FDA.reportPublic FDA data

Sudden Change Derma Renewal Complex

Manufacturer
CCA Industries Inc.
Effective date
2021-09-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:42:20

Label at a glance#

ProductSudden Change Derma Renewal Complex
Active ingredientOCTINOXATE, ZINC OXIDE
Label structure8 sections

Indications and uses

Hepls prevent sunburn

Dosage and administration

For sunsreen use: apply liberally 15 minutes before sun exposure. Use a water resistant sunscreen if swimming or sweating. Reapply at least every 2 hours. Children under 6 months: ask a doctor.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 6.00%

Zinc oxide 2.00%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses:

INDICATIONS & USAGE SECTION

Hepls prevent sunburn

Warnings

WARNINGS SECTION

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

For external use only. 

Do not use 

OTC - DO NOT USE SECTION

on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

OTC - STOP USE SECTION

if rash occurs.

Keep out of the reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • For sunsreen use: apply liberally 15 minutes before sun exposure. Use a water resistant sunscreen if swimming or sweating. Reapply at least every 2 hours. Children under 6 months: ask a doctor.

Other Information

SPL UNCLASSIFIED SECTION

  • Protect this product from excessive heat and direct sun.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

WATER (AQUA), BUTYLENE GLYCOL, CAPRYLIC/CAPRIC TRIGLYCERIDE, SIMMONDSIA, CHINENSIS (JOJOBA) SEED OIL, GLYCERIN, DIMETHICONE, CETEARYL OLIVATE, HYDROGENATED OLIVE OIL, UNSAPONIFIABLES, CETYL ALCOHOL, SORBITAN OLIVATE, ALOE BARBADENSIS LEAF EXTRACT, CAMELLIA SINENSIS LEAF EXTRACT, TOCOPHERYL ACETATE, TETRAHEXYLDECYL ASCORBATE, SODIUM HYALURONATE, C12-15 ALKYL BENZOATE, TRIBEHENIN, CERAMIDE NG, PEG-10 RAPESEED STEROL, PALMITOYL HEXAPEPTIDE-12, XANTHAN GUM, ALLANTOIN, TRIETHOXYCAPRYLYLSILANE, PHENOXYETHANOL, CAPRYLYL GLYCOL, POTASSIUM SORBATE, HEXYLENE GLYCOL, BISABOLOL, FRAGRANCE, CITRUS AURANTIUM (NEROLI) FLOWER OIL

Questions or Comments?

OTC - QUESTIONS SECTION

Call 1-800-595-6230

Report any issues associated with this product to the telephone number or address listed on this package.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label4Label4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61543-0003-02024-01-30C16284748780-1ba0f9c33-3a08-a910-e053-dadaa90a0b85Sudden Change Derma Renewal Complex
61543-0003-02021-09-09C16284748780-1ba0f9c33-3a08-a910-e053-dadaa90a0b85Sudden Change Derma Renewal Complex
61543-0003-02021-01-29C16284748780-1ba0f9c33-3a08-a910-e053-dadaa90a0b85Sudden Change Derma Renewal Complex

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61543-0003-0Sudden Change Derma Renewal Complex30 mL in 1 TUBECREAM302
61543-0003-0Sudden Change Derma Renewal Complex1 in 1 BOXCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61543-0003SUDDEN CHANGE DERMA RENEWAL COMPLEX (OCTINOXATE, ZINC OXIDE) CREAM [CCA INDUSTRIES INC.]2Legacy NDC, 2 package rows20210910_d49548e2-f883-4b31-8a96-3d58f9ce24b6.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 34 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61543-000361543-0003-0

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
GLYCERINPDC6A3C0OXIACT
DIMETHICONE92RU3N3Y1OIACT
CETEARYL OLIVATE58B69Q84JOIACT
HYDROGENATED OLIVE OIL53839415GIIACT
OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLESXO45V955LTIACT
CETYL ALCOHOL936JST6JCNIACT
SORBITAN OLIVATEMDL271E3GRIACT
ALOE VERA LEAFZY81Z83H0XIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
HYALURONATE SODIUMYSE9PPT4THIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
TRIBEHENIN8OC9U7TQZ0IACT
CERAMIDE NGC04977SRJ5IACT
PEG-10 RAPESEED STEROL258O76T85MIACT
PALMITOYL HEXAPEPTIDE-12HO4ZT5S86CIACT
XANTHAN GUMTTV12P4NEEIACT
ALLANTOIN344S277G0ZIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CAPRYLYL GLYCOL00YIU5438UIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
HEXYLENE GLYCOLKEH0A3F75JIACT
LEVOMENOL24WE03BX2TIACT
CITRUS AURANTIUM FLOWER OILD4BGE91OXHIACT
OCTINOXATE4Y5P7MUD51ACTIB
ZINC OXIDESOI2LOH54ZACTIM

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
cb79926a-8c17-c7eb-e053-2a95a90a58bfd49548e2-f883-4b31-8a96-3d58f9ce24b62021-09-08WarningsExact identifier
spl id: cb79926a-8c17-c7eb-e053-2a95a90a58bf
spl set id: d49548e2-f883-4b31-8a96-3d58f9ce24b6

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.