FDA.reportPublic FDA data

DD Cream SPF 30

Manufacturer
PML NYC, LLC
Effective date
2026-04-15
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:54:04

Label at a glance#

ProductDD Cream Dermatologically Defining BB Cream Broad Spectrum SPF 30
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure10 sections

Dosage and administration

Apply liberally 15 minutes before sun exposure Reapply at least every 2 hours Use water resistant sunscreen if swimming or sweathing Sun Protection Measures: Spending time in the sun decreases risk of skin cancer and early again. To decrease this risk, regulaory 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 10:00 a...

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 3.30%

Zinc Oxide 12.05%

USE

OTC - PURPOSE SECTION

  • 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

WARNINGS SECTION

  • For external use only
  • Do not use on damaged or broken skin
  • When using this product keep out of eyes. Rinse with water to remove.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure
  • Reapply at least every 2 hours
  • Use water resistant sunscreen if swimming or sweathing
  • Sun Protection Measures: Spending time in the sun decreases risk of skin cancer and early again. To decrease this risk, regulaory 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 10:00 am - 2:00 pm. Wear long sleeved shirts, pants, hats and sunglasses.
  • Children under 6 months: ask a doctor

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Alumina, Aluminum Hydroxide, Behenyl Alcohol, Butylene Glycol, C12-15 Alkyl Benzoate, Caprylic/Capric/Myristic/Stearic Triglyceride, Caprylyl Glycol, Carbomer, Cellulose Gum, Cety Alcohol, Dextrin Palmitate, Dimethicone, Dimethylacrylamide/Acrylic Acid/Plystyrene Ethyl Methacylate, Disodium EDTA, Ethoxydiglycol, Ethylhexylglycerin, Glycerin, Hexylene Glycol, Hydrogenated Lecithin, Isostearic Acid, Lycium Barbarum Fruit Extract, Lysine, Magnesium Chloride, Nordihydroguaiaretic Acid, Octyldodecyl Neopenanoate, Oleanolic Acid, Palmitoyl Hexapeptide-14, Panthenol, PEG-60 Almond Glycerides, Phenoxyethanol, Phospholipids, Phytantriol, Polygleceryl-3 Diisostearate, Polysorbate 80, Potassium Chloride, Silica, Sodium Benozate, Sodium Chloride, Sodium Dehydroacetate, Sodium Hyaluronate Crosspolymer, Sodium Hydroxide, Squalane, Steareth-2, Steareth-21, Stearic Acid, Superoxide Dismutase, Tetrahexyldecyl Ascorbate, Tocopherol, Tocopheryl Acetate, Triethoxycaprylylsilane, Triethylhexanoin, Water, Xanthan Gum, Zinc Chloride May Contain (+/-): Mica, Iron Oxides.

OTHER INFORMATION

OTHER SAFETY INFORMATION

  • Protect this product form excessive heat and direct sun

INDICATIONS & USAGE SECTION

Stop use and ask a doctor if rash occurs.

RECENT MAJOR CHANGES SECTION

Dosage & Admin update

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DD CreamDD Cream

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
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9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
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7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
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ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59735-565-01DD Cream Dermatologically Defining BB Cream Broad Spectrum SPF 3040 g in 1 TUBECREAM403
59735-565-01DD Cream Dermatologically Defining BB Cream Broad Spectrum SPF 301 in 1 CARTONCREAM13

Products#

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

DailyMed product names page 1 of 2 · 51 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59735-56559735-565-01

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 50 matching rows.

Name, UNII, Kind table
NameUNIIKind
CETYL ALCOHOL936JST6JCNIACT
WATER059QF0KO0RIACT
DEXTRIN PALMITATE (CORN; 20000 MW)89B2BSF9I3IACT
2,3-DIMETHYLACRYLIC ACID, (E)-I5792N03HCIACT
ETHOXYDIGLYCOL BEHENATEN76ISC4ZZOIACT
HEXYLENE GLYCOLKEH0A3F75JIACT
LYSINEK3Z4F929H6IACT
NORDIHYDROGUAIARETIC ACID, (+/-)-7PZ73W4ZNRIACT
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
PALMITOYL HEXAPEPTIDE-12HO4ZT5S86CIACT
PHENOXYETHANOLHIE492ZZ3TIACT
EGG PHOSPHOLIPIDS1Z74184RGVIACT
POLYGLYCERYL-3 DISTEARATEZI1LK470XVIACT
POLYSORBATE 806OZP39ZG8HIACT
POTASSIUM CHLORIDE660YQ98I10IACT
SILICONZ4152N8IUIIACT
SODIUM CHLORIDE451W47IQ8XIACT
SQUALANEGW89575KF9IACT
STEARIC ACID4ELV7Z65APIACT
SUPEROXIDE DISMUTASE (CU-ZN) SACCHAROMYCES CEREVISIAEZQP6EKT6WDIACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
TRIETHYLHEXANOIN7K3W1BIU6KIACT
XANTHAN GUMTTV12P4NEEIACT
BEHENYL BEHENATEK8NU647RJ0IACT
CAPRYLIC/CAPRIC/PALMITIC/STEARIC TRIGLYCERIDEZF29F7IK5IIACT
.ALPHA.-CELLULOSEI355QGZ19AIACT
DISODIUM EDTA-COPPER6V475AX06UIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
BUTYLENE GLYCOL3XUS85K0RAIACT
LYCIUM BARBARUM FRUIT930626MWDLIACT
MAGNESIUM CHLORIDE02F3473H9OIACT
OLEANOLIC ACID6SMK8R7TGJIACT
PANTHENOLWV9CM0O67ZIACT
PEG-60 ALMOND GLYCERIDES4Y0E651N0FIACT
PHYTANTRIOL8LVI07A72WIACT
DIMETHICONE92RU3N3Y1OIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM DEHYDROACETATE8W46YN971GIACT
HYDROGENATED SOYBEAN LECITHINH1109Z9J4NIACT
ISOSTEARIC ACIDX33R8U0062IACT

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
DD Cream Dermatologically Defining BB Cream Broad Spectrum SPF 30DD CREAM DERMATOLOGICALLY DEFINING BB CREAM BROAD SPECTRUM SPF 30PML NYC, LLCea90bb4d-6f4a-45c9-e053-2a95a90a53a72026-04-15WarningsExact identifier
ndc (package): 59735-565-01
ndc (product): 59735-565
ndc11 (package): 59735056501
spl id: 4f8555ce-19a0-8554-e063-6394a90a72f1
spl set id: ea90bb4d-6f4a-45c9-e053-2a95a90a53a7

Reported adverse events (FAERS/openFDA)#

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