALS, INC

DAILY

Sheer UV Protection
Sunscreen Spray
SPF 30

Broad Spectrum SPF 30
Water Resistant 80 Minutes
Fragrance Free
Aloe Vera
Green Tea

Net 6 fl. oz. (177 ml)

Available
Custom Branded
800.445.2595
[email protected]

Principal Display Panel (177 ml Can Label)

Principal Display Panel (177 ml Can Label)

* Please review the disclaimer below.