Moisturizing Antioxidant

Moisturizing Antioxidant
SPL v1
SPL
SPL Set ID 727c14d3-ad26-4e8b-91f6-b7a5f07e4e2f
Route
TOPICAL
Published
Effective Date 2026-01-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octisalate (50 mg) Octinoxate (75 mg) Oxybenzone (70 mg) Homosalate (60 mg) Zinc Oxide
Inactive Ingredients
.alpha.-bisabolol, (+)- Caffeine Green Tea Leaf Medium-chain Triglycerides Caprylyl Glycol Cetostearyl Alcohol Cetyl Phosphate Cucumber C13-14 Isoparaffin Dimethicone 200 Edetate Disodium Disodium Lauriminodipropionate Disodium Lauriminodipropionate Tocopheryl Phosphates Ectoine Ethylene Brassylate Glycerin Glyceryl Monostearate Laureth-7 Peg-12 Dimethicone (300 Cst) Peg-100 Monostearate Phenoxyethanol Polyacrylamide (10000 Mw) Polysorbate 60 Milk Thistle Hyaluronate Sodium Squalane Sorbic Acid Triethoxycaprylylsilane Water Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-01-01

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 55105-1
Active ingredients
Octinoxate 7.5% Sunscreen
Octisalate 5.0% Sunscreen
Homosalate 7.0% Sunscreen
Oxybenzone 5.0% Sunscreen
Zinc Oxide 6.0% Sunscreen
Warnings

For external use only.

Directions

Apply liberally 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

Bisabolol, Caffeine, Camellia Sinensis (Green Tea) Polyphenols, Caprylic/Capric Triglyceride, Caprylyl Glycol, Cetearyl Alcohol, Cetyl Phosphate, Cucumis Sativus (Cucumber) Fruit Extract, C13-14 Iso-Paraffin, Dimethicone, Disodium EDTA, Disodium Lauriminodipropionate Tocopheryl Phosphates, Ectoin, Ethylene Brassylate, Glycerin, Glyceryl Stearate, Laureth-7, PEG-12 Dimethicone, PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Polysorbate-60, Silybum (Silymarin) Marianum Fruit Extract, Sodium Hyaluronate, Squalane, Sorbic Acid, Triethoxycaprylylsilane, Water, Xanthan Gum.

Principal Display Panel 120 Ml Can Label

COMPLIMENTS OF

TOPIX

PHARMACEUTICALS, INC

DAILY

Moisturizing

Antioxidant Sunscreen

SPF 50+

Broad Spectrum SPF 50+

Net 4 fl. oz. (120 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 55105-1 (55105-1)
Active ingredients
Octinoxate 7.5% Sunscreen
Octisalate 5.0% Sunscreen
Homosalate 7.0% Sunscreen
Oxybenzone 5.0% Sunscreen
Zinc Oxide 6.0% Sunscreen
Warnings

For external use only.

Directions

Apply liberally 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)

Bisabolol, Caffeine, Camellia Sinensis (Green Tea) Polyphenols, Caprylic/Capric Triglyceride, Caprylyl Glycol, Cetearyl Alcohol, Cetyl Phosphate, Cucumis Sativus (Cucumber) Fruit Extract, C13-14 Iso-Paraffin, Dimethicone, Disodium EDTA, Disodium Lauriminodipropionate Tocopheryl Phosphates, Ectoin, Ethylene Brassylate, Glycerin, Glyceryl Stearate, Laureth-7, PEG-12 Dimethicone, PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Polysorbate-60, Silybum (Silymarin) Marianum Fruit Extract, Sodium Hyaluronate, Squalane, Sorbic Acid, Triethoxycaprylylsilane, Water, Xanthan Gum.

Principal Display Panel 120 Ml Can Label (PRINCIPAL DISPLAY PANEL - 120 ml Can Label)

COMPLIMENTS OF

TOPIX

PHARMACEUTICALS, INC

DAILY

Moisturizing

Antioxidant Sunscreen

SPF 50+

Broad Spectrum SPF 50+

Net 4 fl. oz. (120 ml)

Available

Custom Branded

800.445.2595

[email protected]


Advanced Ingredient Data


Raw Label Data

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