Hybrid Spf

Hybrid Spf
SPL v2
SPL
SPL Set ID 5c99f98c-025c-4886-824f-af968033baf4
Route
TOPICAL
Published
Effective Date 2026-01-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (80 mg) Octisalate (50 mg) Zinc Oxide
Inactive Ingredients
Allantoin Aloe Vera Leaf Adansonia Digitata Seed Oil Butyloctyl Salicylate Calendula Officinalis Seed Oil Green Tea Leaf Medium-chain Triglycerides Caprylyl Glycol Safflower Oil Polyoxyl 20 Cetostearyl Ether Citric Acid Monohydrate Citrus Aurantium Fruit Oil Coconut Oil Carrot Juice Decyl Glucoside Dodecane Glyceryl Laurate Glyceryl Stearate Citrate Glyceryl Monostearate Glycerin Niacinamide Polyhydroxystearic Acid (2300 Mw) Polysorbate 20 Sorbitan Monostearate Starch, Tapioca .alpha.-tocopherol Glyceryl 1-undecylenate Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-10-07

Description

Drug Facts


Medication Information

Description

Drug Facts

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.
Section 42229-5

Drug Facts

Section 50565-1

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

Section 50566-9

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

Section 50567-7

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

Section 50570-1

Do not use on damaged or broken skin.

Section 55105-1
Active ingredients Purpose
Octocrylene 8.00% Sunscreen
Octisalate 5.00% Sunscreen
Zinc Oxide 5.00% Sunscreen
Warnings

For external use only.

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]


Structured Label Content

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.
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

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

Section 50570-1 (50570-1)

Do not use on damaged or broken skin.

Section 55105-1 (55105-1)
Active ingredients Purpose
Octocrylene 8.00% Sunscreen
Octisalate 5.00% Sunscreen
Zinc Oxide 5.00% Sunscreen
Warnings

For external use only.

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 (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 (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]


Advanced Ingredient Data


Raw Label Data

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