OTC - ACTIVE INGREDIENT SECTION
Active ingredients--------------purpose
PEG-100 STEARATE------------ Sunscreen SPF30
TITANIUM DIOXIDE
ETHYLHEXYL METHOXYCINNAMATE
BUTYL METHOXYDIBENZOYLMETHANE
Active ingredients--------------purpose
PEG-100 STEARATE------------ Sunscreen SPF30
TITANIUM DIOXIDE
ETHYLHEXYL METHOXYCINNAMATE
BUTYL METHOXYDIBENZOYLMETHANE
Warnings:
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. Keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash or irritation develops and lasts. Keep out of reach of children. If swallowed: seek medical help or contact a poison control center right away.
Directions:
Apply liberally 15 minutes before sun exposure and reapply as need.
Children under 6 months: ask a doctor before use.
Inactive Ingredients:
MINERAL OIL, SILICON, 4-HYDROXYBENZOIC ACID, PROPYL ACETATE, MONOGLYCERIDE CITRATE, GETOSTEARYL ALCOHOL, SODIUM DODECYLBENZENESULFONATE, CYCLOMETHICONE, ETHYLENE GLYCOL, WATER, XANTHAN GUM, CARBOMER 940, ALLANTOIN, GLYCERIN, 1,2-BUTANEDIOL, GPL
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 47993-216-01 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-e9f5-a426-e053-dadaa90af4c2 | Active Ingredients |
| 47993-216-02 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-e9f5-a426-e053-dadaa90af4c2 | Active Ingredients |
| 47993-216-03 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-e9f5-a426-e053-dadaa90af4c2 | Active Ingredients |
| 47993-216-04 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-e9f5-a426-e053-dadaa90af4c2 | Active Ingredients |
| 47993-216-05 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-e9f5-a426-e053-dadaa90af4c2 | Active Ingredients |
| 47993-216-06 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-e9f5-a426-e053-dadaa90af4c2 | Active Ingredients |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 47993-216-01 | Sunscreen SPF30 | 10 g in 1 TUBE | LIQUID | 10 | 4 | |
| 47993-216-02 | Sunscreen SPF30 | 15 g in 1 TUBE | LIQUID | 15 | 4 | |
| 47993-216-03 | Sunscreen SPF30 | 20 g in 1 TUBE | LIQUID | 20 | 4 | |
| 47993-216-04 | Sunscreen SPF30 | 30 g in 1 TUBE | LIQUID | 30 | 4 | |
| 47993-216-05 | Sunscreen SPF30 | 50 g in 1 TUBE | LIQUID | 50 | 4 | |
| 47993-216-06 | Sunscreen SPF30 | 60 g in 1 TUBE | LIQUID | 60 | 4 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| AVOBENZONE | ACTIVE INGREDIENT | G63QQF2NOX | 1 | |
| BENZOPHENONE | ACTIVE INGREDIENT | 701M4TTV9O | 1 | |
| ETHYLHEXYL METHOXYCRYLENE | ACTIVE INGREDIENT | S3KFG6Q5X8 | 1 | |
| PEG-100 Stearate | ACTIVE INGREDIENT | YD01N1999R | 1 | |
| TITANIUM DIOXIDE | ACTIVE INGREDIENT | 15FIX9V2JP | 1 | |
| AVOBENZONE | ACTIVE MOIETY | G63QQF2NOX | 1 | |
| BENZOPHENONE | ACTIVE MOIETY | 701M4TTV9O | 1 | |
| ETHYLHEXYL METHOXYCRYLENE | ACTIVE MOIETY | S3KFG6Q5X8 | 1 | |
| PEG-100 Stearate | ACTIVE MOIETY | YD01N1999R | 1 | |
| TITANIUM DIOXIDE | ACTIVE MOIETY | 15FIX9V2JP | 1 | |
| 1,2-Butanediol | INACTIVE INGREDIENT | RUN0H01QEU | 1 | |
| 4-HYDROXYBENZOIC ACID | INACTIVE INGREDIENT | JG8Z55Y12H | 1 | |
| ALLANTOIN | INACTIVE INGREDIENT | 344S277G0Z | 1 | |
| Carbomer 940 | INACTIVE INGREDIENT | 4Q93RCW27E | 1 | |
| Cetostearyl Alcohol | INACTIVE INGREDIENT | 2DMT128M1S | 1 | |
| CYCLOMETHICONE | INACTIVE INGREDIENT | NMQ347994Z | 1 | |
| DMDM HYDANTOIN | INACTIVE INGREDIENT | BYR0546TOW | 1 | |
| ethylene glycol | INACTIVE INGREDIENT | FC72KVT52F | 1 | |
| Glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| MINERAL OIL | INACTIVE INGREDIENT | T5L8T28FGP | 1 | |
| MONOGLYCERIDE CITRATE | INACTIVE INGREDIENT | 4987GT719I | 1 | |
| Propyl acetate | INACTIVE INGREDIENT | 4AWM8C91G6 | 1 | |
| SILICON | INACTIVE INGREDIENT | Z4152N8IUI | 1 | |
| SODIUM DODECYLBENZENESULFONATE | INACTIVE INGREDIENT | 554127163Y | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 | |
| Xanthan gum | INACTIVE INGREDIENT | TTV12P4NEE | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 47993-216 | 47993-216-01, 47993-216-02, 47993-216-03, 47993-216-04, 47993-216-05, 47993-216-06 |
Every source-derived ingredient row is available through these pages.
