308c711d-4c3e-1208-e063-6394a90a9cc2

Set ID
308c711d-4c3e-1208-e063-6394a90a9cc2
Manufacturer
Cali Skin Care LLC | Custom Analytics LLC | Fragrance Manufacturing Inc. | Fallien Cosmeceuticals Ltd.
Effective date
2025-12-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:20:55

Key Label Information

Active Ingredients And Purpose

Active Ingredients:

Zinc Oxide 20%

Purpose:

Sunscreen

Uses

Uses:

Helps prevent sunburn. If used as directed with other sun protection measures (see directions), decreases the risk of skin cancer and early aging caused by the sun.

Warnings

Warnings:

For external use only. Do not use on damaged or broken skin. Stop use and ask a doctor if rash occurs. When using this product, keep out of eyes. Rinse with water to remove. Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Warnings:

Keep out of reach of children

Directions And Dosage

Directions:

• Apply liberally 15 minutes before sun exposure • Reapply: • After 40 minutes of swimming or sweating • Immediately after towel drying • Reapply at least every 2 hours • Children under 6 months: Ask 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 value of 15 or higher and other sun protection measures including: • Limit time in the sun, especially from 10 am- 2 pm • Wear long sleeve shirts and hats and sunglasses

Other Label Information

Inactive Ingredients:

C12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Disodium EDTA, Glycerin, Hydrogen Dimethicone, Microcrystalline Wax, PEG-10 Dimethicone, PEG-30 Dipolyhydroxystearate, Polyglyceryl-4 Isostearate, Polyhydroxystearic Acid, Polysorbate 20, Sodium Chloride, Stearyl Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Triethanolamine, Triethoxycaprylylsilane, Water

Products

NDC Codes

Ingredients

NameUNIIKind
DIMETHICONE92RU3N3Y1OIACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
POLYGLYCERYL-4 ISOSTEARATE820DPX33S7IACT
SODIUM CHLORIDE451W47IQ8XIACT
C12-15 ALKYL BENZOATEA9EJ3J61HQIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
WATER059QF0KO0RIACT
ZINC OXIDESOI2LOH54ZACTIB
CYCLOHEXASILOXANEXHK3U310BAIACT
DIMETHICONOL (2000 CST)T74O12AN6YIACT
CYCLOPENTASILOXANE0THT5PCI0RIACT
CAPRYLYL GLYCOL00YIU5438UIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
POLYSORBATE 207T1F30V5YHIACT
PEG-30 DIPOLYHYDROXYSTEARATE9713Q0S7FOIACT
STEARYL DIMETHICONE (400 MPA.S AT 50C)R327X197HYIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
DIMETHICONE CROSSPOLYMERUF7620L1W6IACT
GLYCERINPDC6A3C0OXIACT
HYDROGEN DIMETHICONE (20 CST)12Z59IF64NIACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4)8INO2K35FAIACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
TRIETHANOLAMINE9O3K93S3TKIACT

Complete SPL Sections

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 20%

Purpose:

OTC - PURPOSE SECTION

Sunscreen

Uses:

INDICATIONS & USAGE SECTION

Helps prevent sunburn. If used as directed with other sun protection measures (see directions), decreases the risk of skin cancer and early aging caused by the sun.

Warnings:

WARNINGS SECTION

For external use only. Do not use on damaged or broken skin. Stop use and ask a doctor if rash occurs. When using this product, keep out of eyes. Rinse with water to remove. Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Directions:

DOSAGE & ADMINISTRATION SECTION

• Apply liberally 15 minutes before sun exposure • Reapply: • After 40 minutes of swimming or sweating • Immediately after towel drying • Reapply at least every 2 hours • Children under 6 months: Ask 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 value of 15 or higher and other sun protection measures including: • Limit time in the sun, especially from 10 am- 2 pm • Wear long sleeve shirts and hats and sunglasses

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

C12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Disodium EDTA, Glycerin, Hydrogen Dimethicone, Microcrystalline Wax, PEG-10 Dimethicone, PEG-30 Dipolyhydroxystearate, Polyglyceryl-4 Isostearate, Polyhydroxystearic Acid, Polysorbate 20, Sodium Chloride, Stearyl Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Triethanolamine, Triethoxycaprylylsilane, Water

Other Information:

OTHER SAFETY INFORMATION

• Protect this product from excessive heat and direct sun • May stain some fabrics.

Warnings:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

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XML SHA-256
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XML bytes
25110

Legacy File Index

FolderFileDate
otc4586c8f3-33e6-111f-e063-6394a90ad8dd.xml2025-12-10
otc308c711d-4c3f-1208-e063-6394a90a9cc2.xml2025-03-21
otcClinically Clear Skin Rehab Center Skin Tone Defender.jpg2025-03-21