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| Glycerin | GLYCERIN | PDC6A3C0OX | SUSPENSION / ORAL | 26208 mg | ||
| Cetostearyl Alcohol | CETOSTEARYL ALCOHOL | 2DMT128M1S | AEROSOL, FOAM / TOPICAL | 21 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / SUBCUTANEOUS | 15 %w/v | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | TABLET / PERIODONTAL | 0.53 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SUSPENSION / TOPICAL | 82 %w/w | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | AEROSOL, FOAM / TOPICAL | 21 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | LOTION / TOPICAL | 1428 mg | ||
| Xanthan gum | XANTHAN GUM | TTV12P4NEE | TABLET, FILM COATED / ORAL | 0.08 mg | ||
| Carbomer 940 | CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) | 4Q93RCW27E | CREAM, AUGMENTED / TOPICAL | 20 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | INJECTION / INTRADERMAL | 1.6 %w/v | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION/ DROPS / OPHTHALMIC | 12 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | TABLET, EXTENDED RELEASE / ORAL | NA | ||
| Xanthan gum | XANTHAN GUM | TTV12P4NEE | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 6 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | FILM, EXTENDED RELEASE / BUCCAL | 34 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | PASTE / DENTAL | 95 %w/w | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SOAP / TOPICAL | 0.76 %w/w | ||
| CYCLOMETHICONE | CYCLOMETHICONE | NMQ347994Z | CREAM / TOPICAL | 13 %w/w | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | MOUTHWASH / BUCCAL | 100 mg/1ml | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | EMULSION / OPHTHALMIC | 3 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | CREAM / VAGINAL | 60 mg | ||
| CYCLOMETHICONE | CYCLOMETHICONE | NMQ347994Z | AEROSOL, FOAM / TOPICAL | 5.26 %w/w | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION / NASAL | 25 mg/1ml | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | DROPS / NASAL | 10 mg/1ml | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | DROPS / ORAL | NA | ||
| Xanthan gum | XANTHAN GUM | TTV12P4NEE | SUSPENSION / OPHTHALMIC | 2 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | DOUCHE / VAGINAL | 1 %w/w | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | LOTION / TOPICAL | 3990 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | GEL / OPHTHALMIC | 0.88 %w/w | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | PASTE / ORAL | 3822 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / INTRAMUSCULAR | 15 %w/v | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION / OPHTHALMIC | 6 %w/v | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | CAPSULE, LIQUID FILLED / ORAL | 185 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SHAMPOO / TOPICAL | 5 %w/w | ||
| SILICON | SILICON | Z4152N8IUI | POWDER, FOR SUSPENSION / ORAL | NA | ||
| Xanthan gum | XANTHAN GUM | TTV12P4NEE | LOZENGE / ORAL | 1264 mg | ||
| Xanthan gum | XANTHAN GUM | TTV12P4NEE | SUSPENSION / ORAL | 360 mg | ||
| Xanthan gum | XANTHAN GUM | TTV12P4NEE | POWDER, FOR SUSPENSION / ORAL | 600 mg | ||
| Xanthan gum | XANTHAN GUM | TTV12P4NEE | SUSPENSION / TOPICAL | 0.11 %w/v | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | PASTE, DENTIFRICE / DENTAL | 18 %w/w | ||
| Cetostearyl Alcohol | CETOSTEARYL ALCOHOL | 2DMT128M1S | LOTION / TOPICAL | 3627 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SUSPENSION/ DROPS / OPHTHALMIC | 2.5 %w/v | ||
| Cetostearyl Alcohol | CETOSTEARYL ALCOHOL | 2DMT128M1S | CAPSULE, EXTENDED RELEASE / ORAL | 9.43 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SPRAY, METERED / NASAL | 13 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SPRAY / NASAL | 22.3 mg/1ml | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | INJECTION / INTRAMUSCULAR | 450 mg | ||
| CYCLOMETHICONE | CYCLOMETHICONE | NMQ347994Z | CREAM, AUGMENTED / TOPICAL | 7.6 %w/w | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | LIQUID / TOPICAL | 2.5 %w/w | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | JELLY / TOPICAL | NA | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SUPPOSITORY / RECTAL | 440 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / INTRAVENOUS | 15 %w/v | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | CAPSULE, EXTENDED RELEASE / ORAL | 265 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | INJECTION, SUSPENSION / SUBCUTANEOUS | 1.6 %w/v | ||
| Xanthan gum | XANTHAN GUM | TTV12P4NEE | SOLUTION / OPHTHALMIC | 0.6 %w/v | ||
| Xanthan gum | XANTHAN GUM | TTV12P4NEE | TABLET / ORAL | 56 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | CAPSULE, EXTENDED RELEASE / ORAL | 120 mg | ||
| SILICON | SILICON | Z4152N8IUI | SUSPENSION / ORAL | NA | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION / RESPIRATORY (INHALATION) | 5 %w/w | ||
| Carbomer 940 | CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) | 4Q93RCW27E | LOTION / TOPICAL | 300 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SYSTEM / TRANSDERMAL | 6.09 mg | ||
| Xanthan gum | XANTHAN GUM | TTV12P4NEE | PASTE / ORAL | 1050 mg |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 63098fb5-2144-79dd-e053-2a91aa0a1ad7 | c16e8c37-6773-4fc9-9ea8-bda005742988 | 2018-01-18 | Warnings | 63098fb5-2144-79dd-e053-2a91aa0a1ad7 c16e8c37-6773-4fc9-9ea8-bda005742988 |
Adverse event summaries are temporarily unavailable. Other product information remains available.